Compliance Engineer

bioM?rieux BV; Cramlington; On-site; GBP 40,000 - 55,000; Full time

Job summary

A global healthcare company is seeking a Compliance Engineer for its Cramlington site. The role involves managing engineering compliance across a GMP-regulated environment, ensuring adherence to statutory regulations, and preparing for audits. Ideal candidates will have a degree in Engineering and relevant experience. This position offers the opportunity to enhance compliance systems and collaborate with diverse teams within the organization.

Qualifications

• Degree in Engineering or a related technical discipline, or equivalent experience.
• Experience working in a GMP-regulated manufacturing environment is highly desirable.
• Proven ability to manage compliance systems and documentation effectively.
• Strong understanding of statutory engineering regulations.

Responsibilities

• Maintain and continuously improve engineering compliance programs across the site.
• Ensure adherence to statutory regulations including LOLER, PSSR, PUWER.
• Act as a subject matter expert during internal and external audits.
• Collaborate with internal stakeholders to define ownership and ensure timely completion of compliance actions.

Skills

Statutory engineering regulations understanding

Audit preparation and representation

Collaboration skills

Detail-oriented approach

Education

Degree in Engineering or related technical discipline

Job description

Job Description

Organon is hiring a Compliance Engineer to join us at our world‑class manufacturing site in Cramlington, Northumberland.

As a Compliance Engineer, you will play a pivotal role in supporting our Facilities Management (FM) team to uphold and continuously enhance engineering compliance across our GMP manufacturing site. This role offers a unique opportunity to provide technical oversight of statutory engineering requirements while managing compliance governance systems and documentation. You’ll act as a key contact during audits, ensuring the site is always audit‑ready and that engineering compliance is clearly and confidently represented. Working closely with internal stakeholders, you’ll help define ownership of compliance actions, monitor performance against regulatory standards, and drive continuous improvement. Reporting directly into the FM organisation and collaborating closely with Safety, Health, and Environmental teams, you’ll ensure our engineering systems remain safe, efficient, and fully compliant.

Role Responsibilities

• Maintain and continuously improve engineering compliance programs across the site.
• Ensure adherence to statutory regulations including LOLER, PSSR, PUWER, and other relevant standards.
• Lead the management of compliance governance systems and documentation.
• Act as a subject matter expert during internal and external audits.
• Prepare and present compliance data and evidence to auditors and regulatory bodies.
• Collaborate with internal stakeholders to define ownership and ensure timely completion of compliance actions.
• Liaise with Safety & Environmental teams to align compliance efforts.
• Support and monitor IFM and Maintenance teams in delivering compliance objectives.

Education, Experience and Skills

• Degree in Engineering or a related technical discipline, or equivalent experience.
• Strong understanding of statutory engineering regulations (e.g., LOLER, PSSR, PUWER).
• Experience working in a GMP‑regulated manufacturing environment is highly desirable.
• Proven ability to manage compliance systems and documentation effectively.
• Confident in audit preparation and representation, with excellent communication skills.
• Strong collaboration skills with the ability to influence across departments.
• Detail‑oriented with a proactive approach to identifying and resolving compliance gaps.
• Familiarity with compliance performance metrics and continuous improvement tools.

Who We Are

Organon delivers ingenious health solutions that enable people to live their best lives. We are a $6.5 billion global healthcare company focused on making a world of difference for women, their families and the communities they care for. We have an important portfolio and are growing it by investing in the unmet needs of Women’s Health, expanding access to leading biosimilars and touching lives with a diverse and trusted portfolio of health solutions. Our Vision is clear: A better and healthier every day for every woman.

Equal Opportunity Statement

As an equal opportunity employer, we welcome applications from candidates with a diverse background. We are committed to creating an inclusive environment for all our applicants.