VHP Validation Engineer / Specialist
Position Summary
The VHP Validation Engineer/Specialist is responsible for planning, executing, and documenting qualification and validation activities for Vaporized Hydrogen Peroxide (VHP) systems and associated equipment used in regulated pharmaceutical, biotechnology, or aseptic manufacturing environments. The role ensures VHP systems consistently perform as intended and meet applicable GMP, regulatory, and site requirements.
The position will work closely with Engineering, Manufacturing, Quality Assurance, Microbiology, and external equipment vendors to develop and execute validation strategies, protocols, and reports.
Key Responsibilities
- Develop and execute validation and qualification activities for VHP generators, bio-decontamination systems, chambers, pass-throughs, isolators, rooms, and associated equipment.
- Develop and execute URS, risk assessments, DQ, IQ, OQ, PQ, and other applicable qualification documentation.
- Develop VHP cycle development and validation strategies, including evaluation of:
- Ensure critical instruments associated with VHP systems are appropriately calibrated and qualified.
- Support change control, deviation, CAPA, and periodic review activities associated with validated VHP systems.
- Provide technical guidance regarding VHP cycle optimization, equipment performance, and validation requirements.
Required Qualifications
- Bachelor's degree in Engineering, Microbiology, Pharmaceutical Sciences, Chemistry, or a related scientific/technical discipline.
- 3+ years of experience in pharmaceutical, biotechnology, medical device, or other regulated manufacturing environments, with experience in equipment or process validation.
- Demonstrated experience with VHP/HO biodecontamination systems and validation activities.
- Strong understanding of GMP principles and equipment qualification/validation methodologies.
- Experience developing and executing IQ/OQ/PQ protocols and reports.
- Experience with risk assessments, deviations, CAPA, and change controls.
- Experience working with controlled documentation in a regulated environment.
- Ability to interpret engineering drawings, equipment specifications, and technical documentation.
- Strong technical writing, analytical, and problem-solving skills.
Core Competencies
- VHP/biodecontamination validation
- Equipment qualification
- IQ/OQ/PQ
- Cycle development and optimization
- GMP documentation
- Risk assessment
- Deviation/CAPA investigation
- Technical troubleshooting
Work Authorization:
Candidates must be legally authorized to work in the United States. This position is not eligible for employment visa sponsorship.