West Pharma Process Engineering Manager 

United States, Pennsylvania, Williamsport 

494166349

The Process Engineering Manager will lead the engineering team responsible for developing, optimizing, and maintaining robust injection molding processes for medical device manufacturing. This role requires deep technical expertise in injection molding and process validation within a regulated, high-precision environment. The ideal candidate will ensure compliance with ISO 13485, and GMP requirements, while driving continuous improvement in quality, efficiency, and cost.

• Lead and manage a team of process engineers, process engineering technicians, and validation technicians.
• Develop, validate, and optimize molding processes using scientific molding techniques to ensure high-quality, repeatable manufacturing outcomes.
• Oversee process validation activities (IQ/OQ/PQ) in compliance with ISO 13485 requirements.
• Drive continuous improvement initiatives using Six Sigma, Lean Manufacturing, and other methodologies.
• Interface with Quality and other teams to support new product introductions (NPI) and design for manufacturability (DFM).
• Mentor and develop engineering talent; set performance goals and conduct regular reviews.
• Serve as the primary technical liaison between internal teams and external customers.
• Provide technical support and updates on project timelines, process readiness, and validation status to customers.
• Act as the primary engineering contact for customers during new project development, trials, and production scale-up.
• Review production and operating reports and resolve operational and manufacturing problems to ensure minimum cost and prevent operational delays.
• Develop or revise standard operational and working practices and monitor operations to ensure compliance with standards.
• Support the Sales team with engineering resources to support quoting activities.
• Actively participate and comply with all West HSE and OpEx programs and regulations.
• Maintain a neat and orderly work environment in accordance with West 6S program.
• Other duties as assigned.

• Bachelor’s degree in Mechanical, Plastics, or Manufacturing Engineering.

• Minimum 8 years of experience in injection molding, with at least 3 years in a leadership or management role.
• Proven experience working in the medical device industry with a strong understanding of regulatory requirements (FDA, ISO 13485, GMP) would be an advantage.
• Expertise in scientific molding, process validation, and statistical process control.

• Knowledge of manufacturing processes, workflows, production equipment and industrial techniques.

• Knowledge of Good Manufacturing Practices (GMP) requirements would be an advantage.
• Knowledge of Lean and 6 Sigma Manufacturing

• Excellent communication skills (in English)
• Ability to assert technical solutions and standards in an international environment
• Ability to collaborate well with people across different countries
• Self-motivated, results- and solution-oriented personality
• Ability to work independently
• 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 and quality policies at all times

• 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
• 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
• Observe and interpret situations, analyze and solve problems