The Role
CPI are looking to appoint a Facility Validation Engineer to play a critical role in ensuring our GMP Biologics facilities meet the highest standards of compliance, safety, and operational efficiency. You will be responsible for planning, executing, and maintaining validation activities across our state‑of‑the‑art sites, including Darlington’s RNA Centre of Excellence. This position is ideal for someone who thrives in a regulated environment and enjoys problem‑solving, continuous improvement, and collaboration.
Key Responsibilities
* Maintain Site Validation Master Plans for CPI Biologics GMP facilities.
* Plan and carry out facility/utilities/equipment validation activities in line with documented plans.
* Collect and analyse data to improve validation processes and planning.
* Investigate and resolve issues related to facility validation.
* Conduct risk assessments to ensure safety and regulatory compliance.
* Manage and optimise costs associated with validation activities.
* Author, review and approve validation lifecycle documentation (including periodic reviews) for GMP manufacturing operations.
* Working with vendors, contractors and facility management.
* Manage changes and deviations and support internal and external audits and regulatory inspections (i.e. MHRA) as a subject matter expert.
* Collaborate cross‑functionally with Quality, Facility management and Operations to ensure seamless project delivery.
The Person
The person we are seeking
Essential
* Educated to HNC/Foundation Degree level (or equivalent) in Engineering or related discipline, plus significant industrial experience.
* Proven industry experience in GMP principles and validation methodologies within a pharmaceutical/Biotec sector.
* Strong working knowledge of regulatory guidelines i.e. EU GMP Annex 1, ISO standards.
* Technical knowledge and experience in facility/utilities/equipment validation, including HVAC, compressed air, freezers, and environmental monitoring systems.
* Experience working in Grade C & D cleanroom environments.
* Ability to apply theoretical and practical validation methods and solve technical problems.
* Hands‑on experience in drafting and executing validation protocols and documenting findings clearly and concisely.
* Ability to work individually and within a team, taking initiative and managing personal workload to meet targets and deadlines.
Desirable
* Degree or Master’s level qualification in a relevant discipline.
* Chartered (or working toward) status with a professional institution.
* Experience with validation of gas supply systems, GMP equipment revalidation (e.g. freezers, Water for Injection, autoclaves, etc.) and thermal mapping.
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