API Manufacturing Technician

Company Description

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.

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, which includes these operational tasks: 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 {part of GxP} 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 throughout the work shift, 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 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: Compliance, 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 and cleaning 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 or process safety.
• 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.

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
• Candidate must be physically capable of standing for prolonged periods, able to lift up to or in excess of 50 lbs, be amenable to wearing personal protective equipment and working with hazardous materials.
• Excellent written and verbal communication skills
• Strong computer skills in Microsoft Office required e.g. MS Word, MS 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 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

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
• #LI-EB1

Eurofins USA PSS Insourcing Solutions is a Disabled and Veteran Equal Employment Opportunity employer.