Environmental Monitoring and Utilities Monitoring Technical Support, Quality Control Microbiology (Contract)

Atrium Works • Boston, MA

23h • Onsite

About The Position

The Environmental Monitoring and Utilities Monitoring Technical support role will provide technical support for the EM/UM team as a Subject Matter Expert (SME). This role will serve as a key resource within the organization, providing technical expertise in the areas of EM/UM sampling, testing, aseptic processing, and contamination control in accordance with regulatory standards. This role reports to the Associate Director of Quality Control in Cell and Genetic Therapies (VCGT). This is an on-site role and a 12-month contract with the chance to extend.

Requirements

• Extensive knowledge and experience of Quality Control methods and compendial requirements including but not limited to (Sterility, Endotoxin, Environmental monitoring, ID, APS/PAQ processes)
• Strong understanding of Aseptic processing and contamination control strategies in manufacturing facilities
• Extensive experience working in a GMP environment
• Strong communication and scientific writing
• Strong project management skills
• Bachelor’s degree in Microbiology or related field.
• A minimum of 7 years of industry experience in Microbiology in a Biotechnology and/or Cell and Gene therapy organization.

Nice To Haves

• Experience with electronic systems such as LIMS and Quality Management Systems (Veeva) preferred

Responsibilities

• Demonstrates a strong understanding of sampling and microbiological testing methodologies including but not limited to EM, UM, Bioburden, Endotoxins, Sterility, Gram Stain, and Identification program per relevant regulatory standards
• Hands-on experience in the handling of microbiology lab instruments i.e. Vitek, Endosafe, BacT, MALDI-TOF, Isolator
• Organize, plan, and support team members with technical questions and problem-solving to ensure group efficiency and accountability
• Ensure compliance with current Good Manufacturing Practices (cGMP), as well as Health, Safety, and Environmental policies per Vertex standards
• Provide subject matter expertise in Out-of-Specification (OOS) and Out-of-Trend (OOT) investigations
• Manages deviations and Corrective and Preventative Action (CAPA) implementation associated with Microbiological methodologies
• Support laboratory inspections and audits, including addressing follow-up actions and ensuring continuous improvement
• Collaborate with cross-functional teams, including Manufacturing, Quality Assurance, Regulatory CMC, and Analytical Development, to ensure alignment and effective communication between teams
• Provide guidance in drafting EM/UM Trend Reports
• Assist with document revisions.

Benefits

• Compensation, medical benefits, fringe benefits and other terms and conditions of employment shall be presented by the third-party agency partner upon offer.
• This position will be eligible for overtime pay, in accordance with federal and state requirements.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior