Scientist Microbiologist, Orthopaedics

At Johnson & Johnsonwe believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented treated and curedwhere treatments are smarter and less invasive andsolutions are our expertise in Innovative Medicine and MedTech we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow and profoundly impact health for more at .

As guided by Our Credo Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson we respect the diversity and dignity of our employees and recognize their merit.

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About Orthopaedics

Fueled by innovation at the intersection of biology and technology were 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 thats 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. Learn more at are searching for the best talent to join our DePuy Synthes business as a Scientist Microbiologist in Blackpool UK.

Purpose:

You will be responsible for supporting endtoend 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 nonconformances 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:

• Bachelors 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 nonconformances 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 timemanagement and flexibility skills.
• Proficiency in Microsoft Office applications (Word Excel PowerPoint) and analytical software.

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 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.

At Johnson & Johnson we want every candidate to feel supported throughout the hiring process. Our goal is to make the experience clear fair and respectful of your time.

Heres what you can expect:
Application review: Well carefully review your CV to see how your skills and experience align with the role.
Getting to know you: If theres a good match youll be invited to a short call with one of our recruitment team to understand more about you and answer any questions that you might have.
Staying informed: We know waiting can be hard and processes can evolve; our recruitment team will keep you updated and make sure you know what to expect at each step.
Final steps: For successful candidates you will need to complete countryspecific checks before starting your new role. We will help guide you through these.

Finally at the end of the process well invite you to share feedback in a short survey your input helps us continue improving the experience for future candidates.

Thank you for considering a career with Johnson & Johnson. Were excited to learn more about you and wish you the best of luck in the process!

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