Equipment Validation Engineer

Hikma Pharmaceuticals; Bedford (OH); Vor Ort; USD 90.000 - 120.000; Vollzeit

Zusammenfassung

Hikma Pharmaceuticals in Bedford, OH seeks an Equipment Validation Engineer III to lead qualification activities for sterile manufacturing equipment and support lifecycle management. You will guide IQ/OQ/PQ efforts, collaborate with Operations, Engineering, Quality, and Regulatory teams, and ensure compliant validation practices across projects.

The role emphasizes risk-based validation strategies, documentation rigor, and continuous process improvement, with opportunities to mentor junior

Qualifikationen

• 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.

Aufgaben

• Lead equipment qualification activities, including IQ, OQ, and 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.
• 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.
• 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.
• Maintain validation documentation in a state of audit readiness.
• Support internal audits, client/customer audits, and regulatory inspections, including FDA and global regulatory agencies.
• Contribute validation documentation and technical justifications for regulatory submissions when required.
• Mentor junior validation engineers and provide guidance on validation methodologies, documentation practices, and compliance expectations.

Kenntnisse

Technical writing

Project management

Cross-functional collaboration

Communication skills

Ausbildung

Bachelor's degree in Engineering or related field

Tools

GAMP 5

Jobbeschreibung

Job Title: Equipment Validation Engineer

Location: Bedford, Ohio

Job Type: Full-Time

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.
• 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.
• 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 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 Experienc e

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

• Compounding and formulation equipment
• Filling equipment
• Autoclaves and sterilization systems
• 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.