Manufacturing Associate cGMP API Production
Eurofins USA PSS Insourcing Solutions, Groton, CT, United States
Job Description
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 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.
Compensation
$18–$18
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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 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.
Compensation
$18–$18
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