Manufacturing Associate – cGMP API Production
Eurofins Viracor BioPharma Services, New London, CT, United States
Overview
Eurofins Scientific is an international life sciences company providing analytical testing services across multiple industries. The organisation supports the safety, authenticity, and labeling of products through a broad portfolio of analytical methods and global laboratory services.
Position
cGMP Production of non‑commercial clinical API batches
– hands‑on, process‑driven role in a pilot‑scale manufacturing environment. The position supports API development by executing batch operations, assisting with equipment qualification, and ensuring compliance with cGMP and safety standards. Collaboration occurs across Quality, Compliance, and technical teams.
Responsibilities
Manufacturing Operations: Execute Process Operating Instructions and batch records in a regulated cGMP (GxP) environment.
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
Manual material handling as required (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, including 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.
Collaboration & Continuous Improvement: Communicate effectively across cross‑functional teams and participate in shift handovers and operational communications.
Identify and implement continuous improvement opportunities and support less‑experienced colleagues in task planning.
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 (~3 months, Monday–Friday 8am–5pm) team members move to a swing shift (alternating between 1st and 2nd shifts).
1st Shift: Mon-Fri, 6:00 am to 2:00 pm
2nd Shift: Mon–Thu, 2:00 pm to 12:00 am
May be required to work 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 medical, dental, and vision coverage; life and disability insurance; 401(k) with company match; paid vacation and holidays; and authorization to work in the United States without sponsorship.
EEO Notice : Eurofins USA PSS Insourcing Solutions is a Disabled and Veteran Equal Employment Opportunity employer.
#J-18808-Ljbffr
Eurofins Scientific is an international life sciences company providing analytical testing services across multiple industries. The organisation supports the safety, authenticity, and labeling of products through a broad portfolio of analytical methods and global laboratory services.
Position
cGMP Production of non‑commercial clinical API batches
– hands‑on, process‑driven role in a pilot‑scale manufacturing environment. The position supports API development by executing batch operations, assisting with equipment qualification, and ensuring compliance with cGMP and safety standards. Collaboration occurs across Quality, Compliance, and technical teams.
Responsibilities
Manufacturing Operations: Execute Process Operating Instructions and batch records in a regulated cGMP (GxP) environment.
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
Manual material handling as required (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, including 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.
Collaboration & Continuous Improvement: Communicate effectively across cross‑functional teams and participate in shift handovers and operational communications.
Identify and implement continuous improvement opportunities and support less‑experienced colleagues in task planning.
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 (~3 months, Monday–Friday 8am–5pm) team members move to a swing shift (alternating between 1st and 2nd shifts).
1st Shift: Mon-Fri, 6:00 am to 2:00 pm
2nd Shift: Mon–Thu, 2:00 pm to 12:00 am
May be required to work 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 medical, dental, and vision coverage; life and disability insurance; 401(k) with company match; paid vacation and holidays; and authorization to work in the United States without sponsorship.
EEO Notice : Eurofins USA PSS Insourcing Solutions is a Disabled and Veteran Equal Employment Opportunity employer.
#J-18808-Ljbffr