Microbial Contamination Control Specialist at Veranova L P

Devens, Massachusetts, United States -

Full Time

Start Date

Immediate

Expiry Date

02 Jun, 26

Salary

140000.0

Posted On

04 Mar, 26

Experience

10 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Microbial Contamination Control, Cleaning Validation, Environmental Monitoring, cGMP, Risk Assessment, SOP Development, CAPA Implementation, API Manufacturing, Bioconjugation, Single-Use Systems, Microbial Sampling, Bioburden Reduction, EMPQ Execution, Technical Writing, Data Trending, Auditing Support

Industry

Pharmaceutical Manufacturing

Description

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 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. JOB PURPOSE 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. PRINCIPAL ACCOUNTABILITIES * 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. PERSON SPECIFICATION QUALIFICATIONS/ KNOWLEDGE/ EXPERIENCE (Technical/ professional knowledge and skills competency) * 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). PERSONAL SKILLS AND KEY COMPETENCIES * 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. (preferred) Salary Range: $125,000 - $140,000 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 don’t 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 our privacy notice [https://veranova.com/privacy-policy/]. #LI-Onsite

Responsibilities

The specialist will lead the microbial contamination control strategy for ADC and bioconjugation operations, overseeing the establishment and execution of environmental monitoring programs and cleaning validation procedures. This role is critical for managing microbial risks, ensuring compliance with cGMP and regulatory standards across clinical and commercial manufacturing.