Ecocareers ยท 1 month ago
Quality Equipment Qualification Engineer
Millburn, NJ
Full-time
Onsite
Mid Level
3+ years expConfidential company is seeking a detail-oriented and experienced Equipment Qualification Contractor to support the qualification of laboratory equipment in compliance with cGMP and regulatory standards. The contractor will be responsible for executing qualification protocols, preparing documentation, and ensuring equipment is fit for intended use in a pharmaceutical quality control environment.
Staffing & Recruiting
Responsibilities
Develop, review, and execute Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) protocols
Collaborate with cross-functional teams (QC, QA, Engineering, Validation) to ensure timely and appropriate qualification
Prepare and maintain User Requirement Specifications (URS) and Design Qualification (DQ) documentation
Ensure all qualification activities are documented accurately and meet FDA, EMA, and ICH guidelines
Qualification
Required
Bachelor's degree in Engineering, Life Sciences, or related field
Minimum 3 years of experience in equipment qualification within a GMP-regulated pharmaceutical or biotech environment
Good understanding of Good Manufacturing Practices (GMP) and Good Engineering Practices (GEP)
Experience with laboratory instruments (e.g., HPLC, GC, incubators, autoclaves) and manufacturing equipment
Proficient in writing and reviewing technical documentation
Excellent organizational and communication skills
Experience with computer system validation (CSV) and data integrity principles
Ability to work independently and manage multiple priorities
Company
Ecocareers
Ecocareers provides a specialized job search for careers that make a difference.
2-10 employees
Funding
Current Stage
Early StageCompany data provided by crunchbase