Manufacturing Associate cGMP API Production
Eurofins, Groton, CT, United States
Manufacturing Associate
cGMP API Production
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 include:
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 includes:
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 includes:
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 include:
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 include:
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 includes:
After the initial training period of approximately 3 months which will be Monday-Friday from 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 pm
2nd Shift is Mon
Thurs, 2 pm to 12 pm
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.
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
Eurofins USA PSS Insourcing Solutions is a Disabled and Veteran Equal Employment Opportunity employer.
cGMP API Production
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 include:
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 includes:
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 includes:
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 include:
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 include:
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 includes:
After the initial training period of approximately 3 months which will be Monday-Friday from 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 pm
2nd Shift is Mon
Thurs, 2 pm to 12 pm
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.
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
Eurofins USA PSS Insourcing Solutions is a Disabled and Veteran Equal Employment Opportunity employer.