Engineer I - Engineering, Validation
About The Position
The Engineer I - Engineering, Validation supports quality assurance and validation activities at Catalent’s Madison, Wisconsin biologics development and manufacturing facility. The role helps ensure compliance with regulatory and internal quality standards through oversight of validation programs, equipment and utility commissioning and qualification, and collaboration with cross-functional teams. The position contributes to continuous improvement and supports the manufacture and release of high-quality drug substances. The role is onsite in Madison and works Monday through Friday, 8:00 a.m. to 5:00 p.m. Responsibilities include reviewing validation documentation, leading validation activities for new equipment and systems, supporting audits and inspections, and maintaining the Validation Master Plan. The position also provides validation and risk-management expertise, supports investigation and change-control processes, and works with Manufacturing, Process Development, Facilities, Regulatory Affairs, and Quality.
Requirements
- Bachelor's degree in a technical field such as Biology, Biotechnology, Engineering, or a related field, 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 validating and qualifying 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.
- Experience with 21 CFR Part 11 compliance.
- Experience validating computerized systems.
- Experience with continuous improvement and quality systems enhancement.
- 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 a QA subject matter expert for Validation and Risk Management.
- Assess change controls for impact to validated systems.
- Support audits and regulatory inspections.
- Investigate deviations related to validation activities.
- Maintain the Validation Master Plan.
- Collaborate with Manufacturing, Process Development, Facilities, Regulatory Affairs, and Quality teams.
- Manage validation contractors when necessary.
- Provide training and technical support.
Benefits
- Competitive paid time off.
- Eight paid holidays.
- Medical, dental, and vision benefits effective on the first day of employment.
- Tuition reimbursement.
- Defined career path and annual performance review and feedback process.
- Potential for career growth on an expanding team.
- Community engagement and green initiatives.
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What This Job Offers
Job Type
Full-time
Career Level
Entry Level
