Manufacturing Associate – cGMP API Production
Eurofins, New London, CT, United States
Position Overview
You 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.
Key Responsibilities
Manufacturing Operations
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.
Documentation & Compliance
Generate, review, and execute cGMP documentation such as:
Batch records
Cleaning records
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.
Collaboration & Continuous Improvement
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.
Qualifications
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)
Preferred Qualifications
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
Additional Information
After the initial training period of approximately 3 months (Monday‑Friday 8am‑5pm), team members move to swing shift, which alternates between 1st shift and 2nd shift:
1st Shift is Mon‑Fri, 6:00 am to 2:00 pm
2nd Shift is Mon‑Thu, 2:00 pm to 12:00 am
Candidates may be requested to work on weekends, overtime, and holidays based on business needs.
Candidates currently living within a commutable distance of Groton, CT are encouraged to apply.
Additional benefits include 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.
Eurofins USA PSS Insourcing Solutions is a Disabled and Veteran Equal Employment Opportunity employer.
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You 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.
Key Responsibilities
Manufacturing Operations
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.
Documentation & Compliance
Generate, review, and execute cGMP documentation such as:
Batch records
Cleaning records
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.
Collaboration & Continuous Improvement
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.
Qualifications
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)
Preferred Qualifications
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
Additional Information
After the initial training period of approximately 3 months (Monday‑Friday 8am‑5pm), team members move to swing shift, which alternates between 1st shift and 2nd shift:
1st Shift is Mon‑Fri, 6:00 am to 2:00 pm
2nd Shift is Mon‑Thu, 2:00 pm to 12:00 am
Candidates may be requested to work on weekends, overtime, and holidays based on business needs.
Candidates currently living within a commutable distance of Groton, CT are encouraged to apply.
Additional benefits include 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.
Eurofins USA PSS Insourcing Solutions is a Disabled and Veteran Equal Employment Opportunity employer.
#J-18808-Ljbffr