Job Title: Equipment Validation Engineer
Location: Bedford, Ohio
Job Type: Full-Time
Summary
The Equipment Validation Engineer III plays a key role in supporting a sterile pharmaceutical manufacturing facility through the qualification and lifecycle management of manufacturing equipment, utilities, and associated systems. This 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 successful candidate will serve as a technical lead for validation projects of moderate to high complexity, providing expertise in risk-based validation strategies, equipment qualification, and continuous process improvement. This role offers significant exposure to new equipment implementation, regulatory inspections, and cross-functional project teams supporting commercial pharmaceutical manufacturing.
Why Join Our Team?
- Opportunity to lead high-impact validation projects in a sterile pharmaceutical manufacturing environment.
- Exposure to equipment implementation, capital projects, and advanced manufacturing technologies.
- Collaborative cross-functional environment with Operations, Engineering, Quality, and Regulatory organizations.
- Opportunity to mentor developing engineers and influence site validation strategy.
- Direct contribution to the manufacture of critical pharmaceutical products that impact patient health.
Essential Duties and Responsibilities
Equipment Qualification & Validation
- Lead equipment qualification activities, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) for new and existing manufacturing equipment.
- Perform change assessments and lead requalification activities in support of 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 are executed in accordance with applicable cGMP regulations, company procedures, and industry best practices.
Project Leadership
- 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 phases.
- Coordinate qualification activities across Operations, Quality Control, Quality Assurance, Engineering, Maintenance, and Manufacturing Science teams.
- Manage multiple validation projects simultaneously while maintaining project timelines and priorities.
Technical Support & Continuous Improvement
- Support manufacturing investigations, deviation assessments, root cause analyses, and CAPA implementation activities 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 activities.
Compliance & Regulatory Support
- Maintain validation documentation in a state of audit readiness.
- Support internal audits, client/customer audits, and regulatory inspections, including FDA and other global regulatory agencies.
- Contribute validation documentation and technical justifications for regulatory submissions when required.
Leadership & Mentoring
- Mentor junior validation engineers and provide guidance on validation methodologies, documentation practices, and compliance expectations.
- Serve as a technical resource within the Validation organization and across site functions.
Required Qualifications
- Bachelor's degree in Engineering, Life Sciences, Chemistry, Biology, Pharmaceutical Sciences, Mathematics, or related technical discipline.
- Minimum of 4 years of validation, engineering, pharmaceutical manufacturing, or related industry experience.
- Working knowledge of cGMP regulations and validation principles within regulated manufacturing environments.
- Strong technical writing skills with 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.
Preferred Qualifications
- 6+ years of validation experience within 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.
Preferred Technical Experienc e
Experience with one or more of the following is highly desirable:
- Compounding and formulation equipment
- Filling equipment
- Lyophilizers
- Autoclaves and sterilization systems
- Clean utilities
- CIP/SIP systems
- Environmental control or HVAC systems
- RABS and Isolators
- Inspection packaging systems
Physical Requirements
- Ability to routinely work in manufacturing and laboratory environments.
- Ability to walk throughout the facility and stand for extended periods during qualification and project activities.
- Ability to lift up to 40 lbs occasionally.
- Ability to utilize appropriate personal protective equipment (PPE) as required.
Work Schedule
This position is primarily a first-shift role. Occasional off-shift, weekend, or holiday support may be required to support equipment implementation, qualification activities, manufacturing schedules, and project milestones.