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 focuses on quality compliance safety and excellence in delivery 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. With deep technical expertise and impressive flexibility 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.

Role Overview:

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.

Core Responsibilities:

• 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.

Qualifications:

• 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.

Preferred

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

Salary Range: $100000 - $115000 annual base salary

Our Commitment:

• Health & Wellness: Comprehensive health & wellness benefits. Access to mental health resources and wellness programs. Generous PTO and holiday pay policies.
• Financial Wellness: Veranova is committed to fair and transparent compensation practices. This includes a competitive base salary eligibility for performance-based bonuses and an attractive 401(k) Plan with company match. Salary ranges reflect the scope and expectations of the role and are based on market data internal equity and role-specific factors. Final compensation may vary depending on experience skills education and business needs.
• Professional Development: Opportunities for continuous learning through LinkedIn Learning workshops conferences and mentorship. Tuition Assistance for Undergraduate and Graduate degree programs.
• Inclusive Culture: At Veranova an inclusive culture is integral to our values. We welcome people with diverse experiences and perspectives who share our mission to improve and save lives. Even if you dont meet every qualification we encourage you to apply. Veterans first responders and those transitioning from military to civilian life bring valuable skills that strengthen our team.

Additional Information:

Applicants for this role must be authorized to work in the United States without further employer sponsorship.

Agency and Search Firm Representatives: Veranova does not accept unsolicited resumes from agencies and/or search firms for this job posting.

All your information will be kept confidential according to EEO guidelines.

Veranova is an Equal Opportunity Employer. It is the policy of Veranova to provide equal employment access and opportunity to all persons regardless of age race color national origin religion sex sexual orientation gender identity and/or expression physical or mental disability genetic information citizenship marital status veteran status or any other characteristic protected by federal state or local law.

All applications are carefully considered and your details will be stored on our secure Application Management System. This is used throughout Veranova for the selection of suitable candidates for our vacancies as they arise. Veranova respects your privacy and is committed to protecting your personal information. For more information about how your personal data is used please view ourprivacy notice.

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