Posted:
Sunday, 01 June 2025
Valid Thru:
Tuesday, 01 July 2025
Index Requested on:
06/01/2025 13:12:06
Indexed on:
06/01/2025 13:12:06
Location: Blackpool, LAN, , GB
Industry:
Advertising and Public Relations
Occupational Category:
19-1022.00 - Life, Physical and Social Science
Type of Employment: FULL_TIME
Johnson and Johnson is hiring!
Description:
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:
QualityJob Sub Function:
R& D/Scientific QualityJob Category:
People LeaderAll Job Posting Locations:
Blackpool, Lancashire, United KingdomJob Description:
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/
J& J MedTech is recruiting for a Microbiological Quality & Sterility Assurance Manager reporting to the Sr Mgr Microbiological Quality & Sterility Assurance and to be based in Blackpool (UK).
Description
The Microbiological Quality & Sterility Assurance Manager position is responsible for end-to-end implementation of contamination control and sterility assurance policies and strategies for the DePuy Synthes Blackpool manufacturing site and will assure that Business Unit/Franchise Global Orthopedics programs are aligned with the overall J& J Sterility Assurance programs.
The Microbiological Quality & Sterility Assurance Manager will serve as the Blackpool DePuy Synthes technical leader in the areas of aseptic processing, contamination control, sterilization, reprocessing and microbiology. They manage teams to support product development and product manufacturing activities. They set the strategic and tactical direction of the team through the application of technical knowledge and expertise in contamination control, aseptic processing, sterilization processing and industrial microbiology. This position is responsible for compliance to applicable Quality Regulations and standards.
This individual will be responsible for activities such as, but not limited to, the following:
The technical areas overseen by the Microbiological Quality & Sterility Assurance Manager include: aseptic processing, cleaning and disinfection requirements, sterilization validation (for EO, gamma, electron beam, x-ray, moist heat, and dry heat processes), reprocessing, microbiological testing to support the validation and maintenance of the sterilization processes and product label claims (e.g., bioburden, tests of sterility, endotoxin monitoring), environmental control and monitoring, water and air systems validation, sterility assurance support to new product development and launch, compliance to applicable regulations and standards in the subject areas of sterility assurance and laboratories. Inspection and submission support and Health based risk assessment.
The Microbiological Quality & Sterility Assurance Manager will also be responsible to ensure the development of their team to include career development, work-life balance, succession planning etc.
qualified candidates will have experience in microbiology, sterilization validation (terminal, aseptic, and/or reprocessing) and environmental controls for a medical device or pharmaceutical manufacturing facility demonstrated capability to lead and train a large and diverse, multinational community with multiple stakeholders, working in a supervisory, coaching, mentoring and/or influencing capacity must have a strong understanding of product design, quality and manufacturing processes. proven track record on troubleshooting process non-conformances and out of specification test results, and providing resolution to issues by a robust CAPA process experience in interacting with Regulatory Authorities is preferred experience with conducting technical assessments of in-house and external manufacturing and terminal sterilization is preferred strong knowledge of standards including EU, USA and ISO is required strong teamwork and communication skills to work effectively on cross-functional project teams, interacting with a diversity of disciplines such as R & D, Packaging Engineering, Quality Engineering, Regulatory Affairs, Marketing, etc. independent organizational and time management skills is required
Responsibilities:
Please review the job description.
Educational requirements:
Desired Skills:
Please see the job description for required or recommended skills.
Benefits:
Please see the job description for benefits.