This position will execute standard operating procedures (SOPs) supporting reagent manufacturing, validation, and production transfer activities at the CooperSurgical laboratory in Livingston, New Jersey.
The Laboratory Technician III will support reagent manufacturing activities at the CooperSurgical laboratory in Livingston, NJ. This role will perform routine laboratory and manufacturing activities, follow established procedures, maintain accurate documentation, and support validation and production readiness.The technician will work closely with Manufacturing, Quality, Engineering, and other cross-functional teams.
Responsibilities
Essential Functions & Accountabilities:
• Support daily manufacturing activities and production priorities according to the production schedule
• Serve as a technical resource to other laboratory technicians during routine manufacturing activities
• Execute SOPs and perform complex manufacturing tasks independently and in a timely manner
• Perform reagent formulation, filling, labeling, packaging, and related manufacturing activities according to procedure
• Perform routine quality control inspections according to procedure
• Maintain proficiency in contamination-controlled processing techniques and laboratory workflows
• Support contamination prevention and good laboratory practices during manufacturing operations
• Assist with onboarding and hands-on training of new technicians as needed
• Accurately complete production and test records according to good documentation practices (GDP)
• Report deviations, nonconformances, and operational issues in a timely manner
• Participate in troubleshooting, root cause investigations, and continuous improvement activities
• Support equipment qualification, process validation, and manufacturing transfer activities
• Receive, inspect, stock, and organize production materials and laboratory supplies
• Perform routine laboratory cleaning and equipment maintenance
• Participate in reviews and updates of SOPs, forms, and work instructions
• Support manufacturing documentation and technical records
• Collaborate with QA, R&D, Engineering, and Operations to support manufacturing and resolve process or product issues
• Follow all applicable SOPs, quality, safety, regulatory, and corporate requirements
• Perform additional duties as assigned by management
Qualifications
Qualifications, Knowledge, Skills and Abilities:
• Understanding of fundamental biochemical and molecular biology concepts (e.g., nucleic acid structure, PCR, pH, contamination control, etc.)
• Ability to work effectively within a contamination-controlled processing environment • Strong understanding of contamination prevention practices, gowning procedures, and controlled workflow behaviors • Ability to follow procedures and protocols with a high degree of consistency and accuracy • Ability to identify operational issues and support troubleshooting activities in a manufacturing environment • Ability to communicate and collaborate effectively across cross-functional teams • Strong attention to detail, organization, and documentation accuracy • Ability to support training and coordination of junior laboratory personnel • Ability to perform repetitive pipetting and laboratory tasks for extended periods of time • Proficiency with Microsoft Office programs including Excel, Word, and PowerPoint • Ability to maintain confidentiality as required
Work Environment:
• Frequent reaching, grasping, repetitive motions, and eye/hand coordination • Ability to work in office and laboratory/manufacturing environments • Ability to wear contamination-controlled processing garments, gloves, eye protection, and masks for extended periods • Ability to sit or stand for extended periods of time • Ability to lift up to 50 lbs
Experience:
• Minimum 3–5 years of relevant laboratory and/or manufacturing experience required • Hands-on experience in a laboratory, manufacturing, or contamination-controlled environment is required • Prior experience supporting production execution, floor coordination, or technician training activities preferred • Experience supporting validation, qualification, startup, or manufacturing transfer activities preferred • Experience with molecular biology laboratory techniques preferred, including PCR, qPCR, DNA extraction, next-generation sequencing workflows, or related methods • Experience working with electronic quality systems, manufacturing systems, or laboratory information systems is preferred
• Experience working in GMP or regulated manufacturing environments preferred
Education:
• Bachelor’s degree in the sciences required
Travel:
• Limited travel may be required afterward (<10%)
