We are seeking an experienced Maintenance Engineer to support the maintenance and reliability of production equipment within a pharmaceutical manufacturing facility. The successful candidate will play a key role in ensuring equipment uptime, regulatory compliance, and continuous improvement of manufacturing operations in a GMP-regulated environment.
Key Responsibilities
- Perform planned preventative maintenance (PPM) and reactive maintenance on pharmaceutical manufacturing and packaging equipment.
- Troubleshoot and resolve mechanical, electrical, pneumatic, and hydraulic failures to minimise downtime.
- Support manufacturing operations by ensuring equipment reliability, availability, and performance.
- Execute maintenance activities in compliance with GMP, health and safety, and company quality standards.
- Maintain accurate maintenance documentation, work orders, calibration records, and asset histories using a CMMS.
- Assist with equipment qualification, validation, and commissioning activities for new installations and process improvements.
- Support root cause investigations, deviation management, and implementation of corrective and preventive actions (CAPA).
- Collaborate with Production, Engineering, Quality Assurance, and Validation teams to ensure efficient plant operation.
- Participate in continuous improvement initiatives focused on equipment reliability, OEE, and manufacturing efficiency.
- Support contractor management and ensure all maintenance activities are performed safely and in accordance with site procedures.
Requirements
- HNC/HND, Apprenticeship, or Degree in Mechanical Engineering, Electrical Engineering, Mechatronics, or related discipline.
- Previous maintenance engineering experience within a pharmaceutical, biotechnology, medical device, or other highly regulated manufacturing environment.
- Strong understanding of GMP regulations and pharmaceutical manufacturing processes.
- Experience maintaining production, packaging, utility, or process equipment.
- Ability to diagnose and repair electrical and mechanical faults.
- Familiarity with CMMS systems and maintenance documentation practices.
- Knowledge of calibration, validation, and qualification requirements within regulated industries is desirable.
- Strong problem-solving skills with a proactive approach to continuous improvement.
- Excellent communication and cross-functional collaboration abilities.
Preferred Experience
- Experience supporting sterile, aseptic, solid dose, biologics, or packaging operations.
- Knowledge of PLC-controlled equipment and automated manufacturing systems.
- Exposure to Lean Manufacturing, TPM, or Reliability-Centred Maintenance methodologies.
- Understanding of GMP investigations, deviations, CAPA, and change control processes.
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Maintenance Engineer employer: BioTalent
Join a dynamic and innovative biosimilars organisation in London, where your expertise as a Manager of Analytical Development will be valued and impactful. We foster a collaborative work culture that prioritises employee growth through continuous learning and development opportunities, ensuring you can advance your career while contributing to cutting-edge scientific advancements. With a focus on biosimilarity assessment and analytical strategy, you'll play a crucial role in shaping our scientific capabilities in a supportive environment that champions teamwork and excellence.
