Sr. Cleaning Validation Engineer

Veranova L P • Devens, MA

8d

About The Position

This role is the site SME responsible for coordinating all cleaning validation and verification activities related to intermediate and API manufacturing, including facility surfaces and equipment. This role involves close collaboration with various departments to ensure compliance with regulatory and customer requirements while implementing effective cleaning strategies across the site. The position is integral to maintaining quality and safety standards in the manufacturing process, supporting both current operations and customer needs.

Requirements

• Minimum 7 years of quality assurance experience with an undergraduate degree in engineering, science or related field
• Minimum of 3 years of experience in contamination control and cleaning validation, preferably in a pharmaceutical or biotech manufacturing environment (API CDMO experience is highly desirable)
• Proven leadership experience in pharmaceutical, API/intermediate, drug product, biologics or related FDA industry
• Strong knowledge of cGMP, FDA, EMA, ICH guidelines, and other regulatory standards related to contamination control and cleaning validation with extended knowledge of microbial controls within a comprehensive cleaning program.
• Proficiency with risk assessment tools such as FMEA.
• Previous experience working in cross-functional and project-based environments.
• Experience creating metrics for driving continuous improvement
• Excellent analytical, written and verbal communication and presentation skills
• Hands-on experience with cleaning validation and bioburden reduction strategies
• Driven and detail-oriented, with a strong understanding of cGMP regulations and previous experience in cleaning validation
• Experience driving complex projects with the ability to initiate, prioritize, and successfully complete tasks
• Proven experience working effectively in team situations and as an individual contributor
• Demonstrated behaviours that model the Veranova culture to achieve an inclusive environment and exceptional business results
• A mindset that promotes a positive work culture
• Excellent communication and interpersonal skills with the ability to lead, manage and develop cross-functional relationships
• Analytical mindset with a strong attention to detail and problem-solving skills
• Demonstrated excellent verbal and written communication skills
• Demonstrated networking and influencing skills; ability to collaborate and influence effectively across a broad range of associates spanning varied disciplines and responsibilities
• The ideal candidate will have hands-on experience with cleaning validation processes, strong technical writing skills, and the ability to execute validation protocols independently
• Experience in a fast-paced work environment
• Knowledge of risk-based approaches to cleaning validation (e.g., Risk Assessment and ICH Q9)
• Familiarity with purified water system design and validation

Nice To Haves

• Certification in contamination control is highly desirable.
• Experience with continuous improvement methodologies such as Lean or Six Sigma desired

Responsibilities

• Lead the development, execution, and validation of cleaning procedures for equipment, production lines, and facilities.
• Write and review cleaning validation protocols and reports in compliance with regulatory requirements, ensuring that all materials are free of any residues or contaminants.
• Coordinate and conduct sampling (e.g., swab, rinse, and surface) and analytical testing to validate cleaning processes and confirm cleaning effectiveness.
• Develop and maintain cleaning validation schedules to ensure timely completion of required validations
• Review cleaning validation data, ensuring it meets established acceptance criteria, and make recommendations for process improvements.
• Will mentor and train other staff
• Lead by example in the quality organization
• Develop collaborative working relationships with all other departments and external customers
• Actively participate in daily cross-functional meetings, identifying risks to plan and develop recovery plans.
• Deliver on time results by prescribed due dates
• Demonstrates technical proficiency and self-assuredness in applying cGMP standards to all work
• Applies cGMP concepts in association with department specific responsibilities
• Ensures all documentation produced complies with in compliance with cGMP standards and all state and federal regulations, including but not limited to GMP, DEA, FDA, etc.
• Responsible for developing, maintaining and updating internal policies and procedures

Benefits

• 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.

What This Job Offers

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