Validation Specialist

Validation Lead - Pharmaceutical Manufacturing

Smart4 Sciences are recruiting on behalf of a leading pharmaceutical manufacturing and packaging business for an experienced Validation Specialist to join their team at their manufacturing facility in Newcastle. This is an excellent opportunity to take ownership of validation activities across equipment, systems, processes, and facilities, playing a pivotal role in ensuring compliance with regulatory and GMP standards.

Key Responsibilities

• Lead validation activities for the introduction of new facilities, equipment, systems, processes, products, and technologies.
• Generate and control validation documentation (URS, FAT/SAT, FDS, DQ, IQ, OQ, PQ, and validation reports).
• Maintain site validation status, ensuring all assets remain in a validated state.
• Prepare validation plans, protocols, and reports for equipment, systems, and software.
• Conduct validation studies and develop project scopes aligned with business needs.
• Manage the site''s Validation Master Plan.
• Act as subject matter expert for validation and qualification activities.
• Liaise with customers for new product introductions and re-validations.
• Support ongoing process verification activities and ensure timely completion of CAPAs and change controls.

About You

• Proven experience in validation within a GMP-regulated pharmaceutical or life sciences environment.
• Strong understanding of the full validation lifecycle and regulatory requirements.
• Experience with Computer Systems Validation.
• Confident in Microsoft Office applications.
• Excellent communication skills and the ability to work both independently and as part of a team.
• Scientific or engineering degree (or equivalent industry experience).
• Willingness to travel domestically and internationally as required.

If you have the skills and experience to excel in this Validation Specialist role please apply today or contact Gareth Gooley on for more information