Microbiological Quality & Sterility Assurance Manager

Johnson and Johnson; Blackpool; On-site; GBP 50,000 - 75,000; Full time

Job summary

A leading company in healthcare innovation seeks a Microbiological Quality & Sterility Assurance Manager in Blackpool. This role involves ensuring compliance with regulations, leading teams in contamination control, and supporting product development. Candidates should possess strong microbiology and management skills, with at least 8 years of experience in a regulated environment.

Benefits

Comprehensive range of benefits

Qualifications

• At least 8 years of relevant experience.
• Proven management skills.
• Proficiency in computer software.

Responsibilities

• Provide technical leadership in contamination control.
• Support new product development and manufacturing.
• Ensure compliance with regulations and standards.

Skills

Microbiology

Sterilization validation

Environmental controls

Team leadership

GMP regulations

ISO standards

Technical leadership

Education

BS in Microbiology, Biology, Engineering, or related

Job description

Microbiological Quality & Sterility Assurance Manager

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through 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 humanity. Learn more at https://www.jnj.com

Job Function: Quality

Job Sub Function: R&D/Scientific Quality

Job Category: People Leader

All Job Posting Locations: Blackpool, Lancashire, United Kingdom

Job Description:

J&J MedTech is recruiting for a Microbiological Quality & Sterility Assurance Manager reporting to the Sr Mgr Microbiological Quality & Sterility Assurance based in Blackpool (UK).

The role involves implementing contamination control and sterility assurance policies for the DePuy Synthes Blackpool site, serving as the technical leader in aseptic processing, contamination control, sterilization, reprocessing, and microbiology. Key responsibilities include supporting product development and manufacturing activities, ensuring compliance with regulations, and leading teams in contamination control and sterilization strategies.

Responsibilities include:

• Providing technical leadership in contamination control and sterility assurance for new product development.
• Supporting support during product development cycles.
• Applying best practices in sterilization methodologies.
• Ensuring design changes meet sterility requirements.
• Supporting due diligence for acquisitions and licensing.
• Developing design history files and regulatory submissions.
• Driving innovation in sterilization methods.

Additional duties encompass planning manufacturing operations, supporting business acquisitions, participating in due diligence, supporting procurement, providing technical input on manufacturing process design, maintaining knowledge of standards, managing microbiological CAPAs, supporting external audits, and engaging with external industry standards and regulators.

The ideal candidate will have experience in microbiology, sterilization validation, environmental controls, and team leadership within a GMP or ISO regulated environment, with strong knowledge of standards like EU, USA, and ISO. Education requirements include a BS in Microbiology, Biology, Engineering, or related, with at least 8 years of relevant experience, proven management skills, and proficiency in computer software.

We prioritize your well-being with a comprehensive range of benefits designed to support you both personally and professionally.