This position will execute standard operating procedures (SOPs) supporting reagent manufacturing, validation, and production transfer activities at the CooperSurgical laboratory in Livingston, New Jersey.
Job Summary:
The Laboratory Technician II 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:
• Execute SOPs and perform assigned 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
• Perform basic molecular biology laboratory procedures with accuracy and attention to detail
• Maintain proficiency in applicable procedures and contamination-controlled processing techniques
• 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 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 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 follow procedures and protocols with a high degree of consistency and accuracy • Ability to work effectively within a contamination-controlled processing environment • Ability to interpret procedures, identify minor process issues, and propose improvements when appropriate • Knowledge of good documentation practices and laboratory safety standards
• Ability to communicate and collaborate effectively across cross-functional teams • Strong attention to detail, organization, and documentation accuracy • 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 2–4 years of relevant laboratory and/or manufacturing experience required • Hands-on contamination-controlled processing experience in a laboratory, manufacturing, or controlled environment is required • Experience supporting validation, qualification, 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 manufacturing environments preferred
Education:
• Bachelor’s degree in the sciences required
Travel:
• Limited travel may be required afterward (<10%)
