Sterile Operations Supervisor - Full-time

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 works with the biggest companies in the world to ensure the products they supply are safe, their ingredients are authentic and labelling is accurate. Eurofins believes it is a global leader in food, environmental, pharmaceutical and cosmetics products testing and in agroscience CRO services. It is also one of the global independent market leaders in certain testing and laboratory services for genomics, discovery pharmacology, forensics, CDMO, advanced material sciences and in the support of clinical studies.

In over just 30 years, Eurofins has grown from one laboratory in Nantes, France to over 47,000 staff across a network of more than 900 independent companies in over 50 countries and operating more than 800 laboratories. Eurofins offers a portfolio of over 200,000 analytical methods to evaluate the safety, identity, composition, authenticity, origin, traceability and purity of biological substances and products, as well as providing innovative clinical diagnostic testing services, as one of the leading global emerging players in specialised clinical diagnostics testing.

 In 2019, Eurofins generated total revenues of EUR € 4.56 billion, and has been among the best performing stocks in Europe over the past 20 years.

Job Description

• Provide managerial oversight of on-site team personnel
• Attend Sterile team huddles and coordinate applicable work with Sterile Operations, QA and other facility contractors
• Oversee the scheduling of the Building 29 unmanned Environmental Monitoring
• Provides support for investigations, including those surrounding sterile facility incursions or any other investigations associated with the deliverables supporting this task order
• Provides support for any client projects where relevant competencies and skills can be utilized
• Provides editing/authoring support in the client documentation system for all document types except SOPs
• Orders and manages the Microbiological consumables
• Recommends and implements improvements for training documentation for TEAM staff
• Addresses group local audit findings where applicable and provides support during on-site audits
• Documents data as dictated by current client policies and procedures
• Collects and measures TEAM productivity through agreed upon metrics. These metrics will be supplied to client
• Management on a monthly basis, unless agreed to otherwise
• Attends meetings with client as required
• While onsite, will also find ways through process improvements and best practices to support productivity initiatives. client will provide workers access to a desk, computer, phone, SOP/method training, where applicable, and access to client systems as necessary.
• Performs Microbiological testing of the facility, as needed
• Provides support for product testing, including administration of third party testing (e.g. bioburden, sterility testing, bacterial endotoxin testing, container closure integrity), sample tracking, and documentation archiving using LabWare
• Provides input, as needed, for productivity improvements related to product testing (e.g. new technologies)
• Manages calibration, maintenance, and alarm monitoring for laboratory equipment and instruments, coordinating with the appropriate support groups for these activities.
• Responsible for sampling/testing compliance checks to ensure that samples are taken, tested, and read according to schedule.
• Review of team-produced data, when applicable
• Authoring/reviewing of team procedures/methods, when applicable

Qualifications

• Bachelor's degree in biology, microbiology, or other related science
• 5+ years microbiological experience with data review/regulatory exposure
• Experience working in a sterile manufacturing facility environment requiring Aseptic Technique
• 3+ years of people management experience
• Strong computer, scientific, and organizational skills
• High familiarity with compendial procedures (USP, EP)
• Excellent communication (oral and written) and attention to detail
• Ability to work independently flexible hours and as part of a team, self-motivation, adaptability, and a positive attitude
• Ability to learn new techniques, performs multiple tasks simultaneously, keep accurate records, follow instructions, and comply with company policies

Additional Information

Position is full-time, Monday - Friday 7:00am - 4:00pm.  Candidates currently living within a commutable distance of King of Prussia, PA 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

Eurofins is a M/F, Disabled, and Veteran Equal Employment Opportunity and Affirmative Action employer.