Title:  EV Engineer III

Job Title: Equipment Validation Engineer III 

Location: Bedford, Ohio 

Job Type: Full-Time 

Req ID: 11964 

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 Experience 

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.