Validation Process Supervisor

Vor 2 Tagen

Fribourg, Schweiz Bio-Rad Laboratories Vollzeit

Overview:
Founded in 1952, Bio-Rad has developed into a recognized global leader in the growing life science research and clinical diagnostics markets. We’ve built a strong team of over 8,000 employees and a robust network of operations that serves over 150,000 customers worldwide. Bio-Rad employees share a common mission: To “Advance discovery and improve lives.” It’s who we are and what we do.

In order to support Bio-Rad and our successful future growth we are seeking a highly motivated and experienced individual to join our team as a

**Process Validation Supervisor (M/F/d) 100%**

**Responsibilities**:
The Process Validation supervisor is responsible for establishment and ownership of the manufacturing Quality Management System. Validation ensuring a specific approach, compliant to regulatory requirements and industry standards. The role develops, establishes, and maintains Validation Master Plans and is accountable of the validation strategy definition in the area of responsibility. Responsible for the technical and scientific content relating to validation activities with an emphasis in risk-based, technical-based approaches to Process Validation and to current Good Manufacturing Practices.
- Manage the validation team (4-6 collaborators)
- Develops and controls the staffing plan
- Plans, aligns and executes the team objectives and controls the achievement of associated targets / indicators / metrics
- Continuously develops the Validation team through training, further education, coaching and delegation of duties
- Establishes and keeps updated the Quality management system elements (Policies, SOPs, Forms, others) governing Cleaning-, - and Process Validation including all ancillary Process Validation activities and Continuous Process Verification (CPV)
- Ensures implementation of and adherence to current GMP, FDA rules, Quality policies, procedures and instructions for the area of responsibility
- Ensures transfer of New Product from Product Development into routine manufacturing; act as the main contact person for all project stakeholders
- Support of the technical departments in the context of authority queries and audits about design verification & validation and technical support/advice of the interfaces in connection with design verification & validation activities

Qualifications:

- Degree (Bachelor, Masters or higher) in Life Sciences (Biology, Chemistry, etc.), Dipl. Ing. or M.Sc. or B.Sc. or equivalent
- 5+ years of experience as Validation Lead
- Work experience with standards such as 21 CFR 820, 21 CFR 11, and ISO 13485
- Proven scientific and technical expertise in Qualification, Process and Cleaning Validation, Analytical Method Validation in Diagnostic/Pharmaceutical industry
- Leadership skills and experience in technical management within a matrix environment
- Ability to work across multi-discipline teams
- French and English (fluent), German (basic)

To all recruitment agencies: Bio-Rad does not accept agency resumes, unless the agency has been authorized by a Bio-Rad Staffing Representative. Please do not submit resumes unless authorized to do so. Bio-Rad will not pay for any fees related to unsolicited resumes.

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