Senior Process Validation Specialist

Are you ready to validate processes that power innovation? Join our client and ensure every process meets the highest standards of pharmaceutical excellence!

Proclinical is seeking a Process Validation Specialist for a Senior position to focus on process validation within biotechnology processes. This position emphasizes large-scale mammalian processes and requires immediate attention to developing validation strategies and ensuring compliance with industry standards.

Please note that to be considered for this role you must have the right to work in this location or hold an EU passport.

Responsibilities:

• Develop strategies for process-specific validations in biotechnology, focusing on large-scale mammalian processes.
• Create and manage process validation protocols and reports, including studies on hold times, resin lifetimes, and buffer holds.
• Participate in or lead cross-functional risk assessments to define validation scopes.
• Evaluate validation data against protocol criteria and address deviations with corrective measures.
• Collaborate with Quality Assurance (QA) to standardize validation documents and ensure compliance.
• Review and approve project-related documents and records, including risk assessments and technical change requests.
• Coordinate with QA Ops for batch release processes, including deviation report approvals.
• Prepare, process, and approve Continued Process Verification (CPV) plans and reports.
• Assist in process development during characterization studies and risk assessments.
• Lead cross-functional technical project teams and organize collaborative meetings.
• Serve as a contact for process validation during inspections and audits.
• Support validation training programs and mentor junior team members.
• Promote a culture of continuous improvement within the organization.

Key Skills and Requirements:

• Strong expertise in process validation within biotechnology.
• Ability to develop and implement validation strategies.
• Proficiency in creating and managing validation documentation.
• Experience in risk assessment and deviation management.
• Collaborative skills for working with cross-functional teams.
• Effective communication skills for inspections and audits.
• Commitment to continuous improvement and mentoring.

If you are having difficulty in applying or if you have any questions, please contact Ashley Bennett at a.bennett@proclinical.com.

If you are interested in applying to this exciting opportunity, then please click 'Apply' or to speak to one of our specialists please request a call back at the top of this page.

Proclinical is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Proclinical is acting as an Employment Agency in relation to this vacancy.

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