Director, Microbial Excellence & Contamination Control

RXinsider LTD.; Greenville (NC); On-site; USD 146,000 - 218,000; Full time

Benefits offered by this job

Health plans

Vision plan

Commuter benefits

Tuition reimbursement

120 hours PTO and holidays

401(k) plan

ESPP

Job summary

Thermo Fisher Scientific in North Carolina is seeking a Director of Quality (Contamination Control and Microbial Excellence) to lead global contamination control and sterility assurance across PSG sites. The role collaborates with Operations, MSAT, Engineering and quality peers to define and implement policies ensuring compliance with current regulatory requirements.

The role requires expertise in microbiology, environmental monitoring, aseptic processing, and GMP/Annex 1 standards, with

Qualifications

• Bachelor’s or advanced degree in Microbiology, Pharmaceutical Sciences, Biotech, or a related field.
• 5–10 years experience in supporting sterile/low bioburden pharmaceutical manufacturing and/or microbiology roles.
• Strong understanding of aseptic manufacturing, cleanroom classification, disinfection, and contamination control.
• Deep knowledge of GMP, Annex 1 (2022 revision), FDA aseptic guidance.
• Prior experience with regulatory inspections and audit defense.

Responsibilities

• Support site based CCME colleagues to develop, implement, and maintain site contamination control strategies based on contamination control risk assessment in alignment with global quality procedures and EU GMP Annex 1, FDA 21 CFR, ISO and PIC/S.
• Provide subject matter expertise in microbiology, microbiological methods, contamination control, aseptic processing, Environmental Monitoring, cleanroom design, cleaning and disinfection and other relevant areas required by site CCME teams and corporate quality management.
• Support global review of EM trends from the PSG network and work with site teams to remediate adverse trends and maintain environmental control in all cleanrooms.
• Provide above-site support and direction to PSG sites for complex deviation or laboratory investigations related to Microbiology, Contamination Control and Sterility Assurance. Where appropriate, support with CAPA plan definition, preventive measures and continuous improvement initiatives.
• Provide above-site support and direction to PSG sites for complex risk assessments related to Microbiology, Contamination Control and Sterility Assurance.
• Provide guidance during facility and process design, including design led contamination controls and material/personnel and waste flows. Provide SME input into the qualification of manufacturing equipment and cleanroom that impact CCME including proper selection and validation of sterilization processes (e.g., autoclaves, SIP, filter integrity testing).
• Inspection Readiness
• Support digitalization and innovation across PSG sites

Skills

Cross-functional collaboration

Regulatory inspections

Effective communication

GMP knowledge

Education

Bachelor’s degree in Microbiology

Tools

RABS

Isolators

Job description

Thermo Fisher Scientific in North Carolina is seeking a Director of Quality (Contamination Control and Microbial Excellence) to lead global contamination control and sterility assurance across PSG sites. The role collaborates with Operations, MSAT, Engineering and quality peers to define and implement policies ensuring compliance with current regulatory requirements.

The role requires expertise in microbiology, environmental monitoring, aseptic processing, and GMP/Annex 1 standards, with