Instrumentation Validation Scientist - Eurofins Lancaster Laboratories Professional Scientific Services, LLC

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

• Responsible for performing validation of computer systems, process automation, equipment, utility systems, and/or facilities by following approved standard operating procedures (SOPs), current Good Manufacturing Practices (GMPs) and all other regulatory requirements including GAMP5.
  

• Executes test plans according to approved procedures, collects samples, tabulates test results, and organizes data packages.
  

• Compiles and analyzes validation data, prepares reports and makes recommendations for changes and/or improvements.
  

• May also investigate and trouble-shoot problems which occur and determine solutions.
  

• Coordinates and executes validation change control and preparation of draft protocols, reports and data tables.
  

• Maintains all documentation pertaining to validation.
  

• Will assist in developing procedures and/or protocols.
  

• Coordinates contract personnel through completion of assignments.
  

• Participates on cross-functional project teams with the support of Development, Manufacturing, Engineering, Quality, and other groups as required.
  

• May provide day-to-day guidance and training to other validation technicians.
  

• Serves as an information resource to validation technicians, contractors and vendors.
  

• Resolves validation issues of moderate scope with limited direct supervision.
  

Qualifications

• A High School Diploma with 6+ years of relative experience OR an Associates Degree with 5+ years of relevant experience OR A Bachelor's Degree with 4+ years of relevant experience or a Master's Degree (M.S./MBA) with 2+ years of relevant experience.
  

• Understanding and application of validation principles, concepts, practices, and standards.
  

• Working knowledge of current Good Manufacturing Practices (GMPs).
  

• Previous experience with Computer System Validation (CSV) and experience with System Development Life Cycle of automated computer systems within biopharmaceutical environments.
  

• Working knowledge of validation of process control (PCS) and data acquisition systems is preferred.
  

• Previous experience having worked in a GMP Clinical Manufacturing facility is preferred.
  

• Strong verbal, written, and interpersonal communication skills.
  

• Proficient in Microsoft Office applications.
  

Additional Information

Position is full-time with overtime as needed. Candidates currently living within a commutable distance ofOceanside, CAare encouraged to apply.

What we offer:

• 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
  

• Compensation Range: $55,000 - $65,000
  

Eurofins Lancaster