Role Overview:We are seeking an experienced Equipment Qualification Engineer to support equipment qualification activities at a Summit, New Jersey site. The ideal candidate will have hands-on experience executing qualification lifecycle activities for GMP-regulated manufacturing or laboratory equipment and possess a strong understanding of validation and qualification requirements within the pharmaceutical, biotechnology, or life sciences industry.
Key Responsibilities:- Execute equipment qualification activities, including IQ, OQ, PQ, and requalification.
- Prepare, review, and execute qualification protocols and reports.
- Support commissioning, qualification, and validation activities for manufacturing and laboratory equipment.
- Collaborate with Engineering, Manufacturing, Quality Assurance, and Validation teams to ensure timely project execution.
- Review and assess vendor documentation, including FAT/SAT documentation and qualification packages.
- Support deviation investigations, change controls, and CAPA activities associated with equipment qualification.
- Ensure compliance with GMP, GDP, and applicable regulatory requirements.
- Maintain qualification documentation and provide support during inspections and audits.
Required Skills:- Strong experience with qualification lifecycle documentation (URS, DQ, IQ, OQ, PQ, FAT, SAT).
- Familiarity with GMP regulations and validation principles.
- Experience working in manufacturing, laboratory, or cell therapy environments.
- Excellent documentation, communication, and stakeholder management skills.
Qualifications:- Bachelors degree in Engineering, Life Sciences, Pharmacy, or a related discipline.
- Minimum 5+ years of experience in Equipment Qualification within the pharmaceutical, biotechnology, or medical device industry.
Preferred Skills:- Prior experience qualifying bioprocessing and cell therapy manufacturing equipment.
- Experience with Cytiva Sepax equipment is highly desirable.
- Experience supporting commissioning and startup activities for new equipment installations.
- Knowledge of data integrity and computerized system interfaces associated with equipment.
- Hands-on experience with Cytiva Sepax Cell Processing Systems will be considered a significant advantage.
