Hobson Prior is seeking a Validation Support Specialist for a managerial role. This role is crucial in ensuring that the manufacturing site meets all necessary qualification and validation regulations. The successful candidate will provide validation expertise across the manufacturing facility and laboratories, ensuring all systems, equipment, facilities, utilities and processes are appropriately validated and qualified.

Please note that to be considered for this role you must have the right to work in this location.

Responsibilities:

• Create and update the site Master validation plan.
• Act as the main participant during site audits and inspections, explaining all site Validation activities to regulators.
• Collaborate with other departments to ensure validation project plans align with site objectives.
• Generate, review, and approve validation, qualification, plans, protocols, and reports.
• Work with external consultants, suppliers, and contractors to ensure successful utility and equipment validations.
• Write or assist in writing/reviewing of Validation Policies, Validation SOPS/Templates for the site.
• Coordinate, track, and report all Validation and qualification activities across projects and routine operations.
• Propose corrective actions to avoid delays and optimize the schedule for qualification/validation activities for the site.
• Aid in investigations and troubleshooting as part of a multi-functional team.
• Coach validation team members regarding validation/qualification best practices.
• Review completed qualification and validation protocols, summary reports, and associated data for conformance to regulations, SOPs, specifications, and other applicable acceptance criteria.

Key Skills and Requirements:

• Proven track record in delivering robust and regulatory compliant Validation Plans and Protocols.
• In-depth working knowledge of regulatory requirements.
• Experience in communicating with regulators during site regulatory inspections.
• Good interpersonal skills.
• Good organisational and time management skills.
• BSc/MSc or BEng/MEng in Engineering or related discipline.
• Experience in multiple GMP validation disciplines (process equipment, utility, automation, computer systems, sterilization) with advanced technical knowledge.
• Experience with managing teams in a GMP manufacturing environment.

For more information, please contact William Hay.

Apply now:

If you are interested in learning more or applying to this exciting opportunity then please click Apply and upload a copy of your CV. Alternatively for further details or to talk directly to a life sciences recruitment specialist directly please select Contact me at the top of this page.

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

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