Job Description
Job Description
Job Title: Equipment Validation Engineer III
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Location: Bedford, Ohio
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Job Type: Full-Time
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Req ID: 11964
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Summary
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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.
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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.
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Why Join Our Team?
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\n - Opportunity to lead high-impact validation projects in a sterile pharmaceutical manufacturing environment.
\n - Exposure to equipment implementation, capital projects, and advanced manufacturing technologies.
\n - Collaborative cross-functional environment with Operations, Engineering, Quality, and Regulatory organizations.
\n - Opportunity to mentor developing engineers and influence site validation strategy.
\n - Direct contribution to the manufacture of critical pharmaceutical products that impact patient health.
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Essential Duties and Responsibilities
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Equipment Qualification & Validation
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\n - 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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\n - Author, execute, and review validation impact assessments, protocols, test scripts, summary reports, periodic review reports and supporting documentation.
\n - 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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\n - Serve as validation lead for capital projects, equipment implementation efforts, and cross-functional initiatives.
\n - Partner with Engineering during equipment design, installation, commissioning, startup, and qualification phases.
\n - Coordinate qualification activities across Operations, Quality Control, Quality Assurance, Engineering, Maintenance, and Manufacturing Science teams.
\n - Manage multiple validation projects simultaneously while maintaining project timelines and priorities.
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Technical Support & Continuous Improvement
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\n - Support manufacturing investigations, deviation assessments, root cause analyses, and CAPA implementation activities related to validated systems.
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\n - Provide technical guidance and support for equipment lifecycle management activities.
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Compliance & Regulatory Support
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\n - Maintain validation documentation in a state of audit readiness.
\n - Support internal audits, client/customer audits, and regulatory inspections, including FDA and other global regulatory agencies.
\n - Contribute validation documentation and technical justifications for regulatory submissions when required.
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Leadership & Mentoring
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\n - Mentor junior validation engineers and provide guidance on validation methodologies, documentation practices, and compliance expectations.
\n - Serve as a technical resource within the Validation organization and across site functions.
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Required Qualifications
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\n - Bachelor's degree in Engineering, Life Sciences, Chemistry, Biology, Pharmaceutical Sciences, Mathematics, or related technical discipline.
\n - Minimum of 4 years of validation, engineering, pharmaceutical manufacturing, or related industry experience.
\n - Working knowledge of cGMP regulations and validation principles within regulated manufacturing environments.
\n - Strong technical writing skills with experience authoring validation protocols and reports.
\n - Demonstrated ability to independently manage technical projects and collaborate with cross-functional teams.
\n - Strong verbal and written communication skills.
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Preferred Qualifications
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\n - 6+ years of validation experience within pharmaceutical, biotechnology, medical device, or other regulated industries.
\n - Experience performing equipment qualification activities (IQ/OQ/PQ).
\n - Experience supporting sterile, aseptic, or parenteral manufacturing operations.
\n - Familiarity with GAMP 5 (for computerized systems).
\n - Experience with risk assessments, change controls, deviations, investigations, and CAPA systems.
\n - Experience supporting regulatory inspections and customer audits.
\n - Experience with commissioning and qualification (C&Q) activities for new equipment and facility projects.
\n - Demonstrated leadership experience in cross-functional project teams.
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Preferred Technical Experience
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Experience with one or more of the following is highly desirable:
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\n - Compounding and formulation equipment
\n - Filling equipment
\n - Lyophilizers
\n - Autoclaves and sterilization systems
\n - Clean utilities
\n - CIP/SIP systems
\n - Environmental control or HVAC systems
\n - RABS and Isolators
\n - Inspection packaging systems
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Physical Requirements
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\n - Ability to routinely work in manufacturing and laboratory environments.
\n - Ability to walk throughout the facility and stand for extended periods during qualification and project activities.
\n - Ability to lift up to 40 lbs occasionally.
\n - Ability to utilize appropriate personal protective equipment (PPE) as required.
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Work Schedule
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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.
Job Tags
Full time, Shift work, Day shift