Principal Scientist, Microbiological Quality & Sterility Assurance (MedTech)

Location: Limerick, Ireland; onsite work three days per week with travel to other sites, external manufacturers, suppliers, and audit locations. Travel expectation: 50%.

Base pay: €70,100.00–€121,210.00 per year, plus an annual bonus and benefits.

Company

Johnson & Johnson MedTech develops less invasive and personalized healthcare treatments through the intersection of biology and technology.

What you will do

• Lead end-to-end microbiological quality and sterility assurance strategies for the Johnson & Johnson Vision franchise.
• Drive sterilization site and process validation, including cycle development, process characterization, protocol and report approval, and regulatory support.
• Own technical activities covering aseptic processing, terminal sterilization, microbiological testing, environmental monitoring, water systems, cleanrooms, and contamination control.
• Support new product introduction, packaging validation, manufacturing process design, product launches, lifecycle management, and process improvements.
• Investigate microbiological, aseptic processing, utilities, cleanroom, and sterility issues, including non-conformances and out-of-specification results, and support CAPA resolution.
• Represent the organization with regulatory authorities, industry associations, standards groups, universities, and internal MQSA communities.

Requirements

• At least 10 years of experience in the medical device or pharmaceutical industry within a GMP- and/or ISO-regulated environment.
• BS degree in Microbiology, Biology, Engineering, or a related discipline; an MS or PhD is preferred.
• Demonstrated expertise in microbiology, terminal sterilization, aseptic processing, environmental controls, and microbiological quality for medical device manufacturing.
• Experience with multiple sterilization methods, including moist heat, dry heat, VHP, EO, gamma, electron beam, X-ray, and reprocessing.
• Ability to lead, train, coach, mentor, and influence a diverse multinational community of practice and multiple stakeholders.
• Strong knowledge of global external standards, regulatory support, technical investigations, validation, and CAPA.

Nice to have

• Advanced degree in a relevant scientific or engineering discipline.
• Experience interacting with regulatory authorities and assessing internal and external manufacturing and sterilization operations.
• Experience representing a corporation at industry and standards associations.

Culture & Benefits

• Inclusive work environment focused on individual contribution, diversity, and dignity.
• Vacation, parental leave of at least 12 weeks, bereavement, caregiver, and volunteer leave.
• Well-being reimbursement and financial, physical, and mental health programs.
• Insurance plans, service anniversary awards, and recognition programs subject to plan and location terms.
• Collaboration with R&D, manufacturing, regulatory, scientific, and technical communities.

Hiring process

• The position reports directly to the Director of Johnson & Johnson Microbiological Quality & Sterility Assurance.