Laboratory Supervisor, MQSA

Job 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 jnj.com. 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. Job Function: Quality Job Sub Function: R&D/Scientific Quality Job Category: People Leader All Job Posting Locations: Warsaw, Indiana, United States of America Job Description: Depuy Synthes a member of the Johnson & Johnson Family of Companies is currently recruiting for a Laboratory Supervisor, Microbiology Quality & Sterility Assurance! This position will be located in Warsaw, IN. Position Summary The Laboratory Supervisor, Microbiology & Analytical Sciences is responsible for the leadership, technical oversight, compliance, and continuous improvement of an ISO 13485-compliant microbiology and chemistry laboratory supporting medical device development, manufacturing, and validation activities. The role oversees laboratory personnel, testing operations, equipment qualification and maintenance, data integrity, method execution, and regulatory compliance. The laboratory supports environmental monitoring, microbiological testing, cleaning validations, sterilization validations, water quality assessments, and microbial identification programs. The Laboratory Supervisor serves as a subject matter expert in microbiology, contamination control, reusable device reprocessing validation, and laboratory quality systems while ensuring compliance with applicable regulatory standards and industry guidance. Key Responsibilities Laboratory Operations & Personnel Management Lead, supervise, train, and develop microbiology and analytical laboratory personnel. Establish performance objectives and ensure execution of laboratory goals, timelines, and quality requirements. Manage laboratory workload, scheduling, resource allocation, and staffing plans. Foster a culture of quality, compliance, safety, scientific rigor, and continuous improvement. Support internal and external audits and regulatory inspections. Microbiology Laboratory Oversight Direct and oversee execution of: Environmental monitoring programsViable air monitoring Non-viable particulate monitoring Surface monitoring Personnel monitoring Compressed gas monitoring Product microbiological testingBioburden testing Sterility testing Microbial limits testing Water and utility testingMicrobial water testing Endotoxin testing Total Organic Carbon (TOC) testing Compressed air quality testing Microbial characterizationMALDI-TOF microbial identification Gram staining Culture characterization Investigation support Microbiological support activitiesMedia preparation Media qualification Growth promotion testing Culture maintenance and preservation Validation & Technical Leadership Provide technical leadership for: Reusable medical device cleaning validation studies Cleaning efficacy assessments Disinfection validation studies Steam sterilization validation and requalification Microbiological method validation and verification Environmental monitoring program design and risk assessments Cleanroom qualification and contamination control strategy development Investigation of microbiological excursions, out-of-specification results, and adverse trends CAPA development and effectiveness verification Equipment Qualification & Lifecycle Management Manage qualification, maintenance, calibration, and lifecycle activities for laboratory equipment including: MALDI-TOF systems Particle counters Air sampling equipment TOC analyzers Endotoxin testing systems Incubators Autoclaves Biosafety cabinets Refrigerators and freezers Laboratory water systems Environmental monitoring equipment Analytical instrumentation supporting microbiological testing Responsible for: Installation Qualification (IQ) Operational Qualification (OQ) Performance Qualification (PQ) Requalification activities Preventive maintenance programs Calibration programs Equipment change control Quality Systems & Compliance Ensure laboratory activities comply with ISO 13485 requirements. Develop, review, and approve SOPs, protocols, reports, work instructions, and technical documentation. Maintain data integrity and documentation practices in accordance with GMP expectations. Support supplier qualification activities and laboratory audits. Manage laboratory investigations, deviations, nonconformances, and CAPAs. Drive continuous improvement initiatives focused on laboratory excellence and operational efficiency. Required Qualifications Education Bachelor's degree in Microbiology, Biology, Biochemistry, Chemistry, Biomedical Sciences, or related scientific discipline. Master's degree preferred. Experience Minimum 8 years of microbiology laboratory experience in the medical device, pharmaceutical, biotechnology, or regulated healthcare industry. Minimum 3 years of supervisory or laboratory management experience. Demonstrated experience managing an ISO 13485-compliant laboratory. Experience supporting FDA, Notified Body, customer, and internal audits. Technical Expertise Demonstrated expertise in: Environmental monitoring programs Bioburden testing Sterility testing Endotoxin testing Microbial water testing TOC testing Compressed air monitoring Microbial identification using MALDI-TOF technology Gram stain techniques Media preparation and qualification Cleaning validation Disinfection validation Steam sterilization validation Laboratory investigations and CAPA management Contamination control programs Risk assessment methodologies Equipment Qualification Experience Hands-on experience performing and approving: IQ/OQ/PQ protocols Equipment validation reports Method validations Requalification programs Calibration and maintenance programs Regulatory & Standards Knowledge Strong working knowledge of: ISO 13485 – Medical Devices Quality Management Systems ISO 14644 – Cleanrooms and Associated Controlled Environments ISO 11137 – Radiation Sterilization of Health Care Products ISO 17664 – Processing of Health Care Products/Reprocessing Instructions AAMI ST98 – Cleaning Validation of Health Care Products Applicable ASTM standards related to medical device cleaning validation and reusable device processing USP microbiological methodologies FDA Quality System Regulation and medical device guidance documents GMP principles and laboratory controls Preferred Qualifications Experience supporting new product development programs. Experience designing and qualifying cleanrooms, water systems, and compressed gas systems. Experience with Laboratory Information Management Systems (LIMS). Certified ISO 13485 Lead Auditor or Internal Auditor. Participation in AAMI, ASTM, PDA, or industry working groups. Experience supporting global manufacturing operations. Key Competencies Laboratory Leadership Technical Decision Making People Development Problem Solving & Root Cause Analysis Cross-Functional Collaboration Regulatory Compliance Risk Management Scientific Writing Project Management Continuous Improvement Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are p