Validation Engineer
About The Position
The Equipment Validation Engineer III supports a sterile pharmaceutical manufacturing facility through the qualification and lifecycle management of manufacturing equipment, utilities, and associated systems. The position leads equipment qualification and change-based revalidation activities, supports manufacturing investigations, and collaborates with Operations, Engineering, Maintenance, Quality, and Regulatory functions to ensure compliance with cGMP requirements. The engineer serves as a technical lead for validation projects of moderate to high complexity, applying expertise in risk-based validation strategies, equipment qualification, and continuous process improvement. The role includes exposure to new equipment implementation, capital projects, regulatory inspections, and cross-functional project teams supporting commercial pharmaceutical manufacturing. It also includes mentoring developing engineers and contributing to site validation strategy. The position is based in Bedford, Ohio, and is primarily a first-shift role. Occasional off-shift, weekend, or holiday support may be required for equipment implementation, qualification activities, manufacturing schedules, and project milestones.
Requirements
- Bachelor's degree in Engineering, Life Sciences, Chemistry, Biology, Pharmaceutical Sciences, Mathematics, or a related technical discipline.
- Minimum of 4 years of validation, engineering, pharmaceutical manufacturing, or related industry experience.
- Working knowledge of cGMP regulations and validation principles in regulated manufacturing environments.
- Strong technical writing skills, including experience authoring validation protocols and reports.
- Demonstrated ability to independently manage technical projects and collaborate with cross-functional teams.
- Strong verbal and written communication skills.
Nice To Haves
- 6 or more years of validation experience in pharmaceutical, biotechnology, medical device, or other regulated industries.
- Experience performing equipment qualification activities (IQ/OQ/PQ).
- Experience supporting sterile, aseptic, or parenteral manufacturing operations.
- Familiarity with GAMP 5 for computerized systems.
- Experience with risk assessments, change controls, deviations, investigations, and CAPA systems.
- Experience supporting regulatory inspections and customer audits.
- Experience with commissioning and qualification (C&Q) activities for new equipment and facility projects.
- Demonstrated leadership experience in cross-functional project teams.
- Experience with compounding and formulation equipment, filling equipment, lyophilizers, autoclaves and sterilization systems, clean utilities, CIP/SIP systems, environmental control or HVAC systems, RABS and isolators, or inspection packaging systems.
Responsibilities
- Lead IQ, OQ, and PQ equipment qualification activities for new and existing manufacturing equipment.
- Perform change assessments and lead requalification activities for equipment modifications, process changes, and lifecycle management.
- Author, execute, and review validation impact assessments, protocols, test scripts, summary reports, periodic review reports, and supporting documentation.
- Ensure validation activities comply with applicable cGMP regulations, company procedures, and industry best practices.
- Serve as validation lead for capital projects, equipment implementation efforts, and cross-functional initiatives.
- Partner with Engineering during equipment design, installation, commissioning, startup, and qualification.
- Coordinate qualification activities across Operations, Quality Control, Quality Assurance, Engineering, Maintenance, and Manufacturing Science teams.
- Manage multiple validation projects while maintaining project timelines and priorities.
- Support manufacturing investigations, deviation assessments, root cause analyses, and CAPA implementation related to validated systems.
- Participate in risk assessments and develop scientifically sound validation approaches.
- Identify opportunities to improve validation processes, documentation practices, and operational efficiency.
- Provide technical guidance and support for equipment lifecycle management.
- Maintain validation documentation in an audit-ready state.
- Support internal, client/customer, and regulatory audits and inspections, including FDA and other global regulatory agency inspections.
- Contribute validation documentation and technical justifications for regulatory submissions when required.
- Mentor junior validation engineers and guide them on validation methodologies, documentation practices, and compliance expectations.
- Serve as a technical resource within the Validation organization and across site functions.
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
