Pharmaceutical Manufacturing Operator

Eurofins • Groton, CT • 5h ago

Eurofins Scientific is an international life sciences company, providing a unique range of 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 of companies is the global leader in food, environment, pharmaceutical and cosmetic product testing and in agroscience Contract Research Organisation services. It is one of the market leaders in certain testing and laboratory services for genomics, discovery pharmacology, forensics, advanced material sciences and in the support of clinical studies, as well as having an emerging global presence in Contract Development and Manufacturing Organisations. It also has a rapidly developing presence in highly specialised and molecular clinical diagnostic testing and in-vitro diagnostic products.

In over 30 years, Eurofins has grown from one laboratory in Nantes, France to 58,000 staff across a decentralised and entrepreneurial network of 900 laboratories in over 54 countries. Eurofins companies offer a portfolio of over 200,000 analytical methods to evaluate the safety, identity, composition, authenticity, origin, traceability and purity of biological substances and products.

In 2021, Eurofins generated total revenues of EUR 6.72 billion, and has been among the best performing stocks in Europe over the past 20 years.

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, which includes: solid / liquid charges, atmospheric / vacuum distillations, filtrations, liquid-liquid extractions, isolations, drying, purification and milling.

ROLE RESPONSIBILITIES

Execute Process Operating Instructions in a cGMP {part of GxP} environment.

Responsible for equipment preparation, and cleaning of complex pharmaceutical manufacturing equipment as defined in standard operating procedures.

Support equipment validation / commissioning activities.

Adhere to cGMP and standard operating procedure requirements.

Complete recurring assignments independently and select the most appropriate method or approach to do so within prescribed limits of authority.

Identify opportunities for continuous improvements and enable implementation.

Maintain cross-functional communication with tech transfer team: Quality, Process Chemists, Analysists, 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 record documentation, and in-process control sampling.

Support Standard Operating Procedure Periodic Reviews.

Report any deviations or observations that might lead to adverse impact on product quality.

Actively 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.

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

Excellent written and verbal communication skills

Strong computer skills in Microsoft Office required e.g. MS Word, MS Excel

PREFERRED QUALIFICATIONS

Associate degree (Science or technical discipline)

Strong mechanical aptitude and desire to execute hands on manual labor

Experience with Delta V Production Control System

Experience in a Pharmaceutical cGMP manufacturing environment

Experience performing large scale distillations / Filtrations / milling

Position is Monday-Friday 8:00 am- 5:00 pm Overtime as needed. Candidates currently living within a commutable distance of Groton, CT are encouraged to apply.

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

LI-EB1

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.

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