Senior Process Validation Specialist (m/f/d)
Responsibilities
- Develop the strategy for the process-specific validations in biotechnology processes with focus on Mammalian Large Scale (ORCA) / Issue process validation/ study protocols and reports following VMP and SOPs (e.g. hold time studies, resin lifetime studies, buffer hold studies mixing studies, etc.)
- Participate in or moderate cross-functional Risk Assessments (RA) to define the scope of validation/ study activities / Assess validation data for conformance to protocol acceptance criteria and support the investigation and evaluation of deviations from the plans as well as the definition of associated corrective measures
- Collaborate with QA in the definition of the standard for content, wording and scope of the validation documents and ensure that all validation documents comply with this standard
- Issue, review or approve project related documents (RA, , TT documents, FMEA, etc.) and records (DR, CR, TCR)
- Assessment of validation related technical change requests (TCR) and process-specific change requests (CR). Assessment of whether additional / new validation is required
- Ensure the collaboration with QA Ops for batch release of process in validation, inclusive the approval of deviation reports and change request of validated processes
- Coordinates preparation, processing, control and approval of CPV plans, CPV reports and PQRs as process validation specialist
- Assist process development (PD) during process characterization studies and risk assessments
- Act as a key member (i.e. technical lead) in cross-functional technical project teams and ensure the organization of meetings for an efficient collaboration with MSAT, QA Validation, Cleaning Validation and QA Qualification (as required)
- Support (as requested) the establishment of a culture of continuous improvement throughout the organization
Profile
- Bachelor’s or Master’s degree in Biotechnology, Biochemical Engineering, Pharmaceutical Sciences, Chemistry, or a related field
- Experience in process validation within the biopharmaceutical or biotechnology industry, preferably in large-scale mammalian cell culture processes
- Profound Trackwise (QMS) system Knowledge
- Strong expertise in process validation, risk assessment, and regulatory compliance
- Strong knowledge of Good Manufacturing Practices (GMP), FDA, EMA, and ICH guidelines
- Expertise in risk assessment methodologies (e.g., FMEA, HACCP) and ability to define validation scopes / Ability to analyze validation data, assess deviations, and define corrective actions
- Experience in technical change request (TCR) and process-specific change request (CR) assessments
- Familiarity with Continued Process Verification (CPV) plans, CPV reports, and Product Quality Reviews (PQRs)
- Excellent communication and collaboration skills to work with MSAT, QA Validation, Cleaning Validation, and QA Qualification teams
- Ability to moderate and participate in risk assessments to define validation strategies / Ability to represent process validation during inspections by authorities and customer audits
Benefits
- A very renowned company
- Dynamic and innovative market environment
- Relaxed housing market
- You will work in an international environment
- Good infrastructure
About Hays
With over 15 years of experience in the pharmaceutical and chemical industry as well as in biotechnology and medical engineering, we know the key contacts at companies that are recruiting for challenging jobs with real potential. The current high demand for staff has opened up exciting opportunities for dedicated experts who want to develop professionally and to further their careers. As recruitment specialists with an international network of contacts, we can offer you decisive advantages – completely free of charge. Register with us and reap the benefits of interesting job offers that match your skills and experience.
Staffing process for freelance specialists
- Analysis of qualifications
- Telephone or personal interview
- Contact with customers
- Contract with Hays
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1. Analysis of qualifications
We carry out a detailed analysis of your technical qualifications on the basis of your CV, your application documents and your profile.
Contact at Hays
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