דרושים Tooling Engineer Technician ב-West Pharma ב-United States, Williamsport

• 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.

In this role, you will be responsible for performing highly diversified duties to install, troubleshoot, repair and maintain production equipment according to safety, predictive, and productive maintenance systems and processes to support the achievement of the site’s business goals and objectives.

• Provide emergency/unscheduled repairs of all manufacturing equipment during production as well as performing scheduled preventative maintenance of the same.
• Perform mechanic skills including, but not limited to, mechanical, electrical, pneumatic, hydraulic, troubleshooting and repair of production machines.
• Maintains and updates equipment documentation regarding repair/adjustments.
• Be able to comprehend equipment manuals, electrical wiring diagrams, hydraulic drawings, and mechanical drawings.
• Be able to provide required fabrication of various shields and guards. Ability to bend, cut, shape, weld.
• Diagnose problems, replace or repair parts, test, and adjust.
• Interface with manufacturing engineering to implement process improvements.
• Use a variety of hand and power tools, electric meters and material handling equipment in the performance of your duties.
• Be available to work various shifts, including overtime and weekends when necessary. To share call in duties with others assigned.
• Actively participate and comply with all West Health, Safety and Environmental programs and regulations.
• Maintain a neat and orderly work environment in accordance with West 5S program.
• Participate in training to become more proficient in the working knowledge of and repair of incoming machinery.
• Set up and installation of incoming and new equipment.
• Other duties as assigned.

• High School Diploma or GED Required.
• Trade or Vocational School preferred.
  • One (1) year certificate from a technical school or college in a trade relating to electrical, pneumatic or mechanical; or a minimum of 3 years’ experience on the job training (related to plant maintenance); or a combination of education and experience in a trade relating to this position.

• 3 years of manufacturing maintenance experience or a combination of education and experience in a trade relating to this position.

• Ability to operate a Powered Industrial Truck.
• Ability to understand and follow company's Standard Operating Procedures.
• 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.

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

• Assist in making necessary repairs and adjustments to machines and systems to ensure highest possible quality while maintaining lowest reject rate possible.
• Follow engineering department guidelines and procedures.
• Assist in performing changeovers and setups on systems and make minor adjustments as necessary.
• Have an understanding operation and set up and be able to maintain repair and a variety of machinery with the assistance of a trainer.
• Learn and perform preventative maintenance as required on schedule.
• Complete necessary production records and requisitions for materials and supplies.
• Interface with lead and purchasing/receiving coordinator with spare parts and material concerns.
• Support process improvement efforts and perform related duties.
• Conforms with and abides by all regulations, policies, work procedures, instruction, and safety rules.
• Analyzes and resolves work problems and assists workers in solving work problems.
• Participate in validation activities as needed.
• Must observe good housekeeping practices.
• Participate in validation activities as needed.
• Exhibits regular, reliable, punctual and predictable attendance.
• Performs other duties as required and/or assigned.

• High School Diploma or GED required

• Minimum 3 years of experience in operating drill press, band saws, hand tools and grinding/abrasive tools with a mechanical / electrical background required. Vocational program / Trade School training may be substituted for experience.

• Ability to read mechanical diagrams and schematics.

Schedule-12 hour night shift 5:45p-6am

In this role, you will perform a variety of tasks and conducts test procedures in regard to the quality process, ensuring that the pre-determined high standards of quality are achieved and maintained.

• Review and approval of metrology reports, where appropriate, for batch release and validation purposes
• New product validation, analysis and reporting.
• Quality support to Engineering and Production Departments.
• Establish and maintain documentation in line with West Williamsport and West Pharmaceutical Services Quality Systems.
• Liaise with customers and suppliers on new and existing projects.
• Receiving and inspection of incoming goods and materials.
• Ensure that all parts/ materials, which require incoming inspection, conform to all requirements and applicable drawings and specifications.
• Maintain good communications both internally and externally.
• Ensures that all metrology equipment is correctly calibrated.
• Assists shift personnel with quality issues and/or measurement techniques.
• Assists in problem resolution with customers.
• Perform periodic audits as requested and completes necessary documentation.
• Archives quality records, samples and log procedures.
• Makes periodic clean-out of records and samples exceeding minimum retention requirements as per West procedures.
• Batch paperwork review and final decision to release product for shipment.

• Provide a “Customer Service” attitude when interacting with internal and external customers while accomplishing work, production, and achieving quality standards.
• Maintain a clean, orderly, and safe workstation and environment at all times.
• Conform with and abide by all regulations, policies, work procedures, instruction, and safety rules.
• Exhibit regular, reliable, and punctual attendance.
• Perform other duties as assigned based on business needs.
• Keep current with new GMP compliance guidance and internal QA procedures
• Support new GMP compliance guidance and Data Integrity initiatives

• High School Diploma or GED Required.
• Preferred Associates degree in Metrology or QA; or 3 years’ on the job experience in a plastics manufacturing environment

• 3 years of job-related experience; in QA/QC and the use of measuring equipment.

• Able to be aware of all relevant standard operating procedures as per Company policy
• Support and contribute to Lean Sigma programs and activities towards delivery of the set target
• Possess ability to work independently and as part of a team with self-motivation, adaptability, and a positive attitude
• Willingness to learn new and review new analytical techniques
• Meet individual and departmental goals as required

• Ability to learn, understand, and remember normal tasks.
• Ability to hear, speak, and understand conversation in English in a normal tone of voice.
• 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.
• Read and interpret data, information and documents
• Work under deadlines with constant interruptions

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.

Schedule- 12 hour day shift

In this role, you will perform a variety of tasks and conducts test procedures in regard to the quality process, ensuring that the pre-determined high standards of quality are achieved and maintained.

• Review and approval of metrology reports, where appropriate, for batch release and validation purposes
• New product validation, analysis and reporting.
• Quality support to Engineering and Production Departments.
• Establish and maintain documentation in line with West Williamsport and West Pharmaceutical Services Quality Systems.
• Liaise with customers and suppliers on new and existing projects.
• Receiving and inspection of incoming goods and materials.
• Ensure that all parts/ materials, which require incoming inspection, conform to all requirements and applicable drawings and specifications.
• Maintain good communications both internally and externally.
• Ensures that all metrology equipment is correctly calibrated.
• Assists shift personnel with quality issues and/or measurement techniques.
• Assists in problem resolution with customers.
• Perform periodic audits as requested and completes necessary documentation.
• Archives quality records, samples and log procedures.
• Makes periodic clean-out of records and samples exceeding minimum retention requirements as per West procedures.
• Batch paperwork review and final decision to release product for shipment.

• Provide a “Customer Service” attitude when interacting with internal and external customers while accomplishing work, production, and achieving quality standards.
• Maintain a clean, orderly, and safe workstation and environment at all times.
• Conform with and abide by all regulations, policies, work procedures, instruction, and safety rules.
• Exhibit regular, reliable, and punctual attendance.
• Perform other duties as assigned based on business needs.
• Keep current with new GMP compliance guidance and internal QA procedures
• Support new GMP compliance guidance and Data Integrity initiatives

• High School Diploma or GED Required
• Preferred Associates degree in Metrology or QA; or 3 years’ on the job experience in a plastics manufacturing environment

• 3 years of job-related experience; in QA/QC and the use of measuring equipment.

• Able to be aware of all relevant standard operating procedures as per Company policy
• Support and contribute to Lean Sigma programs and activities towards delivery of the set target
• Possess ability to work independently and as part of a team with self-motivation, adaptability, and a positive attitude
• Willingness to learn new and review new analytical techniques
• Meet individual and departmental goals as required

• Ability to learn, understand, and remember normal tasks.
• Ability to hear, speak, and understand conversation in English in a normal tone of voice.
• 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.
• Read and interpret data, information and documents
• Work under deadlines with constant interruptions