דרושים Process Engineering Manager ב-West Pharma ב-United States, Williamsport

Responsible for providing expertise in Quality Assurance processes related to the manufacture of West products. Ensure compliance with regulatory requirements and West procedures. Proactively develop, lead, and drive the execution of the Quality Assurance strategy. Develop and implement quality assurance plans ensuring compliance with regulations, oversee interactions with regulatory agencies and build strong relationships with internal and external stakeholders. Champion advocacy for product, process, and system quality, and drive continuous improvement within the Quality Management System.

• Reporting to the Sr. Director, Quality Assurance, the role will play a critical part in the company’s business planning / strategy development.
• As a member of the Site Leadership Team, deeply engages and effectively contributes to the achievement of site objectives by playing an active role in the strategic planning processes
• The role will also have a dotted line reporting relationship to the Director, Operations, Williamsport to ensure development and alignment of the site business plan including support to the other senior managers in the execution of same
• Maintain a positive working relationship with internal and external stakeholders by supporting validation in design and development, specification development, and execution of manufacturing programs in line with agreed standards. All the while ensuring that West’s product quality and reliability meets or exceeds customers’ expectations.
• Directs and manages quality control, quality assurance, quality systems, metrology and/or regulatory affairs, personnel, department resources, and continuous improvement efforts to achieve the most efficient quality output possible.
• Partner with organizational leaders and drive quality initiatives, systems, and methods to meet quality objectives. Meet company and departmental goals in the continuous improvement of all products, services, and processes, including the West QMS. Support QMS activities including CAPA, Failure Investigation, Non-Conformance assessment, and audit findings.
• Perform the necessary functions in support of the Williamsport Quality System
  • Designated ISO 13485 Management Representative
  • Designated back-up to QA Supervisor for HACCP Manager and SQF Practitioner.
• In accordance with US and other regional/ country legislation, act as Head of Quality Control/ Head of Quality/ Official Correspondent on all government agency issued authorizations, communications and registrations.
• Cultivate a positive working relationship with the West Customer base via supporting validation in design and development, agreeing specification, execution of manufacturing and programs in line with agreed standards. All the while ensuring that the West’s product quality and reliability meets or exceeds customers’ expectations
• QA representative participating in customer face to face steering committees and business review which originate from site customer base. Chairing customer meetings with respect to Quality standards and expectations.
• Champion a quality/ patient first organizational culture that promotes behaviors that lead to superior quality and business performance and enterprise excellence.
• Participate in customer, regulatory, and internal audits of the plant; participate in supplier audits and participate as part of the Corporate Cross Site Audit Team.
• Review and assist on the updating of customer specifications. Respond to customer/sales regarding the approval or recommended changes to these specifications and maintain a file of the responses and the specifications.
• Oversees complaint handling, non-conformance management, internal and external audits, and CAPA system to ensure timely and compliant systems. Evaluates and provides for audits of external and internal quality systems and their functions, insuring follow through and corrective actions.
• Establish, monitors, and provides weekly / monthly progress of the Quality KPIs and communicate it to the organization and senior management.
• Responsible and accountable for quality departmental budget
• Other duties as assigned

• Bachelor's Degree in engineering, mechanical engineering, chemical engineering, manufacturing engineering, industrial engineering or equivalent experience required
• Master’s degree preferred

• 10+ Years of job-related experience required in the Medical Device or Pharmaceutical Industry.
• 8+ Years of supervisory experience required.
• 5+ Years of experience working with injection molding processes preferred.
• 5+ Years of experience in an FDA or ISO regulated industry required, preferably in medical device manufacturing.

• Regulatory Skills: In-depth knowledge of medical device and pharmaceutical regulations and guidelines, including cGMP, ICH guidelines and other relevant regulatory requirements (e.g. HACCP).
• Leadership Skills: Strong leadership and management skills with the ability to lead cross-functional teams, drive initiatives, and influence stakeholders at all levels of the organization.
• Communication Skills: Excellent communication skills, both written and verbal, with the ability to effectively communicate requirements and strategies to diverse audiences.
• Analytical Skills: Strong analytical and problem-solving skills, with the ability to analyze complex problems, identify root causes, and develop effective solutions.
• Adaptability: Flexibility and adaptability to navigate changing regulatory landscapes and business priorities.
• Ethical Standards : Adherence to ethical standards and integrity in dealing with regulatory agencies, colleagues, and stakeholders.
• Self-motivated with a proactive attitude and the ability to work effectively
• Project Management experience preferred

• Excellent communication and interpersonal skills must be coupled with public speaking, quick decision making.
• Excellent written and oral communication skills
• Medical component and device manufacturing require strict adherence to standards.
• Strong communication and technical writing skills, interpretation of data, interpersonal skills, ability to work on and lead teams
• Read and interpret data, information, and documents
• Must maintain the ability to work well with others in a variety of situations
• Must be able to multi-task, work under time constraints, problem solve, and prioritize
• Ability to make independent and sound judgments
• Demonstrates enthusiasm, takes accountability, and drives for results.
• Superior organizational and leadership skills with ability to help team grow and thrive
• Able to lead and front multiple third party Medical Device / Pharmaceutical audits.
• Able to interact with global Medical Device / Pharmaceutical agencies in support of queries / product launches.
• Have in-depth / working knowledge of: ISO 13485, US FDA 21 CFR Part 820, ISO14971
• Have strong self-motivation, the ability to work independently, and within a team environment with strong follow up, organization and prioritization skills and excellent attention. Must have a proven track record of developing and maintaining positive customer relationships.
• Able to lead and manage the performance of a multi-functional team.
• Able to organize and prioritise tasks, must be detail orientated and self-motivated.
• Have excellent written and verbal communication skills. Must be able to work in a fast paced environment.
• Able to be aware of all relevant SOPs as per Company policy as they are related to the position covered by this Job Description
• Able to always comply with the company’s safety and quality policy

• Interacts with all departments pertaining to implementation of statistically established studies either for process improvements or establishment thereof.
• Ensure quality of all materials used in the process by developing and implementing effective reliable testing techniques.
• Ensure continued reliability of testing techniques by maintaining current knowledge of all technical and analytical information.
• Write technical reports as required to defend or support decisions concerning material acceptability.
• Establish and implement reliable procedures to ensure compliance with good manufacturing practices.
• Provide project leadership for materials / process related projects by coordinating the efforts of the various departmental disciplines for the successful completion according to plan and budget.
• Support the efforts of production in materials related areas as a technical advisor.
• Reviews data using InTouch and eDart software, for investigation of problems.
• Take appropriate action to ensure compliance with all safety, health and hazardous communication standards.
• Ensures that established policies, rules and regulations, and procedures are followed.
• Actively participate and comply with all West HSE programs and regulations.
• Maintain a neat and orderly work environment in accordance with West 6S program.
• Other duties as assigned.

• Associate or Bachelor’s Degree or equivalent on the job experience in a technical discipline to include manufacturing, industrial, materials or plastics.

• Experience: 3-5 years of job-related experience
• Knowledge of the basic principles of injection molding, systematic molding, mold design, mold assembly, and machine operations.

• Must have excellent interpersonal & problem-solving skills & be able to interface with employees at all levels of the organization; must possess good organization, time-management, negotiating & conflict resolution skills.
• Must be familiar with computers and various software programs.
• Familiarity with SAP, Master Control or similar systems and databases, a plus.
• Knowledge of statistical tools and Minitab.

• Able to be aware of all relevant standard operating procedures as per Company policy as they are related to the position covered by this Job Description
• Support and contribute to Lean Sigma programs and activities towards delivery of the set target.
• Able to comply with the company’s safety policy at all times.
• Able to comply with the company’s quality policy at all times.

• Manufacturing\Six Sigma Green Belt Certification preferred

• While performing the duties of this job, the employee is regularly required to, sit, stand, walk, talk, hear, see and use hands and fingers to operate office equipment (ie phones, computers, copies, etc.).
• Sitting and/or standing for extended periods may occur as well as getting to and from offices and building sites.
• The ability to be able to lift and carry various items up to 40 pounds.
• The employee is occasionally exposed to wet and/or humid conditions and fumes or airborne particles.
• The employee occasionally works near moving mechanical parts and or equipment.
• The employee occasionally works in clean room environments requiring special gowning and training to operate in these environments.
• The noise level in the office work environment is usually quiet. The noise level in the manufacturing work environment is moderate to loud. Hearing protection is required as posted in the manufacturing work environment.
• Job requires mental skill or ability such as communication, decision making (sometimes quick), interpreting data, reading, or writing, organization, problem solving, understand direction, etc.

Responsible for providing expertise in Quality Assurance processes related to the manufacture of West products. Ensure compliance with regulatory requirements and West procedures. Proactively develop, lead, and drive the execution of the Quality Assurance strategy. Develop and implement quality assurance plans ensuring compliance with regulations, oversee interactions with regulatory agencies and build strong relationships with internal and external stakeholders. Champion advocacy for product, process, and system quality, and drive continuous improvement within the Quality Management System.

• Reporting to the Sr. Director, Quality Assurance, the role will play a critical part in the company’s business planning / strategy development.
• As a member of the Site Leadership Team, deeply engages and effectively contributes to the achievement of site objectives by playing an active role in the strategic planning processes
• The role will also have a dotted line reporting relationship to the Director, Operations, Williamsport to ensure development and alignment of the site business plan including support to the other senior managers in the execution of same
• Maintain a positive working relationship with internal and external stakeholders by supporting validation in design and development, specification development, and execution of manufacturing programs in line with agreed standards. All the while ensuring that West’s product quality and reliability meets or exceeds customers’ expectations.
• Directs and manages quality control, quality assurance, quality systems, metrology and/or regulatory affairs, personnel, department resources, and continuous improvement efforts to achieve the most efficient quality output possible.
• Partner with organizational leaders and drive quality initiatives, systems, and methods to meet quality objectives. Meet company and departmental goals in the continuous improvement of all products, services, and processes, including the West QMS. Support QMS activities including CAPA, Failure Investigation, Non-Conformance assessment, and audit findings.
• Perform the necessary functions in support of the Williamsport Quality System
  • Designated ISO 13485 Management Representative
  • Designated back-up to QA Supervisor for HACCP Manager and SQF Practitioner.
• In accordance with US and other regional/ country legislation, act as Head of Quality Control/ Head of Quality/ Official Correspondent on all government agency issued authorizations, communications and registrations.
• Cultivate a positive working relationship with the West Customer base via supporting validation in design and development, agreeing specification, execution of manufacturing and programs in line with agreed standards. All the while ensuring that the West’s product quality and reliability meets or exceeds customers’ expectations
• QA representative participating in customer face to face steering committees and business review which originate from site customer base. Chairing customer meetings with respect to Quality standards and expectations.
• Champion a quality/ patient first organizational culture that promotes behaviors that lead to superior quality and business performance and enterprise excellence.
• Participate in customer, regulatory, and internal audits of the plant; participate in supplier audits and participate as part of the Corporate Cross Site Audit Team.
• Review and assist on the updating of customer specifications. Respond to customer/sales regarding the approval or recommended changes to these specifications and maintain a file of the responses and the specifications.
• Oversees complaint handling, non-conformance management, internal and external audits, and CAPA system to ensure timely and compliant systems. Evaluates and provides for audits of external and internal quality systems and their functions, insuring follow through and corrective actions.
• Establish, monitors, and provides weekly / monthly progress of the Quality KPIs and communicate it to the organization and senior management.
• Responsible and accountable for quality departmental budget
• Other duties as assigned

• Bachelor's Degree in engineering, mechanical engineering, chemical engineering, manufacturing engineering, industrial engineering or equivalent experience required
• Master’s degree preferred

• 10+ Years of job-related experience required in the Medical Device or Pharmaceutical Industry.
• 8+ Years of supervisory experience required.
• 5+ Years of experience working with injection molding processes preferred.
• 5+ Years of experience in an FDA or ISO regulated industry required, preferably in medical device manufacturing.

• Regulatory Skills: In-depth knowledge of medical device and pharmaceutical regulations and guidelines, including cGMP, ICH guidelines and other relevant regulatory requirements (e.g. HACCP).
• Leadership Skills: Strong leadership and management skills with the ability to lead cross-functional teams, drive initiatives, and influence stakeholders at all levels of the organization.
• Communication Skills: Excellent communication skills, both written and verbal, with the ability to effectively communicate requirements and strategies to diverse audiences.
• Analytical Skills: Strong analytical and problem-solving skills, with the ability to analyze complex problems, identify root causes, and develop effective solutions.
• Adaptability: Flexibility and adaptability to navigate changing regulatory landscapes and business priorities.
• Ethical Standards : Adherence to ethical standards and integrity in dealing with regulatory agencies, colleagues, and stakeholders.
• Self-motivated with a proactive attitude and the ability to work effectively
• Project Management experience preferred

• Excellent communication and interpersonal skills must be coupled with public speaking, quick decision making.
• Excellent written and oral communication skills
• Medical component and device manufacturing require strict adherence to standards.
• Strong communication and technical writing skills, interpretation of data, interpersonal skills, ability to work on and lead teams
• Read and interpret data, information, and documents
• Must maintain the ability to work well with others in a variety of situations
• Must be able to multi-task, work under time constraints, problem solve, and prioritize
• Ability to make independent and sound judgments
• Demonstrates enthusiasm, takes accountability, and drives for results.
• Superior organizational and leadership skills with ability to help team grow and thrive
• Able to lead and front multiple third party Medical Device / Pharmaceutical audits.
• Able to interact with global Medical Device / Pharmaceutical agencies in support of queries / product launches.
• Have in-depth / working knowledge of: ISO 13485, US FDA 21 CFR Part 820, ISO14971
• Have strong self-motivation, the ability to work independently, and within a team environment with strong follow up, organization and prioritization skills and excellent attention. Must have a proven track record of developing and maintaining positive customer relationships.
• Able to lead and manage the performance of a multi-functional team.
• Able to organize and prioritise tasks, must be detail orientated and self-motivated.
• Have excellent written and verbal communication skills. Must be able to work in a fast paced environment.
• Able to be aware of all relevant SOPs as per Company policy as they are related to the position covered by this Job Description
• Able to always comply with the company’s safety and quality policy

This role will require you to develop strategic plans for maturing the lean culture and efficiency within the site and West. You’ll provide leadership, influence and team development on lean thinking and lean processes at all levels in the organization. You will distill and work across the site to implement the West Business System. You will govern site lean savings, goals and objectives. You will lead site wide efficiency projects. A strong desire to engage teams across all levels and implement improvements assures that you are a good fit for the role.

• • Develop robust, capable systems necessary to achieve the strategic goals and objectives and drive excellence through the manufacturing operations; assure that production processes are repeatable and capable of meeting specifications, by ensuring the consistent and uniform application of OPEX tools.
  • Create and manage strategic plans to eliminate waste within the business unit by utilizing lean processes, key performance indicators, metrics, cost savings, best demonstrated practices and enterprise resource management.
  • Working with site teams identify annual site savings, manage the tracking, validation and communication of savings. Ensuring contingency plans are implemented for at risk projects.
  • Working with the Site Leadership and operations teams develop robust Lean Daily Management systems including leader standard work, Tiered meetings, daily Gemba’s
  • Participate in the development and implementation of the West Business System (WBS) on site, working with stakeholders to sustain and improve operational standards on the site.
  • Organize and embed the Operational Excellence systems (Kaizens, 5S events, Gemba’s, Lean programs, GB/BB projects and certifications, LDMS, Maturity model, Etc.)
  • Provide leadership on lean thinking and lean processes to ensure established goals and objectives are met and provide methods to monitor processes to assure they remain in control.
  • Organize and/or assist in the training and guidance for lean champions and team members to develop and implement Lean action plans and transfer lean initiatives to other West plants.
  • Sets up and/or participates in continuous improvement events related to establishing a process or process improvement.
  • Manage the continuous improvement of the West Kaizen program.
  • Work with all departments to develop and maintain meaningful lean metrics, status update reporting, and documentation of identified and implemented projects.
  • Work with the relevant stakeholders on new business implementation – facilitating value stream mapping, material flow modelling and layout review.
  • Network, assist and support lean efforts and best practices across the organization through participating in events and sharing of documentation and improvements.
  • Continuous updating and development of lean implementation plans and strategic future stream maps.
  • Other duties as assigned

• Bachelor’s degree in Engineering, Business or Statistics concentration; or recognized equivalent
• Master’s degree is preferred.

• 10+ years’ experience in a manufacturing/production environment
• Must possess a Six Sigma Green Belt certification and have at least 5 years of experience demonstrating and using Six Sigma/Lean tools and methodologies.
• Medical Device industry experience preferred.

• • Must have good interpersonal/leadership/influential skills and be able to interface with all departments and team member levels.
  • Must have excellent organizational, interpersonal and problem-solving skills and be able to interface with employees in all levels of the organization.
  • Excellent computer skills required including SAP, all MS Office applications, Mini-tab and other statistical software programs.
  • Able to be aware of all relevant SOPs as per Company policy as they are related to the position covered by this Job Description
  • Work closely with other functions to maximize achievement through a cooperative environment
  • Support and contribute to Lean Sigma programs and activities towards delivery of the set target
  • Able to comply with the company’s safety policy at all times
  • Able to comply with the company’s quality policy at all times.

• Manufacturing\Six Sigma Green Belt Certification Upon Hire required and
• Health Services\CSSBB - Six Sigma Black Belt Upon Hire preferred

• Safely work in construction environments
• Noise level in the work environment while on the production floor is usually moderate to loud. Hearing protection is required.
• Must follow and comply with Plant’s Dress and Hygiene Code (SOI)

• Champion a culture of health and safety in accordance with the highest standards of regulatory compliance.
• End to end ownership for the full business value stream.
• Build and maintain an excellent working relationship with the customer in the successful delivery of all client related projects (on time, within budget and in accordance with customer requirements/specifications).
• Support the Customer Account Manager in developing and executing a compelling strategic sales / business plan for the continued growth of the Value Stream
• Commercial leadership and management of Value Stream customers, including full operational P&L responsibility.
• Lead and drive the highest standards in Operational performance, 6S, people development to build on the culture of continuous improvement and growth, to deliver tangibly high quality performance outcomes
• Drive excellent cross functional relationships both within the Value Stream and companywide.
• Demonstrate excellent leadership visibility to drive engagement levels across the organisation.
• Development of the team to support Value Stream and performance and growth, including the recruitment, identification, development and retention of talent in the Value Stream.
• Strong coaching / development of team using development and retention plans as appropriate.
• Other duties assigned.

• Education: Bachelor's in a technical discipline to include: Business, Operations or Engineering.

• Experience: 8-10 years of experience in leading and managing a diverse team in a fast paced and highly regulated environment.
• 3+ years’ experience of working in medical devices sector or similar is an advantage.
• Ideally have injection molding and tooling knowledge / expertise.

• General knowledge of OSHA/EPA/safety regulations, manufacturing and process automation.
• Working knowledge of business and shop floor systems to effectively manage operations; prefer SAP and MS Office applications.
• Experience working with ISO9000, FDA and cGMP required.
• Ability to read and interpret documents and drawings, specifications, safety rules, operating instructions, procedure manuals and regulatory documentation.
• Ability to write routine reports, correspondence and process documents.
• Ability to speak effectively before groups and employees in the organization.
• Write monthly progress reports and capital request.
• Able to be aware of all relevant SOPs as per Company policy as they are related to the position covered by this job description.
• Support and contribute in Lean Sigma programs and activities towards delivery of the set target
• Able to comply with the company’s safety policy at all times.
• Able to comply with the company’s quality policy at all times.

• Medical Device manufacturing requires strict adherence to standards. Working environment is a manufacturing facility, which houses plastic injection molding machines. Must tolerate fumes and particulate generated from various plastics. Work areas are equipped with adequate lighting, cooling/heating and equipment that are in a good working condition. Must work constructively in an environment that may be stressful due to competing resources while at all times maintaining company confidentiality.
• May stand or sit for extended periods of time. Must transport oneself to and from other areas of the facility and travel to other divisions when necessary. Must have good visual acuity. If specifically necessitated by customer requirements, must be able to see with or without corrective lenses and distinguish color differences for product and safety issues. Hearing ability should be sufficient to hear audible alarms from distances up to 150ft.
• The ability to be able to lift and carry various items up to 50lbs.
• Minimal travel

The Process Technician is responsible for safely implementing, optimizing, and sustaining injection molding processes, molds, and equipment to consistently produce high-quality products for our customers. The role requires strict adherence to all safety, and processing protocols. The Process Technician must maintain a clean and safe work environment per the West 6S program, perform regular preventative maintenance, and assume material handling duties as needed. Additional responsibilities may be assigned to support operational objectives.

• Maintain the injection molding process definition for all jobs.
• Utilize statistical analysis of process data, along with troubleshooting techniques, to redefine and improve processes that fail to meet established product criteria.
• Properly document corrective actions using Good Documentation Practice standards (GDP).
• Ensures that established policies, rules, regulations, and procedures are followed.
• Effectively communicates between all departments.
• Safely and properly installs tooling and applicable auxiliary equipment.
• Completes all prerequisite tasks and documentation for starting a production tool.
• Effectively perform scheduled preventative maintenance of tools and equipment.
• Actively participate and comply with all West Health Safety Environment (HSE) programs and regulations.
• Support and contribute to Lean Sigma programs and activities towards delivery of the set target.
• Compliance with the company’s quality policy at all times.
• Additional duties as assigned.

• High School Diploma or GED required

• Minimum 3 years experience in a mechanical related field.
• Preferred: Minimum 3 years of injection molding – machine start up and shut down – mold pull / set activities – Setup and operation of 3 axis robots.

• Ability to analyze details and strong problem-solving abilities.
• Strong communication and teamwork skills.
• Ability to interpret and apply work instructions.
• Ability to obtain a Powered Industrial Truck (PIT) license.
• Ability to read mechanical diagrams and schematics.
• Ability to read and interpret technical drawings, blueprints, and process control documentation.
• Possess a fundamental mechanical aptitude of mechanical principles and concepts.
• Proficient with Microsoft Office.
• Demonstrated ability to perform root cause analysis to identify and address underlying issues in production processes, improving efficiency and product quality.

Coordinate planning and execution of all processing needs and issues. Direct and coordinate activities of the technicians. Communicate with Area Manager, Manufacturing Supervisor and/or Supervisory Designee

• Coordinate technical activities for the shift to include monitoring of quality, human resource allocation, supply and housekeeping.
• Plan daily activities of technical group and communicate processing concerns that will influence the daily schedule to management.
• Gathering of valid production data and reporting to management.
• Creation and maintenance of a positive work environment.
• Training of employees on Process Monitoring Systems or other information systems.
• Coordinates activities of shift technical group to include process implementation, process maintenance, designs of process, capability studies and housekeeping.
• Maintains pertinent files on processes necessary for future referral.
• Institutes and ensures implementation of training programs to ensure personnel are proficient in performance of assigned duties.
• Takes appropriate action to ensure compliance with all safety, health and hazardous communication standards.
• Ensures that established company policies, rules, regulations, and procedures are followed.
• Training and certification on related employee procedures.
• Support of management decisions.
• Actively participate and comply with all West HSE programs and regulations.
• Maintain a neat and orderly work environment in accordance with West 6S program.
• Other duties as assigned.

• Bachelor’s degree in Engineering in manufacturing, industrial, materials or plastics or
• Associates degree in Engineering in manufacturing, industrial, materials or plastics with a minimum of five (5) years of hands on experience in a manufacturing environment.

• 10 years of hands on experience in a technical supervisory role in a manufacturing environment, preferably plastic injection molding industry.
• 2-3 years of leadership experience. required
• Knowledge of the basic principles of injection molding, systematic molding, mold design, mold assembly, and machine operations.

• Must be familiar with computers and various software programs.
• Familiarity with SAP, Master Control or similar systems and databases, a plus.
• Excellent communication and interpersonal skills.
• Good analytical skills.
• Ability to work both independently with little direction, and as a member of a team.
• Ability to manage several projects at once to meet established timelines is essential.
• Ability to read electrical, mechanical, and hydraulic/pneumatic drawings is essential
• Some understanding of the injection molding process

• While performing the duties of this job, the employee is regularly required to, sit, stand, walk, talk, hear, see and use hands and finger to operate office equipment (ie phones, computers, copies, etc.).
• Sitting and/or standing for extended periods may occur as well as getting to and from offices and building sites.
• The ability to be able to lift and carry various items up to 40 pounds.
• The employee is occasionally exposed to wet and/or humid conditions and fumes or airborne particles.
• The employee occasionally works near moving mechanical parts and or equipment.
• The noise level in the office work environment is usually quiet. The noise level in the manufacturing work environment is moderate to loud. Hearing protection is required at all times in the manufacturing work environment.
• Job requires mental skill or ability such as communication, decision making (sometimes quick), interpreting data, reading or writing, organization, problem solving, understand direction, supervise and speak publicly, etc.