What are the responsibilities and job description for the Environmental Monitoring SME – QC Microbiology position at JMD Technologies Inc.?
Title: Environmental Monitoring SME – QC Microbiology
Location: Portsmouth, NH (Onsite)
Employment Type: Fulltime / Permanent
Status: Accepting Candidates
About the role
Join a quality-focused manufacturing environment as a senior technical leader supporting the Environmental Monitoring program. This role will drive microbial control strategy, lead complex investigations, support regulatory readiness, and mentor QC teams in a cGMP setting.
Key Responsibilities
- Serve as the technical SME for Environmental Monitoring and utility monitoring programs
- Lead complex environmental excursion investigations using root cause analysis (RCA) and drive effective CAPA implementation
- Perform advanced trending and analysis of environmental and utility data to identify contamination risks and long-term trends
- Support internal and external regulatory inspections, including audit defense for EM procedures and data
- Review and approve laboratory records, validation protocols, and technical reports
- Mentor junior analysts and support continuous improvement initiatives across the QC microbiology function
Qualifications
- Bachelor’s degree in Microbiology, Biology, or Life Sciences
- 5–10 years of experience in QC Microbiology or Environmental Monitoring within a cGMP manufacturing environment
- Strong expertise in cleanroom classifications (Grade A–D) and aseptic processing
- Deep understanding of FDA, EMA, ICH, and current global regulatory expectations
- Experience with LIMS, data trending tools, and technical documentation review
- Proven ability to lead cross-functional projects and communicate scientific findings to leadership and auditors