Facility Validation Engineer

Centre for Process Innovation Limited; Tees Valley; On-site; GBP 42,000 - 52,000; Full time

Job summary

A leading innovation partner in the UK seeks a Facility Validation Engineer to ensure that GMP Biologics facilities meet the highest standards of compliance and safety. The role involves planning and executing validation activities, conducting risk assessments, and collaborating with different teams to ensure efficient project delivery. Candidates should possess a strong background in GMP principles and have experience with validation methodologies in the pharmaceutical sector. This position offers a competitive salary, benefits, and opportunities for professional growth.

Benefits

Up to 36 days holiday

Life assurance and accident insurance schemes

Qualifications

• Significant industrial experience in the pharmaceutical/Biotech sector.
• Strong knowledge of EU GMP Annex 1, ISO standards.
• Experience in Grade C & D cleanroom environments.

Responsibilities

• Maintain Site Validation Master Plans for GMP facilities.
• Plan and execute validation activities.
• Conduct risk assessments to ensure compliance.
• Manage cost of validation activities.

Skills

GMP principles

Validation methodologies

Regulatory guidelines

Problem-solving

Team collaboration

Education

HNC / Foundation Degree in Engineering or related discipline

Degree or Master’s level qualification

Tools

HVAC systems

Environmental monitoring systems

GMP equipment

Job description

£42,000-51,200 per annum - dependent on experience

CPI helps make great ideas and inventions areality. We’re ateam of intelligent people using advances in science and technology to solve the biggest global challenges in healthcare and sustainability.

Through our incredible people and innovation infrastructure, we collaborate with our partners in industry, academia, government, and the investment community to accelerate the development and commercialisation of innovative products.

From health technologies and pharmaceuticals to sustainable food and materials innovations, we turn the entrepreneurial spirit and radical thinking of our people and partners into incredible impact that makes our world abetter place.

Why this role is important for CPI’swork

The Role
CPI are looking to appoint a Facility Validation Engineer to play acritical 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 aregulated 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 asubject matter expert
• Collaborate cross-functionally with Quality, Facility management and Operations to ensure seamless project delivery

The Person

The person we are seeking

• 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 consisely
• Ability to work individually and within ateam, taking initiative and managing personal workload to meet targets and deadlines
• 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.

What does CPI offeryou?

At CPI , we offer awide range of benefits to our employees, this includes:

• Up to 36 days holiday, including bank holidays – Plus a holiday purchasing scheme
• Life assurance and accident insurance schemes

CPI is an organisation based in the UK . Commencement of employment is conditional to demonstrating right to work in the UK , sponsorship may be available.

To find out more about how we can work together, please enter your detailsbelow.

CPI is your innovation partner to make your ideas a reality.