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, we have global operations across USA, Canada, Europe, China and India.

We are a world leader in the development of innovative calcium compounds for surgical use. Our products target a broad spectrum of infection risks across a variety of specialties, including musculoskeletal infection, orthopaedics, trauma, spine, foot and ankle and podiatry. The STIMULAN® products are the first calcium matrices to receive approval to treat bacterial infection in soft tissue surrounding bone, and European approval for mixing with antibiotics such as vancomycin, gentamicin and tobramycin, for use in bone and soft tissue.

In 2022, Her Majesty the Queen honoured us with two Queen’s Awards for Enterprise in Innovation and International Trade in recognition of the impact of STIMULAN in infection cases and our outstanding continuous growth in overseas sales of more than 200% over six years.

Biocomposites products are now used in over 120,000 procedures every year and sold in more than 40 countries around the world.

The Role

The Validations Engineer will primarily be accountable for the validation for Processes, Facilities, Equipment, Cleaning, Computer Software Validations (CSV) and IT projects, in both a Medical Device and Pharmaceutical (cGMP) environment, including the Site Validation Master Plan (SVMP) and maintenance of such plan.

RESPONSIBILITIES:

• Prepare and issue Site Validation Master Plans (SVMP), Summary Reports, and other required documentation for validation exercises, leading validation activities to ensure an effective validation service.
• Plan and schedule validation activities to meet customer and business needs in alignment with overall project objectives and timelines.
• Provide validation leadership to ensure that operations comply with regulatory and company requirements, offering support and advice to other departments as necessary.
• Oversee validation projects related to processes, facilities, equipment, cleaning, and CSV/IT validation, ensuring full compliance with regulatory and company standards.
• Provide specialist knowledge on validation processes, facilities, equipment, cleaning, and the use of computer software within production and service environments.

REQUIRED EXPERIENCE:

• Level 6 qualification within a regulated science industry or equivalent experience
• Minimum 5 years of validation experience in the Pharmaceutical/Medical Devices sector, including cleaning, analytical methods, lab equipment, computer system validation, and re-qualification
• Proficient in Minitab or similar system/software packages
• Manufacturing process validation experience preferable, including the validation of new processes and changes to established processes using the lifecycle approach to validation
• Knowledge of Quality Management Systems ISO14971
• Excellent communication skills
• Ability to take initiative within controlled working environment
• Ability to meet deadlines
• Attention to detail

What do we offer?

Competitive salary and benefits! With us, you will receive a competitive salary package and benefits.

We grow talent. At Biocomposites we create opportunities to thrive and grow.

One Biocomposites – team spirit & engagement. Our culture is important and we strive to create engaged and inclusive global teams that encourage colleagues to share their diverse perspectives and opinions.

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.

If you are interested please forward your CV to careers@biocomposites.com