Validation Manager

4 weeks ago


South Shields, South Tyneside, United Kingdom RBW Consulting Full time
Position Overview

Validation Manager

RBW Consulting is collaborating with a prominent Contract Development and Manufacturing Organization (CDMO) that operates multiple facilities across the UK. We are currently seeking a Validation Manager to fulfill a newly created role aimed at addressing the growing demand for our services.

This position will focus on the product manufacturing site, where the successful candidate will assume comprehensive responsibility for the validation of equipment, cleaning processes, and computer systems. This includes overseeing the site’s validation master plan and executing specific validation requirements.

Given the commercial focus of the facility, this role will involve regular engagement with regulatory authorities and close collaboration with clients, necessitating a strong understanding of stakeholder management.

The outlook for the organization is promising, with plans to expand services beyond commercial manufacturing into the clinical sector. In recent months, the company has made significant progress in enhancing its project pipeline, making this role a valuable opportunity for career growth.

Essential Qualifications:

· Extensive experience in pharmaceutical validation within a Good Manufacturing Practice (GMP) environment

· Practical expertise in equipment and cleaning validations; knowledge of Computer System Validation (CSV) is a plus

· Proven experience in managing relationships with key stakeholders and regulatory agencies

· Demonstrated history of overseeing and modifying validation master plans

· Flexibility to adapt to various challenges within a medium-sized manufacturing unit

Key Skills:

Validation, Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ), Design Qualification (DQ), commissioning, equipment validation, cleaning validation, engineering, leadership, CSV, quality assurance, manufacturing, GMP, validation protocols, master planning.


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