Scientist - Microbiologist, Orthopaedics in Burnley

About Orthopaedics: Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments. Are you passionate about improving and expanding the possibilities of Orthopaedics? Ready to join a team that’s reimagining how we heal? Our Orthopaedics teams help keep more than 6 million people moving each year while delivering clinical and economic value to surgeons and healthcare systems. Our teams build solutions for joint reconstruction; trauma and craniomaxillofacial; sports, extremities, and elective foot and ankle; spine; and robotics and digital surgery.

Your unique talents will help patients on their journey to wellness. You will be responsible for supporting end‑to‑end contamination control and sterility assurance practices across Global Orthopedics. This role supports research and development, manufacturing, sourcing, and delivery activities to ensure compliance with applicable international regulations and standards. You will report to a Sterility Assurance Supervisor or Sterility Assurance Manager and collaborate with internal and external partners to support product cleanliness, sterility assurance, and regulatory compliance.

You Will Be Responsible For:

• Supporting R&D activities, including design for cleanability, decontamination, and sterilizability.
• Supporting selection, validation, and adoption of sterilization modalities and processes.
• Establishing and maintaining contamination control, environmental monitoring, and sterility assurance programs.
• Providing sterility assurance input into new manufacturing operations, equipment, facilities, and suppliers.
• Supporting design and validation of manufacturing processes, packaging systems, and controlled environments from a microbiological perspective.
• Supporting MAKE initiatives through risk assessments, bioburden management, and dose audit programs.
• Leading or supporting non‑conformances, CAPAs, and observations related to sterility assurance and contamination control.
• Working with internal and external laboratories to support microbiological and sterility testing in compliance with cGMP and SOP requirements.
• Supporting inspections, audits, regulatory submissions, and design history file documentation.
• Influencing standards and best practices through participation in internal councils and external industry or standards associations.

Qualifications / Requirements:

• Bachelor’s degree in Microbiology, Biology, Engineering, or a related discipline; advanced degree (MS or PhD) preferred.
• Minimum of 1-2 years’ experience in a medical device or pharmaceutical GMP and/or similarly regulated environment.
• Experience in microbiology, sterilization validation (terminal, aseptic, and/or reprocessing), and environmental controls.
• Proven experience troubleshooting microbiological, aseptic processing, or sterilization non‑conformances and CAPA activities.
• Strong knowledge of regulatory requirements including FDA QSR and ISO 13485; familiarity with ISO/EN/AAMI standards preferred.
• Experience interacting with regulatory or auditing bodies (e.g. FDA, EU authorities) preferred.
• Strong interpersonal, organisational, and written and verbal communication skills.
• Ability to work independently while collaborating effectively in a team environment.
• Strong organisational, time‑management, and flexibility skills.
• Proficiency in Microsoft Office applications (Word, Excel, PowerPoint) and analytical software.

Company Changes: Johnson & Johnson announced plans to separate our Orthopaedics business to establish a standalone orthopaedics company, operating as DePuy Synthes. The process of the planned separation is anticipated to be completed within 18 to 24 months, subject to legal requirements, including consultation with works councils and other employee representative bodies, as may be required, regulatory approvals and other customary conditions and approvals. Should you accept this position, it is anticipated that, following conclusion of the transaction, you would be an employee of DePuy Synthes and your employment would be governed by DePuy Synthes employment processes, programs, policies, and benefit plans. In that case, details of any planned changes would be provided to you by DePuy Synthes at an appropriate time and subject to any necessary consultation processes.