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 SummaryThe 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 ResponsibilitiesLaboratory 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 OversightDirect and oversee execution of:
- Environmental monitoring programs
- Viable air monitoring
- Non-viable particulate monitoring
- Surface monitoring
- Personnel monitoring
- Compressed gas monitoring
- Product microbiological testing
- Bioburden testing
- Sterility testing
- Microbial limits testing
- Water and utility testing
- Microbial water testing
- Endotoxin testing
- Total Organic Carbon (TOC) testing
- Compressed air quality testing
- Microbial characterization
- MALDI-TOF microbial identification
- Gram staining
- Culture characterization
- Investigation support
- Microbiological support activities
- Media preparation
- Media qualification
- Growth promotion testing
- Culture maintenance and preservation
Validation & Technical LeadershipProvide 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 ManagementManage 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 QualificationsEducation- 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 ExpertiseDemonstrated 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 ExperienceHands-on experience performing and approving:
- IQ/OQ/PQ protocols
- Equipment validation reports
- Method validations
- Requalification programs
- Calibration and maintenance programs
Regulatory & Standards KnowledgeStrong 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
Required Skills: Preferred Skills: 
