About WestWest is a dedicated team united by a purpose to improve patient lives. Our legacy began in World War 2 with the mass supply of penicillin to the U.S. Government and continues today through the delivery of thousands of life‑saving injectable medicines to millions of patients daily. We offer an inclusive community with opportunities for lifelong learning, growth, and development, supported by benefit programs that empower the physical, mental, emotional, and financial health of our team members and their families. West is committed to giving back to communities, creating a healthier environment, and advancing sustainability efforts.
Job Summary
In this role, you will report to the Engineering Manager and serve as the Senior Validation Engineer for West Waterford. You will maintain the validation program by writing, reviewing, and approving validation documentation.
Essential Duties And Responsibilities
Assure compliance with West Pharmaceutical Systems.
Document validation requirements to guide compliance with customers, regulatory bodies, manufacturing plants, R&D, IT, and laboratory groups.
Provide guidance to system/process stakeholders on the content and format of validation life‑cycle documentation.
Write protocols and reports, assessment criteria (Validation Rationale), compliance guidelines, specifications, etc.
Review and approve validation life‑cycle documentation, including change‑control documents, specifications, protocols, deviations, and reports.
Guide protocol incident processes, including reporting, investigations, and approval of resolutions.
Stay current with industry standard practices and FDA requirements for validation.
Write/revise validation templates and plans.
Manage 3rd‑party service contracts for facility‑utility related systems.
Schedule or perform periodic reviews or re‑qualification to maintain validated status of equipment, facilities, and utilities as defined by West master plans and SOIs.
Collaborate with vendor representatives on direct and indirect facility/utility systems for start‑up, testing, witnessing, and troubleshooting.
Support CAPA, change control, deviations, risk analysis, root‑cause analysis, and other quality‑system deliverables for the engineering group.
Comply with engineering standards, drawing controls, and West SOIs for successful operation of facility/utility systems.
Generate and periodically review engineering‑related SOIs for the engineering group.
Participate in ongoing and new projects associated with direct and indirect systems through planning, execution, and witnessing of commissioning and validation protocols.
Compile data on facility‑related systems for presentation at management and quality review forums.
Support standardization and harmonization of existing and new facilities and implement standards through collaboration with the Global Facilities group.
Apply global technical engineering guidelines to support and standardize facility engineering.
Basic Qualifications
Minimum Bachelor of Science Degree in Engineering or Science.
Preferred Knowledge, Skills And Abilities
Minimum 5 years of experience writing, approving, and executing validation protocols and reports in Process Validation, Steam Sterilization, Equipment/Utility Qualification, and Computer System Validation.
Ability to comprehend computer system applications and business/m manufacturing processes.
Strong competence in IT.
Good verbal and written communication skills.
Excellent interpersonal skills with the ability to work with all levels within the organization.
Team player.
Structured work approach and strong organizational skills.
Ability to interact with suppliers, customers, and external contractors.
Knowledge of current ICH, ASTM, FDA, ISPE, and ISO standards and guidelines and application for new projects.
Travel Requirements
20%: Up to 52 business days per year.
Equal Employment Opportunity
West embraces diversity and equality of opportunity. We foster an environment where all individuals are safe, treated fairly, valued, and respected. We do not discriminate on the basis of race, religion, color, national origin, gender, sex, gender identity, sexual orientation, age, marital status, veteran status, disability status, or other legally protected characteristics. Where permitted by law, employment with West Pharmaceutical Services, Inc. or any of its subsidiary or affiliate companies is contingent upon the satisfactory completion of post‑offer background screening.
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