PTA Manufacturing Technician II

About CooperSurgical

CooperSurgical is a leading fertility and women’s healthcare company dedicated to putting time on the side of women, babies, and families at the healthcare moments that matter most in life. As a division of CooperCompanies, we're driven by a unified purpose to enable patients to experience life's beautiful moments. Guided by our shared values – dedicated, innovative, friendly, partners, and do the right thing – our offerings support patients throughout their lifetimes, from contraception to fertility and birth solutions, to women’s and family care, and beyond. We currently offer over 600 clinically relevant medical devices to healthcare providers, including testing and treatment options, as well as an innovative suite of assisted reproductive technology and genomic testing solutions. Learn more at www.coopersurgical.com. 

Work location: Livingston, NJ (on-site)

Scope: 

This position will execute standard operating procedures (SOPs) supporting PTA manufacturing, validation, and production transfer activities at the CooperSurgical laboratory in Livingston, New Jersey.

Job Summary:

As a PTA Manufacturing Laboratory Technician II, this individual will perform manufacturing and laboratory tasks of low to intermediate complexity while supporting startup, validation, and routine production activities associated with the PTA value stream. The technician will report directly to the PTA Manufacturing Manager and work cross-functionally with QA, scientists, engineers, and operations teams.
 

The primary responsibility of this role will be to reagent manufacturing in a controlled laboratory environment while supporting process transfer, qualification, and operational readiness activities during the NJ site startup phase.

• Execute a range of SOPs to perform detailed manufacturing tasks independently and in a timely manner
• Perform reagent formulation, filling, labeling, packaging, and related manufacturing activities according to procedure
• Execute routine quality control inspections independently according to procedure
• Perform molecular biology laboratory procedures with a high degree of quality and attention to detail
• Demonstrate and maintain proficiency in applicable procedures and contamination-controlled processing techniques
• Accurately complete production and test records according to good documentation practices (GDP)
• Report process deviations, nonconformances, and operational issues in a timely manner
• Participate in troubleshooting and continuous improvement activities related to manufacturing processes and equipment
• Support equipment qualification, process validation, and manufacturing transfer activities
• Receive, inspect, stock, and organize production inventory and laboratory supplies
• Routinely clean laboratory rooms, controlled areas, and manufacturing equipment
• Perform routine laboratory and equipment maintenance activities
• Participate in procedure reviews and updates, including SOPs, forms, and work instructions
• Support creation and maintenance of manufacturing documentation and technical records
• Collaborate cross-functionally with QA, R&D, engineering, and operations teams to resolve process and product issues
• Comply with all standard operating procedures, quality assurance, safety, and regulatory requirements
• Comply with all corporate regulations, policies, and procedures
• Perform additional duties as assigned by management

Travel: 

• During onboarding and initial startup activities, this role may require extended onsite training at the Houston site for approximately 1–2 months
• Limited travel may be required afterward (<10%)

• 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 documentat