Senior Environmental Monitoring Specialist - Aseptic Processing

Title: Senior Environmental Monitoring Specialist - QC, Aseptic Processing

Location: Greater Boston Area, MA (Hybrid 5 days onsite)

Employment Type: Contract

Status: Accepting Candidates

About the role

Join a Quality Control Microbiology team supporting critical Environmental Monitoring (EM) and Utilities Monitoring (UM) activities in a regulated manufacturing environment. This role serves as a technical SME supporting microbiological testing, contamination control, investigations, and compliance-driven quality operations.

Key Responsibilities

• Provide technical support for Environmental Monitoring (EM) and Utilities Monitoring (UM) activities within QC Microbiology.
• Perform/support microbiological testing including Bioburden, Endotoxin, Sterility, Gram Stain, and Microbial Identification.
• Operate microbiology instrumentation including Vitek, Endosafe, BacT, MALDI-TOF, and Isolator.
• Lead/support OOS/OOT investigations, deviation management, and CAPA implementation related to microbiological methods.
• Prepare EM/UM trend reports, technical documentation, and support laboratory inspections/audits.
• Partner with cross-functional teams supporting manufacturing quality and compliance initiatives.

Qualifications

• 7 years of Microbiology experience in Biotechnology and/or Cell & Gene Therapy environments.
• Hands-on experience in Aseptic Processing, Contamination Control, and GMP manufacturing environments.
• Strong knowledge of Environmental Monitoring, Utilities Monitoring, Sterility, Endotoxin, Bioburden, and microbiological testing methodologies.
• Experience with LIMS, Veeva, and electronic quality management systems.
• Bachelor’s degree in Microbiology or related field.

Compensation (MA Pay Transparency):

• Estimated hourly range: $60–$65/hr (W-2).
• Final rate within this range will be based on skills, experience, and interview results.