West Pharmaceutical Services · 7 hours ago
Sr Associate, Quality Engineering
Walker, MI
Full-time
Onsite
Senior Level
6+ years expWest Pharmaceutical Services is a company dedicated to improving patient lives through innovative healthcare solutions. The Sr Associate, Quality Engineering will provide support for the validation program, ensuring compliance with regulatory and ISO Management standards while guiding stakeholders in validation life cycle documentation.
BiotechnologyHealth CareIndustrialManufacturingPackaging ServicesPharmaceutical
No H1B
Responsibilities
Responsible for compliance to West’s validation program
Ensure that the validation requirements are documented to provide direction for meeting the validation needs of the customers, associated regulatory bodies and West functional groups
Provide guidance to system/process stakeholders as to content and format of Validation life cycle documentation. candidate shall demonstrate hands-on experience planning, establishing and executing software validation activities
Support Engineering and Operations groups during the process development and Validation phases of customer products’ life cycles
Provide required training to support qualification activities
Assume the QA responsibilities for reviewing and approval of validation life cycle documentation (PDD, IOQ/PQ protocols, protocol addendums, summary reports, etc.)
Provide guidance during protocol incidents process, including reporting, investigations and approval of resolutions
Keep current with all Industry standard practices and FDA requirements for validation, change control and complaint handling
Monitor Change Control system and provide guidance for proper execution and timely closure of Change Controls and Action items
Understanding and facilitation of Risk documentation to ensure compliance with ISO 14971 and ISO 31000
Ensure compliance with Quality, Business Continuity, Safety and Environmental standards and applicable regulations
Experience with risk management and task prioritization a must for this role
Other duties as assigned
Qualification
Required
Bachelor's degree or equivalent experience in a technical discipline including Biology/Microbiology, Chemistry or Engineering
6 - 10 Years of experience in Quality Systems
Responsible for compliance to West's validation program
Ensure that the validation requirements are documented to provide direction for meeting the validation needs of the customers, associated regulatory bodies and West functional groups
Provide guidance to system/process stakeholders as to content and format of Validation life cycle documentation
Candidate shall demonstrate hands-on experience planning, establishing and executing software validation activities
Support Engineering and Operations groups during the process development and Validation phases of customer products' life cycles
Provide required training to support qualification activities
Assume the QA responsibilities for reviewing and approval of validation life cycle documentation (PDD, IOQ/PQ protocols, protocol addendums, summary reports, etc.)
Provide guidance during protocol incidents process, including reporting, investigations and approval of resolutions
Keep current with all Industry standard practices and FDA requirements for validation, change control and complaint handling
Monitor Change Control system and provide guidance for proper execution and timely closure of Change Controls and Action items
Understanding and facilitation of Risk documentation to ensure compliance with ISO 14971 and ISO 31000
Ensure compliance with Quality, Business Continuity, Safety and Environmental standards and applicable regulations
Experience with risk management and task prioritization a must for this role
Able to comprehend mechanical drawings, computer systems and manufacturing processes
Preferred
Graduate degree (MS) preferred
Minimum of two (2) years' experience writing, executing and summarizing protocols
Knowledge of FDA, cGMP, ISO and Clean Room standards
Knowledge of validation of automated assembly, software, and manufacturing processes
Knowledge of ANSI/ISO standards
Excellent written and verbal communication skills
Good problem-solving skills and be able to function independently or as a member of a team
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
Company
West Pharmaceutical Services
West Pharmaceutical Services is a manufacturer of technologically advanced containment and delivery systems for injectable medicines.
5001-10000 employees
Funding
Current Stage
Public CompanyTotal Funding
unknown1978-01-13IPO
Leadership Team
Eric Green
President, CEO and Chair of the Board
A
Annette Favorite
Sr. Vice President and Chief Human Resources Officer
Recent News
2025-12-06
Company data provided by crunchbase