Facility Validation Engineer

Centre for Process Innovation; Tees Valley; On-site; GBP 45,000 - 65,000; Full time

Job summary

A leading biotechnology organization in Tees Valley is hiring a Facility Validation Engineer. This role is vital for ensuring compliance and operational efficiency in state-of-the-art facilities. Responsibilities include maintaining Validation Master Plans, conducting validations, and collaborating cross-functionally to deliver projects. Candidates should have significant experience in GMP principles and validation methodologies, preferably with HVAC and environmental monitoring systems. Join a collaborative team to enhance processes and support regulatory compliance.

Qualifications

• Proven industry experience in GMP principles and validation methodologies.
• Strong working knowledge of regulatory guidelines such as EU GMP Annex 1.
• Hands-on experience in drafting and executing validation protocols.

Responsibilities

• Maintain Site Validation Master Plans for GMP facilities.
• Plan and carry out facility/utilities/equipment validation activities.
• Conduct risk assessments to ensure compliance and safety.

Skills

GMP principles

Validation methodologies

Problem-solving

Collaboration

Data analysis

Education

HNC/Foundation Degree in Engineering or related discipline

Tools

HVAC systems

Environmental monitoring systems

Job description

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.