Microbial Contamination Control Specialist

Veranova L P • Devens, MA

6h • Onsite

About The Position

The Microbial Contamination Control Specialist serves as the site SME for microbial contamination control, cleaning validation, and environmental monitoring supporting ADC and bioconjugate API manufacturing. This role is critical for managing microbial risks in bioconjugation operations, ensuring that single-use systems, equipment, and controlled environments meet cGMP, regulatory, and customer requirements. The position develops and executes contamination-control strategies to protect product quality across clinical and commercial operations. Through collaboration with Manufacturing, Quality, Engineering, and Analytical teams, this role strengthens contamination-control programs that support facility startup, ongoing operations, and multi-campaign manufacturing.

Requirements

• Minimum 10 years of quality assurance experience and 5 years microbiology experience with an undergraduate degree in microbiology, or
• Minimum 7 years of quality assurance experience and 3 years microbiology experience with an undergraduate degree in microbiology.
• Minimum of 3 years of experience in contamination control, cleaning validation, environmental monitoring, and/or purified water systems, preferably in a pharmaceutical or biotech manufacturing environment (API CDMO experience is highly desirable).
• Strong knowledge of cGMP, FDA/EMA/ICH guidance, and microbial control principles for biologics/bioconjugation manufacturing.
• Hands-on experience with environmental monitoring, microbial sampling, microbial identification, bioburden reduction, and cleaning validation.
• Proven experience performing microbial risk assessments, investigations, and implementing CAPAs.
• Proven experience in drafting and executing Environmental Monitoring Performance Qualification (EMPQ).
• Ability to lead cross-functional teams and drive contamination control initiatives across multi-product campaigns.
• Strong technical writing, communication, and analytical skills, with experience authoring protocols, EM trend reports, and validation documents.

Nice To Haves

• Certification or training in contamination control, aseptic/cleaning validation, Lean, or Six Sigma. (preferred)

Responsibilities

• Lead microbial contamination-control strategy for ADC and bioconjugation operations, addressing risks from high-potency payloads, complex linker chemistries, and single-use systems.
• Lead initial area qualification and environmental monitoring program establishment for ADC and bioconjugation suites and critical utility systems.
• Oversee development, execution, and validation of cleaning procedures for equipment, production lines, and facility surfaces to ensure effective bioburden reduction and cross-contamination prevention.
• Manage environmental monitoring programs, including air and surface sampling, data trending, excursion investigation, and CAPA implementation.
• Conduct microbial risk assessments and maintain contamination-prevention SOPs and mitigation plans in alignment with cGMP and regulatory standards.
• Establish and track microbial KPIs to drive continuous improvement in cleaning effectiveness and contamination control.
• Provide technical support during audits and inspections, ensuring complete and compliant documentation for cleaning validation and environmental monitoring activities.
• Train and mentor staff on microbial control best practices and contamination prevention strategies.

Benefits

• Comprehensive health & wellness benefits.
• Access to mental health resources and wellness programs.
• Generous PTO and holiday pay policies.
• Competitive base salary
• Eligibility for performance-based bonuses
• Attractive 401(k) Plan with company match.
• Opportunities for continuous learning through LinkedIn Learning, workshops, conferences, and mentorship.
• Tuition Assistance for Undergraduate and Graduate degree programs.

What This Job Offers

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