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.

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