Compliance Engineer - £40k-£45k - Pharma/ FMCG - Hertfordshire
My client is an expanding organisation who are looking to add a compliance engineer to their ever growing engineering department. The candidate will be experienced in highly regulated manufacturing environment and will have detailed knowledge of equipment specifically utilities such as HVAC and the technical requirements and documentation associated with it. If you are interested in this role and would like to apply call Joseph Tiffin on 0161 868 2214 for more information or apply now via the website.
- Critical review and approval of maintenance documentation for critical manufacturing equipment.
- To perform regular reviews of the performance of the critical equipment and report adverse trends.
- To 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.
- Review and generate CAPA (Corrective Action, Preventative Action) facility improvement plans.
- 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.
- Act as engineering SME (Subject Matter Expert) during Regulatory Audits (FDA, MHRA).
- Formal qualification in engineering, degree is preferable
- Experience working in a highly regulated environment such as pharma, biotech or API manufacture
- Experience reviewing and authoring technical documentation
- Experience in audits with regulatory authorities
- Strong understanding of HSE, Risk analysis and regulatory requirements
your application has been submitted