DescriptionAs a Qualification Engineer, you will perform Commissioning, Qualification, and Validation (CQV) activities for pharmaceutical manufacturing equipment, facilities, and utilities. You will develop and execute commissioning and validation protocols while ensuring equipment and manufacturing systems comply with FDA regulations and Good Manufacturing Practices (GMP).This role is ideal for candidates with pharmaceutical validation, commissioning, quality engineering, manufacturing, automation, or military technical experience.
Responsibilities- Develop and execute commissioning protocols.
- Perform Factory Acceptance Testing (FAT) and Site Acceptance Testing (SAT).
- Execute Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).
- Perform process, cleaning, and computer systems validation.
- Prepare validation plans, protocols, reports, and traceability documentation.
- Ensure compliance with FDA, GMP, and regulatory requirements.
- Participate in risk assessments and mitigation planning.
- Collaborate with Quality, Manufacturing, Engineering, and Regulatory teams.
- Support startup, equipment walkdowns, and troubleshooting.
- Identify and implement continuous improvement opportunities.
Must-Have Skills, Experience, and Education- Bachelor's degree in engineering, Life Sciences, or related field.
- 3-5 years of CQV experience in an FDA-regulated manufacturing environment.
- Experience with FAT, SAT, IQ, OQ, PQ, URS, P&IDs, equipment startup, and validation.
- Strong understanding of GMP and FDA regulations.
- Excellent technical writing and documentation skills.
- Ability to travel 50-70%.
Nice-to-Have Skills- Biotech manufacturing
- Aseptic processing
- Fill/Finish
- Gene Therapy
- GMP
- FDA compliance
- CQV
- Validation software
- ASQ Certified Quality Engineer
- Pharmaceutical manufacturing
