Job Description

At [Employer hidden — sign up to reveal], we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions. Learn more at [Employer hidden — sign up to reveal].

As guided by Our Credo, [Employer hidden — sign up to reveal] is responsible to our employees. We provide an inclusive work environment where each person is considered as an individual.

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. Our Orthopaedics teams help keep more than 6 million people moving each year. Learn more at [Employer hidden — sign up to reveal].

We are searching for the best talent to join our [Employer hidden — sign up to reveal] business as a Scientist – Microbiologist in Blackpool, UK.

Purpose

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.

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.

Additional Information

[Employer hidden — sign up to reveal] announced plans to separate our Orthopaedics business to establish a standalone orthopaedics company, operating as [Employer hidden — sign up to reveal]. The process is anticipated to be completed within 18 to 24 months. Should you accept this position, it is anticipated that you would be an employee of [Employer hidden — sign up to reveal].

At [Employer hidden — sign up to reveal], we want every candidate to feel supported. Our goal is to make the experience clear, fair, and respectful.