Pharmaceutical API Technician
Eurofins PSS Insourcing Solutions, New London, CT, United States
About Eurofins Scientific
Eurofins Scientific is an international life sciences company that offers analytical testing services across a wide range of industries, ensuring the safety, authenticity and accuracy of products that affect life and the environment.
Job Summary
You will be part of a multidisciplinary team responsible for the Current Good Manufacturing Practices (cGMP) production of non‑commercial size clinical batches supporting Active Pharmaceutical Ingredient (API) development. Your work will include reviewing SOPs, executing batch records, supporting commissioning and qualification of process equipment and chemical synthesis of API.
Role Responsibilities
Execute Process Operating Instructions in a cGMP environment.
Prepare equipment, adjust operations, monitor processes, sample and clean complex pharmaceutical manufacturing equipment per SOPs.
Handle manual tasks including lifting and moving objects weighing up to or exceeding 50 lbs.
Segregate manufacturing waste according to approved environmental and safety requirements.
Support equipment qualification and commissioning activities.
Adhere to cGMP and local operating procedures.
Complete recurring assignments independently, choosing appropriate methods within authority limits.
Identify continuous improvement opportunities and help implement them.
Maintain cross‑functional communication with the tech transfer team (Compliance, Quality, Process Chemists, Analysts and Process Supervisors).
Troubleshoot manufacturing support equipment and operations.
Manage documentation such as batch records, cleaning records and in‑process sampling.
Assist with SOP periodic reviews.
Report deviations or observations that could affect product quality or process safety.
Participate in shift‑exchange activities and communication channels.
Complete safety inspection training as required.
Manage time, professional development, and be accountable for results.
Prioritize own workflow and help prioritize less‑experienced colleagues.
Basic Minimum Qualifications
High School Diploma or GED.
At least 4 years of relative experience in a cGMP manufacturing environment.
Demonstrated experience in cGMP manufacturing processes.
Operational knowledge of Production Control Systems.
Strong troubleshooting and problem‑solving skills.
Excellent organizational, planning and attention‑to‑detail skills.
Ability to work independently within a matrix development team.
Physical capability to stand for prolonged periods, lift up to or in excess of 50 lbs, and wear PPE when working with hazardous materials.
Excellent written and verbal communication skills.
Strong computer skills in Microsoft Office (Word, Excel).
Preferred Qualifications
Associate degree in Science or a technical discipline.
Strong mechanical aptitude and willingness to perform hands‑on manual labor.
Experience with Delta V Production Control System.
Experience in a Pharmaceutical cGMP manufacturing environment.
Experience performing large‑scale distillations, filtrations, or milling.
Shift Schedule
Initial training: approx. 3 months, Monday‑Friday, 8 am‑5 pm.
Post‑training swing shift alternating 1st shift and 2nd shift.
1st shift: Monday‑Friday, 6 am‑2 pm.
2nd shift: Monday‑Thursday, 2 pm‑12 am.
May require weekend, overtime, and holiday work based on business needs.
Location
Candidates currently living within commuting distance of Groton, CT are encouraged to apply.
Benefits
Comprehensive medical, dental, and vision coverage.
Life and disability insurance.
401(k) with company match.
Paid vacation and holidays.
Full‑time benefits package.
Authorization to work in the United States indefinitely without restriction or sponsorship.
Equal Opportunity Statement
Eurofins USA PSS Insourcing Solutions is a Disabled and Veteran Equal Employment Opportunity employer.
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Eurofins Scientific is an international life sciences company that offers analytical testing services across a wide range of industries, ensuring the safety, authenticity and accuracy of products that affect life and the environment.
Job Summary
You will be part of a multidisciplinary team responsible for the Current Good Manufacturing Practices (cGMP) production of non‑commercial size clinical batches supporting Active Pharmaceutical Ingredient (API) development. Your work will include reviewing SOPs, executing batch records, supporting commissioning and qualification of process equipment and chemical synthesis of API.
Role Responsibilities
Execute Process Operating Instructions in a cGMP environment.
Prepare equipment, adjust operations, monitor processes, sample and clean complex pharmaceutical manufacturing equipment per SOPs.
Handle manual tasks including lifting and moving objects weighing up to or exceeding 50 lbs.
Segregate manufacturing waste according to approved environmental and safety requirements.
Support equipment qualification and commissioning activities.
Adhere to cGMP and local operating procedures.
Complete recurring assignments independently, choosing appropriate methods within authority limits.
Identify continuous improvement opportunities and help implement them.
Maintain cross‑functional communication with the tech transfer team (Compliance, Quality, Process Chemists, Analysts and Process Supervisors).
Troubleshoot manufacturing support equipment and operations.
Manage documentation such as batch records, cleaning records and in‑process sampling.
Assist with SOP periodic reviews.
Report deviations or observations that could affect product quality or process safety.
Participate in shift‑exchange activities and communication channels.
Complete safety inspection training as required.
Manage time, professional development, and be accountable for results.
Prioritize own workflow and help prioritize less‑experienced colleagues.
Basic Minimum Qualifications
High School Diploma or GED.
At least 4 years of relative experience in a cGMP manufacturing environment.
Demonstrated experience in cGMP manufacturing processes.
Operational knowledge of Production Control Systems.
Strong troubleshooting and problem‑solving skills.
Excellent organizational, planning and attention‑to‑detail skills.
Ability to work independently within a matrix development team.
Physical capability to stand for prolonged periods, lift up to or in excess of 50 lbs, and wear PPE when working with hazardous materials.
Excellent written and verbal communication skills.
Strong computer skills in Microsoft Office (Word, Excel).
Preferred Qualifications
Associate degree in Science or a technical discipline.
Strong mechanical aptitude and willingness to perform hands‑on manual labor.
Experience with Delta V Production Control System.
Experience in a Pharmaceutical cGMP manufacturing environment.
Experience performing large‑scale distillations, filtrations, or milling.
Shift Schedule
Initial training: approx. 3 months, Monday‑Friday, 8 am‑5 pm.
Post‑training swing shift alternating 1st shift and 2nd shift.
1st shift: Monday‑Friday, 6 am‑2 pm.
2nd shift: Monday‑Thursday, 2 pm‑12 am.
May require weekend, overtime, and holiday work based on business needs.
Location
Candidates currently living within commuting distance of Groton, CT are encouraged to apply.
Benefits
Comprehensive medical, dental, and vision coverage.
Life and disability insurance.
401(k) with company match.
Paid vacation and holidays.
Full‑time benefits package.
Authorization to work in the United States indefinitely without restriction or sponsorship.
Equal Opportunity Statement
Eurofins USA PSS Insourcing Solutions is a Disabled and Veteran Equal Employment Opportunity employer.
#J-18808-Ljbffr