Validation Manager

1 month ago

Columbia, United States Eurofins USA BioPharma Services Full time
Job DescriptionJob DescriptionCompany 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 labeling 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 2020, Eurofins generated total revenues of EUR € 5.4 billion, and has been among the best performing stocks in Europe over the past 20 years.

Eurofins BioPharma Product Testing has delivered expert scientific support to companies working to improve human and animal health. As a member of the Eurofins BPT team, you will work alongside respected technical experts dedicated to scientific excellence in a process driven regulatory compliant environment.  

Job Description

The Validation Manager will be responsible to provide quality support and oversight for GMP software validation activities and to maintain data integrity standards as per 21CFR Parts 210, 211, 11, and ensuring compliance with relevant regulatory requirements and industry standards/best practices.

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Essential Duties and Responsibilities include:

  • The responsibilities for Manager may include but are not limited to the following activities: Provide Quality oversight of Computer System Validation, Computer Software Assurance activities related to initial implementations, changes, periodic review, maintenance, and decommissioning of systems.
  • Execute and manage risk assessment, planning, and execution/mitigation activities to ensure computerized systems used to support operations are maintained in a qualified state throughout their lifecycles.
  • Participate in project teams to provide guidance and approval of project Validation documentation and relevant Change Controls.
  • Manage the software-based data integrity program, including the timeline of activities for data integrity deliverables (e.g., data integrity assessments, CAPA actions, remediations etc.).
  • Author and/or review and approve relevant GMP software validation documentation.
  • Deliver training on validation and data integrity principles/requirements to foster employee awareness and accountability.
  • Create and/or revise SOPs supporting validation and data integrity activities.
  • Stay technologically current, investigate new technology and instrumentation; act as a technical resource for internal problems and projects; stay current with regulatory requirements; interpret regulations and coordinate implementation of new internal programs and procedures.
  • Development of budget, monitor expenses, look for cost-saving applications; provide routine departmental business review updates to executive management.
Qualifications

Minimum Qualifications:

  • Bachelor's degree in a scientific or technical discipline, GMP Software Validation, or Lab Scientist role in the biotechnology/pharmaceutical industry with at least 2 years' experience with computer systems validation.

  • Minimum of five years’ experience in biotechnology/pharmaceutical industry.

  • Experience with GMP validation methodology is required. Strong understanding of 21 CFR Part 11, EU Annex 11 regulations, applications and best practices is required.

  • Previous Supervisory or Management experience required.

  • The successful candidate will possess a strong attention to detail while having the ability to set priorities and meet aggressive timelines.

  • Authorization to work in the United States indefinitely without restriction or sponsorship.

The ideal candidate would possess:

  • Strong computer, scientific, and organizational skills.
  • Excellent communication (oral and written) and attention to detail.
  • Ability to read, analyze, and interpret the most complex documents.  Ability to respond effectively to the most sensitive inquiries or complaints.  Ability to write speeches and articles using original or innovative techniques or style.  Ability to make effective and persuasive speeches and presentations on controversial or complex topics to top management, public groups, and/or boards of directors.
  • Ability to apply principles of logical or scientific thinking to a wide range of intellectual and practical problems.  Ability to deal with nonverbal symbolism (formulas, scientific equations, graphs, musical notes, etc.,) in its most difficult phases.  Ability to deal with a variety of abstract and concrete variables.
  • Ability to apply critical thinking when developing validation documentation, working with laboratory systems and managing all aspect of the position.
  • Ability to learn new techniques, perform multiple tasks simultaneously, keep accurate records, follow instructions, and comply with company policies.
  • To perform this job successfully, an individual will need to gain knowledge of a variety of laboratory software systems, spreadsheet software, and word Processing software.
  • Ability to work independently and as part of a team, self-motivation, adaptability, and a positive attitude.


Additional Information

Position is full-time, Monday-Friday, 8 a.m.-4:30 p.m., with overtime as needed.  Candidates currently living within a commutable distance of Columbia, MO are encouraged to apply.

As a Eurofins employee, you will become part of a company that has received national recognition as a great place to work.  We offer excellent full-time benefits including comprehensive medical coverage, life and disability insurance, 401(k) with company match, paid holidays and PTO, and dental and vision options.

To learn more about Eurofins, please explore our website www.eurofinsus.com.

We are looking forward to receiving your application including your expected salary and possible start date via our career website.

#LI-EB1 

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

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