Sr Manufacturing Engineer jobs at West Pharma

• Initiate, lead and coordinate improvements of existing processes globally on quality, service, HSE and cost within the standard known/approved process frame and using best practice knowledge
• Strongly support the implementation / roll-out of automation and new innovative processes and technologies in joint cooperation with the automation, engineering- and quality assurance teams and the plants.
• Manage the development of robust process for final industrial production in targeted plants.
• Assess current process status in all relevant West locations globally, define best practices, perform a gap analysis and manage the harmonization of this best practice to all sites involved.
• Engage in solutioning product or process related issues as needed.
• Support the introduction, start-up and validation of new equipment in the local sites.
• Support process or technology or product transfer projects between plants from a process stand-point.
• Evaluate and approve all change requests globally.
• Utilize six sigma tools in minimizing process variation and improving the quality of product produced.

• Bachelor's or Master's Degree in Engineering or another scientific area or equivalent experience required

• Minimum 3 years experience in a similar position within the manufacturing industry required
• Experience in Project Management preferred

• Good knowledge of LEAN and Six Sigma manufacturing principles (Green Belt certification)
• Knowledge of MS Office, statistical tools and Minitab
• cGMP knowledge
• Fluent English and German skills
• Self motivated, result- and solution-oriented personality
• Excellent communication skills
• Ability to successfully collaborate with teams across different countries and organizational levels

In this role you will coordinate business unit lean savings, goals and objectives through the use of statistical techniques by planning, scheduling, and executing process projects. You will communicate project status, and define and shape strategic planning efforts, including critical goal and objective development that identifies and improves critical processes necessary to achieve annual targets, including waste reduction to drive technical and operational improvement. This role will focus on coordinating, managing, and driving all transformation initiatives across site, ensuring alignment with both site’s and operational goals and the corporate stakeholders’ broader strategic objectives.

• Oversee the planning, execution, and delivery of all transformation projects, ensuring they are completed on time, with scope and within budget.
• Establish clear metrics and KPI’s for each transformation initiative, regularly tracking and reporting on progress to SLT and key stakeholders.
• Participate in the development and support of the West Business System (WBS), with the goal of sustaining operational standards on the site.
• Develop and communicate a comprehensive transformation strategy that aligns with the site growth targets, technical & operational capability imperatives, operational excellence objectives and the Operating Units vision.
• Provide thought leadership and direction for all transformation activities, ensuring they are prioritized, scheduled, and executed effectively.
• Create 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.
• Create and execute a robust change management framework that prepares the site and its employees for upcoming changes, minimizes resistance, and maximizes adoption of new processes and technologies.
• Ensures that all transformation initiatives are supported by effective communication plans that keep all stakeholders informed and engaged.
• 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.
• 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.
• 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.

• Bachelor’s in engineering, Statistics or recognized equivalent required
• Master’s Degree in related field preferred

• Minimum 10 years (Sr Mgr) in related field required
• At least 5 years of experience in a manufacturing/production environment required
• 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 required
• Medical Device industry experience preferred

• Must have good interpersonal/leadership 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 at all levels of the organization.
• 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.

• 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)

• Provide engineering assistance to assure plant, machinery and processes are at an optimum level.
• Demonstrated experience in Metal Stamping and Progressive Die industry.
• Ensure plant is in compliance with OSHA and local, state and federal environmental regulations.
• Assist in Writing validation, user requirements, equipment specification and other documents as needed.
• Promote and support a Lean Manufacturing environment within the facility.
• Assist in process and procedure improvements to manufacture a quality product at a minimum cost.
• Assists in quoting new tooling/dies, engineering services, automation, etc. for new and existing customers. Helps Develop suppliers and maintain audit. Develops design concepts for new molds.
• Purchases tooling related equipment in accordance with the company policy.
• Provides a “Customer Service” attitude when interacting with internal and external customers while accomplishing work, production, and achieving quality standards.
• Maintain machine and plant equipment drawing for the Tool Room.
• Support in Developing initial project scope, timeline, savings and cost estimations.
• Write CER and project justification documents.
• Support in Developing equipment requirements.
• Research new technologies and methodologies to use in the plant.
• Present justification to management and/or customer to attain approvals.

• Performs other duties, as assigned based on business needs.
• Conforms with and abides by all regulations, policies, work procedures, instruction, and all safety rules.
• Exhibits regular, reliable, punctual and predictable attendance.

• Bachelor's Degree in Mechanical Engineering, Manufacturing Engineering, or equivalent experience required

• Minimum 3 years of relevant experience. Prior manufacturing experience in an industrial setting (pharmaceutical industry experience preferred). required
• Advanced in using SolidWorks. required
• Excellent computer skills required including all MS Office applications. required

• Good understanding in machining and fabrication equipment and methods (e.g. milling, turning, grinding, eroding, etc.).
• Familiar with cGMP, ISO, and FDA standards.
• Familiar with AutoCAD, Finite Element Analysis, Computational Fluid Dynamics, and PDM Pro.
• 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 and quality policies at all times

• Must be able to negotiate and effectively resolve conflicts when required
• Able to routinely use standard office equipment such as computers, phones, photocopiers, filing cabinets and fax machines. Position operates in a professional office environment. May stand or sit for extended periods of time
• Must be able to communicate effectively with written and oral skills, make quick decisions, interpret data, read and write, speak in front of groups, express and exchange ideas, understand direction and adhere to procedures
• Organizational skills will enable planning, prioritization and achievement of goals especially of importance for the successful execution of related activities
• Read and interpret data, information and documents
• Ability to quickly adapt to changes in a dynamic environment and must maintain the ability to work well with others in a variety of situations
• Effective personal time management skills. Must be able to multi-task, work under time constraints, problem solve, and prioritize
• Ability to make independent and sound judgments
• Observe and interpret situations, analyze and solve problems
• Must be able to speak English fluently

• 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.

• Lead project planning activity and develop comprehensive project plans including scope, timelines, budget, resources, and project success criteria. Gain buy-in from project team and ensure an inclusive approach to project planning. Proactively identify gaps and risks to project success and implement mitigation strategies to minimize impact.
• Collaborate with cross-functional teams, internal and external to the laboratory, to coordinate project execution and ensure that project objectives and success criteria are met.
• Provide Quality Engineering direction to multiple concurrent product development programs to ensure product and process compliance to all applicable regulatory and cGMP requirements, including ensuring all relevant safety procedures are employed.
• Author, review, and/or approve design history documentation and design manufacturing documentation (e.g., product specifications, design verification and validation activities, FMEA risk documents, test methods, protocols, reports, manufacturing records, etc.)
• Lead the development and maintenance of product or process risk and hazard analysis in accordance with West policies and procedures and ISO standards.
• Lead and manage QMS activities including CAPA, Failure Investigation, Non-Conformance assessment, audit findings, issue reviews, document control, change controls, configuration management, etc. Provide direction on any nonconformance, deviation, or excursion that may occur and drive to closure. Author and review product development QMS procedures and work instructions.
• Meet company and departmental goals in the continuous improvement of all products, services and processes, including the West QMS.
• May work independently and with project teams to develop design control deliverables including quality plans, manufacturing and inspection documentation, test methods, and any other necessary quality records. Provide quality reports and review trending on assigned areas of responsibility.
• May support quality assurance improvement activities by evaluating products, processes or materials in order to develop control or improvement strategies intended to improve the customer’s experience.
• May assumes responsibility for various assigned projects designed to improve product quality, reduce costs and/or validate facility products or processes, including development and implementation of any new or required inspection methods and in-process Statistical Process Control programs.
• May perform DOEs (Design of Experiments) to help improve and optimize new and/or existing plant processes or job protocols, and identify and remedy equipment and/or process documentation gaps and provide appropriate training where needed.
• May have people management responsibilities.
• Other duties as assigned.

• Bachelor's Degree in Engineering or Science or equivalent experience required

• Minimum 5 years of experience in a regulated industry (e.g., Medical Device), including Product Development, Product Manufacturing, and Post Market Surveillance Activities required and
• Demonstrated experience (4+ years) independently defining, planning, and executing projects in highly regulated environments with a track record of success required and
• In-depth knowledge of cGMP regulations, ISO 17025, ISO 11040, ISO 13485, 21 CFR 820, ISO 14971 required and
• Proficiency in standard project management tools and software (e.g. Microsoft Project, Excel) for planning, tracking, and reporting project activities, and proficient in statistical software, Windows OS, Microsoft Office Suite including Word, Excel, and Power Point required and

• Experience with MasterControl, SAP, Share Point, Teamcenter
• Experience with ISO 11040, ISO 11607
• Expertise in quality management tools. Standards, policies, and procedures – APQP, PPAP, MSA, SQC etc
• Strong working knowledge of quality systems of the respective ISO norms
• Working knowledge of supplier quality management from product development to mass production.
• Strong project management skills
• Proficient in computer system applications (SAP, master controls, etc) communication skills
• Excellent critical reading and writing skills
• Problem solving including root cause failure analysis methods
• Be aware of all relevant SOPs as per Company policy as they relate to this role
• Able to comply with the company’s safety and quality policies at all times

• Exhibit a strong “quality first” mentality and ensure that product and process quality are held to the highest standard.
• Excellent written and oral communication and interpersonal abilities, with the capacity to communicate complex technical concepts to diverse stakeholders.
• Ability to work independently, multi-task and thrive in fast-paced environment.
• Strong problem-solving skills including root cause failure analysis methods.
• Adaptable to changes in the work environment, manage competing demands and deal with frequent change, delays or unexpected events.
• Must maintain the ability to work well with others in a variety of situations.
• Critical reading skills and maintain high attention to detail, accuracy, and overall quality of work.
• Must be able to multi-task, work under time constraints, problem solve, and prioritize.
• Ability to make independent and sound judgments.
• Observe and interpret situations, analyze and solve problems.

• Manufacturing\Six Sigma Green Belt Certification or Black Belt Upon Hire preferred
• Quality\Certified Quality Technician-ASQ (CQE or CQA) Upon Hire preferred
• SO 17025 Auditor or Lead Auditor Training / Certification Upon Hire preferred

• Mentor and may lead engineering team to achieve site and department goals in a fast-paced environment.
• Collaborate with cross-functional teams to develop and implement sustainable manufacturing processes and systems.
• Technical and hands-on automated equipment troubleshooting, repair, and improvements.
• Perform and document engineering studies and evaluations.
• Analyze data to drive improvements, determine prioritization, and identify opportunities.
• Lead and provide mentorship in root cause and corrective action (RCCA).
• Assess and perform/schedule technical training, including electromechanical systems, pneumatics, servos, PLCs, schematic reading/interpretation, new technology, etc.
• Champion high-visibility projects. Develop project scope, timeline, savings, and cost estimations.
• Quote new automation lines, engineering services, etc. Develop design concepts for new automation.
• Write validation, user requirements, equipment specification, and other documents as needed.
• Establishes relationships with customer and automation suppliers in pursuit of win?win results and ongoing business.
• Provide engineering assistance to assure plant, machinery, and processes are at an optimum level.
• Routinely evaluate and review employee performance.
• Promote and support a Lean Manufacturing environment within the facility.
• Research new technologies and methodologies to use in the plant.
• Provide a “Customer Service” attitude when interacting with internal and external customers while accomplishing work, production, and achieving quality standards.
• Perform other duties as assigned based on business needs.
• Conform with and abides by all regulations, policies, work procedures, instruction, and all safety rules.
• Exhibit regular, reliable, punctual and predictable attendance.
• Other duties as assigned.

• Bachelor's Degree In Engineering or Science field required
• Master's Degree In Engineering or Science field preferred

• Minimum 5 years 5-8 years of experience required and
• 2+ years of managerial or supervisory experience in manufacturing environment required and
• Strong automation background and experience with CAD and SAP systems a plus. preferred

• Knowledge of manufacturing processes, workflows, production equipment and industrial techniques.
• Must have effective problem solving and interpersonal skills.

• Manufacturing\Six Sigma Green Belt Certification Six Sigma green belt Upon Hire preferred or
• Manufacturing\Lean Six Sigma Black Belt Six Sigma black belt Upon Hire preferred

• Must be able to perform job duties as required with limited physical demands.

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