Engineer I - Engineering, Validation
About The Position
The Engineer I - Engineering, Validation supports quality assurance and validation activities to ensure compliance with regulatory and internal quality standards. The role oversees validation programs, supports commissioning and qualification of equipment, and collaborates with cross-functional teams to maintain quality and compliance. The successful candidate contributes to continuous improvement and supports the manufacture and release of high-quality drug substances. The position is based onsite at Catalent’s biologics development and manufacturing facility in Madison, Wisconsin, and follows a Monday–Friday, 8 a.m.–5 p.m. schedule.
Requirements
- Bachelor's degree in a technical field (Biology, Biotechnology, Engineering, or related) with 7 or more years of relevant experience, or a master's degree in a technical field with 4 or more years of relevant experience.
- Strong knowledge of cGMP regulations.
- Knowledge of validation standards, including ISPE and ASTM.
- Experience with validation and qualification of complex equipment and systems.
- Experience drafting, reviewing, executing, and approving validation protocols and reports.
- Experience supporting validation activities in a regulated pharmaceutical or biotech environment.
- Experience with change controls, deviations, CAPAs, investigations, and risk assessments.
Nice To Haves
- Biopharmaceutical, biotech, or pharmaceutical manufacturing experience.
- Experience with aseptic processing.
- Experience with cell culture.
- Experience with protein purification.
- Process validation experience.
- 21 CFR Part 11 compliance experience.
- Validation of computerized systems.
- Continuous improvement and quality systems enhancement experience.
- Quality Risk Management expertise.
Responsibilities
- Review and approve validation documents.
- Support commissioning and qualification of equipment and utilities.
- Lead validation activities for new equipment and systems.
- Serve as the QA subject matter expert for Validation and Risk Management.
- Assess change controls for their impact on validated systems.
- Support audits and regulatory inspections.
- Investigate deviations related to validation activities.
- Maintain the Validation Master Plan.
- Partner with Manufacturing, Process Development, Facilities, Regulatory Affairs, and Quality teams.
- Manage validation contractors when necessary.
- Provide training and technical support.
Benefits
- Defined career path and annual performance review and feedback process.
- Diverse, inclusive culture.
- Potential for career growth on an expanding team.
- Competitive paid time off.
- Eight paid holidays.
- Community engagement and green initiatives.
- Medical, dental, and vision benefits effective on the first day of employment.
- Tuition reimbursement.
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What This Job Offers
Job Type
Full-time
Career Level
Entry Level
