Compliance Engineer - Stevenage
CK Technical is recruiting for a Compliance Engineer to join a company in the biopharma industry at their site based in Stevenage on a permanent basis.
Our client is at the centre of excellence in innovation, with the core purpose of building a world-leading gene therapy sector in the UK as a key part of a global industry. Their mission is to drive the growth of the industry by helping biopharma organisations across the world translate early stage research into commercially viable and investable therapies.
The role is based at our client's site in Stevenage which is easily commutable from London, Luton, Bedford and Milton Keynes.
The main purpose of the role will be to ensure compliance by creating and executing compliance programs, and driving the completion of all associated documentation.
Duties will include to:
- Critically review and approval of maintenance documentation for critical manufacturing equipment.
- Perform regular reviews of the performance of the critical equipment and report adverse trends.
- Perform regular reviews of the critical utilities, these systems include but are not limited to HVAC, Compressed Air, medical gases.
- Drive the close out of Engineering change controls and facility generated deviations.
- Chair the Utilities Review Committee.
- Review and generate CAPA (Corrective Action, Preventative Action) facility improvement plans.
- Manage the insurance inspection schedule and ensure all appropriate records are maintained in preparation for insurance inspections. This includes but is not limited to LOLER (Lifting Operations and Lifting Equipment Regulations), PSSR (Pressure Systems Safety Regulations), and L8 (Legionella).
- Critically review and approve as engineering stakeholder, process validation documentation to ensure GMP compliance requirements.
- Oversee and generate engineering/facility deviations within the Quality Management System (QMS).
- Be the engineering stakeholder for controlled changes managed through the QMS.
- Be the engineering representative for working parties on the modification or replacement of key manufacturing equipment.
- Generate, review and approve engineering operational and maintenance procedures.
- Ensure engineering site systems are compliant and aligned to best practice by keeping up to date with current GEP/GMP guidance and legislation.
- Assess the impact of new regulations on existing systems and formulate strategies to meet required standards.
- Act as engineering SME (Subject Matter Expert) during Regulatory Audits (FDA, MHRA).
To succeed in this role, you will have:
- Further / higher education in either Production, Electrical or Mechanical Engineering.
- Minimum 3-5 years' experience of working in a pharmaceutical API/Biotech manufacturing operation or a regulated environment.
- Minimum 2 years' experience in quality control or laboratory product testing role would be desirable.
For more information or to apply for this position, please contact George Truman or Emily Mills on 01246 457730 or email email@example.com. Alternatively, please click on the link below to apply online now. Please note that your CV should show exact dates of employment (month and year) and any gaps of a month or more should be explained.
CK Group is an Equal Opportunities employer and welcomes applications from all who meet our selection criteria.
If you do not hear back from us within 5 working days of your application for this role, it means that on this occasion you have not been shortlisted for the next stage of the recruitment campaign. Entitlement to work in the EEA is essential. Please quote reference 45493 in all correspondence.