API Manufacturing Technician
Eurofins PSS Insourcing Solutions, New London, CT, United States
Overview
Eurofins Scientific is an international life sciences company providing analytical testing services to clients across multiple industries to make life and our environment safer, healthier and more sustainable. From the food you eat, to the water you drink, to the medicines you rely on, Eurofins laboratories work with the biggest companies in the world to ensure the products they supply are safe, their ingredients are authentic and labelling is accurate.
The Eurofins network is a global leader in food, environment, pharmaceutical and cosmetic product testing and in agroscience Contract Research Organisation services. It has a rapidly developing presence in highly specialised and molecular clinical diagnostic testing and in-vitro diagnostic products. Eurofins has grown from one laboratory in Nantes, France to a large global network with tens of thousands of staff and laboratories in many countries, offering a portfolio of analytical methods to evaluate safety, identity, composition, authenticity, origin, traceability and purity of biological substances and products.
Job Description
You will be part of a multi-disciplinary team responsible for the Current Good Manufacturing Practices (cGMP) production of non-commercial size clinical batches supporting Active Pharmaceutical Ingredient (API) development. This includes but is not limited to: supporting the manufacturing operations team, reviewing Standard Operating Procedures, executing batch records, and supporting commissioning and qualification of process equipment. Standard work will involve chemical synthesis of API, including operations such as solid/liquid charges to vessels, atmospheric/vacuum distillations, liquid-liquid extractions, phase cut, crystallization, filtrations and drying.
Role Responsibilities
Execute Process Operating Instructions in a cGMP environment.
Responsible for equipment preparation, operational adjustment, process monitoring, sampling, and equipment cleaning of complex pharmaceutical manufacturing equipment as defined in standard operating procedures.
Perform manual handling tasks, including lifting, carrying and moving objects weighing up to and exceeding 50 pounds on a routine basis, using proper material-handling techniques and safety practices.
Handle and segregate manufacturing waste in accordance with approved waste management, environmental, and safety requirements.
Support equipment qualification/commissioning activities.
Adhere to cGMP and standard and local operating procedure requirements.
Complete recurring assignments independently and select the most appropriate method within prescribed limits of authority.
Identify opportunities for continuous improvements and enable implementation.
Maintain cross-functional communication with tech transfer team: Compliance, Quality, Process Chemists, Analysts, and Process Supervisors.
Perform troubleshooting of manufacturing support equipment and operations.
Generate, assist, and execute documentation associated with cGMP API manufacture, such as working batch records, cleaning documentation and in-process control sampling.
Support Standard Operating Procedure periodic reviews.
Report deviations or observations that might impact product quality or process safety.
Participate in shift exchange activities and communication channels.
Complete training to take part in safety inspections within the facility.
Manage own time, professional development, and be accountable for own results.
Prioritize own workflow and assist in prioritizing the workflow of less-experienced colleagues.
Qualifications
BASIC MINIMUM QUALIFICATIONS
High School Diploma or GED
4+ years of relative experience
Demonstrated experience in a cGMP manufacturing environment.
Operational knowledge of Production Control Systems
Ability to think critically and demonstrate troubleshooting and problem-solving skills
Strong workload planning skills, organization, attention to detail, and follow through
Demonstrated capability to work as an independent contributor within a matrix development team
Physically capable of standing for prolonged periods, able to lift up to or in excess of 50 lbs, amenable to wearing PPE and working with hazardous materials
Excellent written and verbal communication skills
Strong computer skills in Microsoft Office (Word, Excel)
Authorization to work in the United States indefinitely without restriction or sponsorship
PREFERRED QUALIFICATIONS
Associate degree (Science or technical discipline)
Strong mechanical aptitude and desire to perform hands-on manual labor
Experience with DeltaV Production Control System
Experience in a Pharmaceutical cGMP manufacturing environment
Experience performing large-scale distillations, filtrations, or milling
Additional Information
After the initial training period (approximately 3 months), shift schedules may move to 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 requested to work on weekends, overtime, and holidays based on business needs.
Candidates living within 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; and paid vacation and holidays.
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 providing analytical testing services to clients across multiple industries to make life and our environment safer, healthier and more sustainable. From the food you eat, to the water you drink, to the medicines you rely on, Eurofins laboratories work with the biggest companies in the world to ensure the products they supply are safe, their ingredients are authentic and labelling is accurate.
The Eurofins network is a global leader in food, environment, pharmaceutical and cosmetic product testing and in agroscience Contract Research Organisation services. It has a rapidly developing presence in highly specialised and molecular clinical diagnostic testing and in-vitro diagnostic products. Eurofins has grown from one laboratory in Nantes, France to a large global network with tens of thousands of staff and laboratories in many countries, offering a portfolio of analytical methods to evaluate safety, identity, composition, authenticity, origin, traceability and purity of biological substances and products.
Job Description
You will be part of a multi-disciplinary team responsible for the Current Good Manufacturing Practices (cGMP) production of non-commercial size clinical batches supporting Active Pharmaceutical Ingredient (API) development. This includes but is not limited to: supporting the manufacturing operations team, reviewing Standard Operating Procedures, executing batch records, and supporting commissioning and qualification of process equipment. Standard work will involve chemical synthesis of API, including operations such as solid/liquid charges to vessels, atmospheric/vacuum distillations, liquid-liquid extractions, phase cut, crystallization, filtrations and drying.
Role Responsibilities
Execute Process Operating Instructions in a cGMP environment.
Responsible for equipment preparation, operational adjustment, process monitoring, sampling, and equipment cleaning of complex pharmaceutical manufacturing equipment as defined in standard operating procedures.
Perform manual handling tasks, including lifting, carrying and moving objects weighing up to and exceeding 50 pounds on a routine basis, using proper material-handling techniques and safety practices.
Handle and segregate manufacturing waste in accordance with approved waste management, environmental, and safety requirements.
Support equipment qualification/commissioning activities.
Adhere to cGMP and standard and local operating procedure requirements.
Complete recurring assignments independently and select the most appropriate method within prescribed limits of authority.
Identify opportunities for continuous improvements and enable implementation.
Maintain cross-functional communication with tech transfer team: Compliance, Quality, Process Chemists, Analysts, and Process Supervisors.
Perform troubleshooting of manufacturing support equipment and operations.
Generate, assist, and execute documentation associated with cGMP API manufacture, such as working batch records, cleaning documentation and in-process control sampling.
Support Standard Operating Procedure periodic reviews.
Report deviations or observations that might impact product quality or process safety.
Participate in shift exchange activities and communication channels.
Complete training to take part in safety inspections within the facility.
Manage own time, professional development, and be accountable for own results.
Prioritize own workflow and assist in prioritizing the workflow of less-experienced colleagues.
Qualifications
BASIC MINIMUM QUALIFICATIONS
High School Diploma or GED
4+ years of relative experience
Demonstrated experience in a cGMP manufacturing environment.
Operational knowledge of Production Control Systems
Ability to think critically and demonstrate troubleshooting and problem-solving skills
Strong workload planning skills, organization, attention to detail, and follow through
Demonstrated capability to work as an independent contributor within a matrix development team
Physically capable of standing for prolonged periods, able to lift up to or in excess of 50 lbs, amenable to wearing PPE and working with hazardous materials
Excellent written and verbal communication skills
Strong computer skills in Microsoft Office (Word, Excel)
Authorization to work in the United States indefinitely without restriction or sponsorship
PREFERRED QUALIFICATIONS
Associate degree (Science or technical discipline)
Strong mechanical aptitude and desire to perform hands-on manual labor
Experience with DeltaV Production Control System
Experience in a Pharmaceutical cGMP manufacturing environment
Experience performing large-scale distillations, filtrations, or milling
Additional Information
After the initial training period (approximately 3 months), shift schedules may move to 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 requested to work on weekends, overtime, and holidays based on business needs.
Candidates living within 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; and paid vacation and holidays.
Eurofins USA PSS Insourcing Solutions is a Disabled and Veteran Equal Employment Opportunity employer.
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