Microbial Contamination Specialist

Discover Veranova

At Veranova, we believe people are our most important asset, and we are dedicated to building the most talented workforce in our industry.

Our commitment to uncompromising focus on quality, compliance, safety, and excellence shapes everything we do. We are not just looking for skills; we are seeking innovative individuals who have a mindset open to learning and growth, and a desire to make a difference.

Veranova is a global leader in the development and manufacturing of complex active pharmaceutical ingredients (APIs) for pharma and biotech customers. We develop solutions and processes that support and accelerate innovation. Join us on our mission to enable current and next-generation therapeutics to improve and save the lives of patients.

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.

• Lead microbial contamination‑control strategy for ADC and bioconjugation operations, addressing risks from high‑potency payloads, complex linker chemistries, and single‑use 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.

• Minimum 7 years of quality assurance experience with an undergraduate degree in engineering, science or related field, or
• Minimum of 5 years of quality assurance experience with a graduate degree in engineering, science, or related field.
• 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.
• 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.

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

$100,000 - $115,000 annual base salary

• Health & Wellness:
  Comprehensive health & wellness benefits, access to mental health resources and wellness programs, generous PTO and holiday pay policies.
• Financial Wellness:
  Competitive base salary, eligibility for performance‑based…