Job Description

Biocomposites is an international medical devices company that engineers, manufactures, and markets world leading products for use in infection management in bone and soft tissue. Based in Keele, UK, it has global operations across Europe, USA, Argentina, Canada, China, and India. Biocomposites is a world leader in the development of innovative calcium compounds and bone cements for surgical use. Its products regenerate bone and target infection risks across a variety of specialties, including musculoskeletal infection, orthopaedics, trauma, spine, foot and ankle, podiatry, and sports injuries. Biocomposites products are now used in over one million procedures per annum and sold in more than 100 countries around the world.

Job Summary

To safely manufacture, process, inspect and package medical products within a controlled cleanroom environment. The Process Operator will carry out chemical processing, material preparation, equipment operation and product assembly activities while ensuring compliance with GMP, Quality Management System (QMS) requirements, environmental controls and medical device regulations.

This role is critical in delivering safe, effective and high-quality medical products that meet customer and regulatory requirements.

Reports to: Production Supervisor

Location & Working Pattern:
Keele Production Facility, Monday to Friday, 08:00-16:00, with occasional flexibility required to support business needs outside of these hours.

Key Responsibilities

Production Operations

• Carry out manufacturing activities in accordance with approved SOPs, batch records and work instructions.
• Prepare, weigh, mix, blend, filter and process raw materials and chemicals to approved specifications.
• Operate cleanroom manufacturing equipment including mixers, stirrers, filtration systems, autoclaves, ovens and filling equipment.
• Assemble, inspect, fill, label and package medical products within designated cleanroom classifications.
• Complete production activities in line with schedules and departmental targets.
• Perform product changeovers and line clearances in accordance with validation requirements.

Chemical Processing

• Safely handle chemicals, powders, solvents, reagents and raw materials.
• Monitor critical process parameters including temperature, mixing times, weights and environmental conditions.
• Prepare process solutions and blends to specified formulations.
• Perform chemical dispensing and transfer activities using approved containment and handling methods.
• Ensure chemicals are stored, labelled and disposed of in accordance with company procedures and COSHH requirements.

Quality & Compliance

• Complete manufacturing documentation accurately and contemporaneously.
• Perform in-process quality inspections and checks.
• Identify and report process deviations, non-conformances and quality concerns.
• Maintain full product traceability through batch records and production documentation.
• Participate in audits, inspections and continuous improvement activities.
• Follow GMP, ISO 13485 and QMS requirements.

Cleanroom, Equipment & Safety

• Adhere to gowning procedures and cleanroom behavioural standards.
• Maintain housekeeping standards and support contamination control initiatives.
• Perform routine equipment checks, cleaning, sanitisation and basic preventative maintenance.
• Raise maintenance requests for equipment faults and breakdowns.
• Comply with Health & Safety policies, risk assessments, COSHH assessments and safe systems of work.
• Use PPE correctly and report hazards, accidents, near misses and unsafe conditions.

Person Specification

Qualifications & Training

• Technical or science-based qualification, Level 4 or above (e.g. NVQ, HNC or higher).

Experience

• Experience working within a manufacturing or production environment.

Skills & Knowledge

• Good numerical and literacy skills.
• Ability to follow detailed written instructions and procedures.
• Basic computer skills.

Aptitudes & Attributes

• Strong attention to detail and accuracy.
• Good communication and teamwork skills.
• Ability to work in a highly regulated environment.
• Quality focused, safety conscious, organised and dependable.
• Positive attitude towards continuous improvement.
• Flexible and adaptable to changing production priorities.

Desirable

• Experience within medical device, pharmaceutical, biotechnology, healthcare, chemical or laboratory manufacturing.
• Previous cleanroom experience.
• Understanding of GMP.
• Experience handling chemicals and operating processing equipment.

Who do we look for?

People who are passionate about what we do.

People who are open minded to evolving the way we work.

People who can work together to transform outcomes and change lives.

Benefits:

• Company events
• Company pension
• Employee discount
• Free or subsidised travel
• Free On-site parking