Facility Validation Engineer

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Job Details

Location
Darlington, England
Salary
£32,000 - £42,400 per annum - dependent on experience
Employment
Full-time - Permanent
Team
Science and Engineering
Deadline
05 Dec 2021 - 23:30
Reference
CPI-3902-21
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About CPI

At CPI we work with our partners to translate inventions into products and processes that enhance health and well-being, protect and improve our environment and increase productivity across industries.

With a deep understanding of innovation processes and funding, outstanding technical expertise and industry relevant assets, we enable products and processes to be quickly and cost-effectively brought to market. This supports the development of next-generation manufacturing, highly-skilled jobs and economic growth for the UK.

Our partners operate across many diverse markets including pharmaceuticals, speciality chemicals, food and drink, electronics and transportation.

Why this role is important for CPI’s work

CPI has a newly created opportunity for an experienced Facility Validation Engineer to the growing CPI Biologics Operations team based at Darlington. The team span GMP, Operations, Bioengineering including Validation and Technical Operation. Working together they manage and sustain CPI’s Biologics platform operations, to meet objectives of promoting innovation and manufacturing of Biologics and Vaccines at CPI and for our customers.

Reporting to the Head of Operations – Vaccines & GMP you will work at multiple CPI sites in Darlington, including the new RNA Centre of Excellence and the NBMC Facility, and will ensure the sites Validation is maintained for both Biologics and Vaccine GMP manufacturing. You will maintain site validation master plans for CPI Biologics GMP sites and ongoing GMP compliance, planning, and carrying out validation activities and reviews per the plans. You will also collect and analyse data to make improvements to validations activities, planning, investigating, and resolving issues relating to validation of CPI Biologics GMP facilities and equipment.

The Facility Validation Engineer will also manage validation work to maintain consistent and documented compliance, with all relevant Safety, Health and Environmental (SHE), Quality, and best practice requirements. You will build and maintain a network of relevant internal stakeholders, to represent yourself and the wider team as credible professionals in networks and groups. You will keep up to date with developments in areas relevant to the role and/​or legislative and SHE related changes, ensuring understanding of these and any associated new best practice, method, or techniques.

Read more about the RNA Centre of Excellence and NBMC Facility using the below links

RNA Centre of Excellence

https://​www​.uk​-cpi​.com/​n​e​w​s​/​g​r​o​u​n​d​-​b​r​o​k​e​n​-​c​p​i​s​-​n​a​t​i​o​n​a​l​-​b​i​o​l​o​g​i​c​s​-​m​a​n​u​f​a​c​t​uring

Key responsibilities:

Maintain Site Validation Master Plans required for CPI Biologics cGMP sites at Darlington (specifically Biologics NBMC and the RNA Centre of Excellence sites)

Plan and carry out facility validation activities.

Collect and analyse data to make improvements to the facility validation activities and planning

Investigate and resolve issues relating to the validation of CPI GMP facilities.

Conduct and take part in risk assessments to ensure safety and regulatory requirements, including GMP validation

Manage and optimise costs associated with the validation of CPI GMP facilities

Take part in validation review and approvals of Biologics Operations Validation documentation, including validation phases for design, installation, testing, operation, performance, and ongoing validated status maintenance for Biologics GMP manufacturing operations.

The person we are seeking

It is essential that you are educated to a minimum of HNC or Foundation Degree level (or equivalent) in a discipline related to Facility Validation Engineering and can demonstrate significant industrial experience to match the role requirements.

You are required to have recent demonstrable direct experience in GMP Validation

You must also have experience of working within Grade D & C cleanroom environment for Facility Validation, and experience with Facility HVAC Validation, Environmental Monitoring Systems Validation, and GMP Equipment Re-validation. 

You will be able to demonstrate possess a technical understanding and good underpinning knowledge in facility validation engineering, as well as evidence of technical problem-solving. With the ability to practically apply Facility Validation methods to contribute to ongoing business activities.

What does CPI offer you?

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

  • Up to 36 days holiday, including bank holidays – Plus a holiday purchasing scheme
  • Generous pension scheme
  • Life assurance and accident insurance schemes
  • Flexible working
  • Learning and Development Opportunities
  • Free parking

Find out more about our culture and benefits.

Additional information

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.

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