Validation Engineer

Job Description

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?

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• Opportunity to lead high-impact validation projects in a sterile pharmaceutical manufacturing environment.
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• Exposure to equipment implementation, capital projects, and advanced manufacturing technologies.
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• Collaborative cross-functional environment with Operations, Engineering, Quality, and Regulatory organizations.
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• Opportunity to mentor developing engineers and influence site validation strategy.
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• Direct contribution to the manufacture of critical pharmaceutical products that impact patient health.
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Essential Duties and Responsibilities

Equipment Qualification & Validation

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• Lead equipment qualification activities, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) for new and existing manufacturing equipment.
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• Perform change assessments and lead requalification activities in support of equipment modifications, process changes, and lifecycle management.
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• Author, execute, and review validation impact assessments, protocols, test scripts, summary reports, periodic review reports and supporting documentation.
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• Ensure validation activities are executed in accordance with applicable cGMP regulations, company procedures, and industry best practices.
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Project Leadership

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• Serve as validation lead for capital projects, equipment implementation efforts, and cross-functional initiatives.
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• Partner with Engineering during equipment design, installation, commissioning, startup, and qualification phases.
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• Coordinate qualification activities across Operations, Quality Control, Quality Assurance, Engineering, Maintenance, and Manufacturing Science teams.
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• Manage multiple validation projects simultaneously while maintaining project timelines and priorities.
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Technical Support & Continuous Improvement

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• Support manufacturing investigations, deviation assessments, root cause analyses, and CAPA implementation activities related to validated systems.
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• Participate in risk assessments and develop scientifically sound validation approaches.
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• Identify opportunities to improve validation processes, documentation practices, and operational efficiency.
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• Provide technical guidance and support for equipment lifecycle management activities.
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Compliance & Regulatory Support

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• Maintain validation documentation in a state of audit readiness.
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• Support internal audits, client/customer audits, and regulatory inspections, including FDA and other global regulatory agencies.
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• Contribute validation documentation and technical justifications for regulatory submissions when required.
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Leadership & Mentoring

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• Mentor junior validation engineers and provide guidance on validation methodologies, documentation practices, and compliance expectations.
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• Serve as a technical resource within the Validation organization and across site functions.
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Required Qualifications

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• Bachelor's degree in Engineering, Life Sciences, Chemistry, Biology, Pharmaceutical Sciences, Mathematics, or related technical discipline.
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• Minimum of 4 years of validation, engineering, pharmaceutical manufacturing, or related industry experience.
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• Working knowledge of cGMP regulations and validation principles within regulated manufacturing environments.
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• Strong technical writing skills with experience authoring validation protocols and reports.
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• Demonstrated ability to independently manage technical projects and collaborate with cross-functional teams.
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• Strong verbal and written communication skills.
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Preferred Qualifications

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• 6+ years of validation experience within pharmaceutical, biotechnology, medical device, or other regulated industries.
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• Experience performing equipment qualification activities (IQ/OQ/PQ).
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• Experience supporting sterile, aseptic, or parenteral manufacturing operations.
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• Familiarity with GAMP 5 (for computerized systems).
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• Experience with risk assessments, change controls, deviations, investigations, and CAPA systems.
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• Experience supporting regulatory inspections and customer audits.
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• Experience with commissioning and qualification (C&Q) activities for new equipment and facility projects.
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• Demonstrated leadership experience in cross-functional project teams.
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Preferred Technical Experience

Experience with one or more of the following is highly desirable:

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• Compounding and formulation equipment
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• Filling equipment
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• Lyophilizers
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• Autoclaves and sterilization systems
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• Clean utilities
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• CIP/SIP systems
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• Environmental control or HVAC systems
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• RABS and Isolators
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• Inspection packaging systems
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Physical Requirements

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• Ability to routinely work in manufacturing and laboratory environments.
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• Ability to walk throughout the facility and stand for extended periods during qualification and project activities.
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• Ability to lift up to 40 lbs occasionally.
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• Ability to utilize appropriate personal protective equipment (PPE) as required.
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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.