Manufacturing Associate – cGMP API Production

Eurofins USA PSS Insourcing Solutions•Groton, CT

21h•Onsite

About The Position

Eurofins Scientific is an international life sciences company, providing a unique range of analytical testing services to clients across multiple industries, to make life and our environment safer, healthier and more sustainable. The Eurofins network of companies is the global leader in food, environment, pharmaceutical and cosmetic product testing and in agroscience Contract Research Organisation services. In over 30 years, Eurofins has grown to 58,000 staff across 900 laboratories in over 54 countries. The Manufacturing Associate will be a key member of a multidisciplinary manufacturing team supporting the cGMP production of non‑commercial clinical API batches. This role is hands‑on and process‑driven, contributing directly to API development by executing batch operations, supporting equipment qualification, and ensuring compliance with cGMP and safety standards. Work is performed in a pilot‑scale manufacturing environment with close collaboration across Quality, Compliance, and technical teams. Standard operations involve chemical synthesis of APIs, including solid and liquid handling, distillation, extraction, crystallization, filtration, and drying.

Requirements

High School Diploma or GED required
4+ years of relevant manufacturing experience
Demonstrated experience in a cGMP pharmaceutical manufacturing environment
Working knowledge of Production Control Systems
Strong troubleshooting, problem‑solving, and critical‑thinking skills
Ability to work independently while contributing effectively within a matrix team
Strong organizational skills, attention to detail, and follow‑through
Physically capable of: Standing for extended periods, Lifting ">="50 lbs, Wearing PPE and working with hazardous materials
Excellent written and verbal communication skills
Proficient in Microsoft Office (Word, Excel)

Nice To Haves

Associate degree in a scientific or technical discipline
Strong mechanical aptitude with a hands‑on mindset
Experience with DeltaV Production Control System
Experience supporting API manufacturing in a cGMP environment
Hands‑on experience with large‑scale distillation, filtration, drying, or milling operations

Responsibilities

Execute Process Operating Instructions and batch records in a regulated cGMP (GxP) environment.
Prepare, operate, monitor, sample, and clean complex pharmaceutical manufacturing equipment according to SOPs.
Perform hands‑on chemical processing activities, including solid and liquid charging, atmospheric and vacuum distillation, liquid‑liquid extractions and phase separations, crystallization, filtration, milling, and drying.
Perform routine manual material handling, including lifting and moving loads ">="50 lbs using proper safety techniques.
Identify, troubleshoot, and resolve equipment and process issues.
Generate, review, and execute cGMP documentation such as batch records, cleaning records, and in‑process control sampling documentation.
Support equipment commissioning and qualification activities.
Participate in SOP periodic reviews.
Report deviations, observations, or safety concerns that may impact product quality or process safety.
Ensure proper handling, segregation, and disposal of manufacturing waste in compliance with environmental and safety requirements.
Communicate effectively across cross‑functional teams including Quality, Compliance, Process Chemists, Analysts, and Supervisors.
Actively participate in shift handovers and operational communications.
Identify and implement continuous improvement opportunities.
Prioritize personal workload and support less‑experienced colleagues in task planning and execution.
Complete required training and participate in facility safety inspections.