Pharmaceutical API Technician
Eurofins PSS Insourcing Solutions
Job Description You will be part of a multi‑disciplinary team responsible for the Current Good Manufacturing Practices (cGMP) production of non‑commercial size clinical batches supporting Active Pharmaceutical Ingredient (API) development. This includes supporting the manufacturing operations team, reviewing Standard Operating Procedures, executing batch records, and supporting commissioning and qualification of process equipment. Standard work involves chemical synthesis of API, including solid/liquid charges to vessels, atmospheric/vacuum distillations, liquid‑liquid extractions, phase cut, crystallization, filtrations and drying. Role Responsibilities Execute Process Operating Instructions in a cGMP environment. Equipment preparation, operational adjustment, process monitoring, sampling, and cleaning of complex pharmaceutical manufacturing equipment as defined in SOPs. Perform manual handling tasks, including lifting, carrying, and moving objects up to and exceeding 50 pounds on a routine basis. Handle and segregate manufacturing waste per approved waste management, environmental, and safety requirements. Support equipment qualification/commissioning activities. Adhere to cGMP and local operating procedure requirements. Complete recurring assignments independently and select the most appropriate method within prescribed limits of authority. Identify opportunities for continuous improvements and enable implementation. Maintain cross‑functional communication with the tech transfer team: Compliance, Quality, Process Chemists, Analysts, and Process Supervisors. Perform troubleshooting of manufacturing support equipment and operations. Generate, assist, and execute documentation associated with cGMP API manufacture, such as batch record, cleaning documentation, and in‑process control sampling. Support Standard Operating Procedure periodic reviews. Report any deviations or observations that might impact product quality or process safety. Actively participate in shift exchange activities and communication channels. Complete training to take part in safety inspections within the facility. Manage own time, professional development, and be accountable for own results. Prioritize workflow and assist in prioritizing workflow of less‑experienced colleagues. Qualifications Basic Minimum Qualifications High School Diploma or GED 4+ years of relative experience Demonstrated experience in a cGMP manufacturing environment. Operational knowledge of Production Control Systems Ability to think critically and demonstrate troubleshooting and problem‑solving skills Strong workload planning skills, organization, attention to detail, and follow‑through Demonstrated capability to work as an independent contributor within a matrix development team Physically capable of standing for prolonged periods, lifting up to or exceeding 50 lbs, wearing protective equipment and handling hazardous materials. Excellent written and verbal communication skills Strong computer skills in Microsoft Office (e.g., Word, Excel) Preferred Qualifications Associate degree (Science or technical discipline) Strong mechanical aptitude and desire to execute hands‑on manual labor Experience with Delta V Production Control System Experience in a Pharmaceutical cGMP manufacturing environment Experience performing large‑scale distillations, filtrations, milling Additional Information After approximately 3 months of initial training (Monday‑Friday 8 am‑5 pm) the team member moves to swing shift alternating between 1st and 2nd shift: 1st Shift is Mon‑Fri 6 am‑2 pm; 2nd Shift is Mon‑Thu 2 pm‑12 am. May be requested to work weekends, overtime, and holidays based on business needs. Candidates living within commutable distance of Groton, CT are encouraged to apply. Ability to work overtime as required. Excellent full‑time benefits, including comprehensive medical coverage, dental, and vision options. Life and disability insurance. 401(k) with company match. Paid vacation and holidays. Authorization to work in the United States indefinitely without restriction or sponsorship. EEO Statement Eurofins USA PSS Insourcing Solutions is a Disabled and Veteran Equal Employment Opportunity employer. #J-18808-Ljbffr Eurofins PSS Insourcing Solutions
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