EV Engineer III in Bedford

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.

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.