Validations Engineer

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.

The Validation Engineer role will primarily be accountable for the validation for processes, facilities, equipment, computer software validations (CSV), in both medical device and pharmaceutical (cGMP) environments, including the Site Validation Master Plan (SVMP).

Duties & responsibilities:

• Maintain Site Validation Master Plans (SVMP), Summary Reports and other required documentation for a validation exercise. Organise and lead validation activities to provide an effective validation service.
• Plan validation activities to ensure customer and business needs are met in alignment with the overall project plans, objectives and schedules.
• Provide validation support and advice to operations and other areas of the business as required to ensure that all operations are carried out in compliance with regulatory and company requirements.
• Ensure design projects relating to processes, facilities, equipment, and CSV validation are in compliance with regulatory and company requirements.
• Provide specialist knowledge on validation of; process, facility, equipment and application of computer software used within production and service.
• Promote effective working relationships and ensure they are maintained through the validation working party. Support a continuous improvement culture within the business.
• Develop work plans, assign tasks, and supervise teams to achieve the overall site validation requirements.

Role Requirements:

• Level 6 within a science regulated industry or relevant experience.
• Minimum 3 years Validation experience within Pharmaceutica/Medical Devices, including cleaning, analytical methods, lab equipment, computer system validation and re-qualification.
• Experience of creation of validation protocols and reports.
• Manufacturing process validation experience preferable, including the validation of new processes and changes to established processes using the lifecycle approach to validation.
• Proficient in Minitab or other alternative system and software packages
• Knowledge of Quality Management Systems.
• Excellent communication skills
• Ability to work to tight deadlines and high 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.

Benefits:

• Company events
• Company pension, life assurance, employee assistance programme
• Employee discount
• Free or subsidised travel
• Free on-site parking