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Hyper Recruitment Solutions
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Compliance Engineer

Essex, EssexPermanent
Experience Dependent
Job Reference: J5634158
Updated On: 07/12/2020
Status: Open to Applications
Hyper Recruitment Solutions
Sectors: Pharmaceutical, Biotechnology

Skills: Engineering - Maintenance, Engineering - Quality, Engineering - Maintenance - Maintenance Pharma / Biotech Industry

Job Information

Role Overview

We are currently looking for a Compliance Engineer to join a leading Biotechnology business based in the Essex area. As the Compliance Engineer you will be responsible for ensuring site-wide engineering compliance by creating and executing engineering compliance programs, and driving the completion of all associated documentation.

Key Duties and Responsibilities

Your duties as the Compliance Engineer will be varied however the key duties and responsibilities are as follows:

1. The critical review and approval of maintenance documentation for critical manufacturing equipment. In order to achieve this you will perform regular reviews of the performance of the critical equipment and critical utilities (i.e. HVAC, Compressed Air, medical gases etc), reporting any adverse anomalies. Review and generate CAPA (Corrective Action, Preventative Action) facility improvement plans. Drive the close out of Engineering change controls and facility generated deviations.

2. 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).

3. 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.

4. 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 the engineering SME (Subject Matter Expert) during Regulatory Audits (FDA, MHRA).

Role Requirements

To be successful in your application to this exciting opportunity as the Compliance Engineer we are looking to identify the following on your profile and past history:

1. You will be degree qualified or hold a suitable qualification, such as a HND or HNC, in an engineering discipline.

2. Proven industry experience in a highly regulated cGMP manufacturing environment, such as the Pharmaceutical or Biotechnology sector. This role will be ideal for a multi-skilled engineer with a strong background in compliance.

3. A working knowledge and practical experience in engineering compliance and quality. Excellent communication and documentation skills are key requirement, with a proven ability to communicate and build relationships cross-functionally.


Key Words: Engineering | Compliance | Quality | Pharmaceutical | Production | Manufacturing | cGMP | Maintenance | Utilities | Equipment


Hyper Recruitment Solutions Ltd (HRS) is an Equal Opportunities employer who are certified by Investors in People for talent development. We therefore welcome applications for any interested parties who fulfil the role requirements for this position. HRS is a company exclusively supporting the science and technology sectors, and is made up of a collaboration of recruitment professionals and scientists. We look forward to helping you with your next career moves.
Ben Hamlin
Your Recruitment ConsultantBen Hamlinben.hamlin@hyperec.com
Disclaimer Hyper Recruitment Solutions Ltd (HRS) is an Equal Opportunities employer who are certified by Investors in People for our talent development. We welcome applications for any applicant who fulfil the role requirements for this position. HRS is a company exclusively supporting the science and technology sectors, and is made up of a collaboration of recruitment processionals and scientists. We look forward to helping you with your next career moves.