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.
Essential Duties and Responsibilities:
- 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.
To perform this job successfully, the individual must be able to perform each essential duty satisfactorily. The requirements below are representative of the knowledge, skill or ability required.
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.
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.
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Eurofins is a M/F, Disabled, and Veteran Equal Employment Opportunity and Affirmative Action employer.
