WHO WE ARE:

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.

QUALIFICATIONS:

Required

• 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, cleaning validation, environmental monitoring, and/or purified water systems, preferably in a pharmaceutical or biotech manufacturing environment (API CDMO experience is highly desirable)
• Proven leadership experience in pharmaceutical, API/intermediate, medical device, biologics or related FDA industry
• Strong knowledge of cGMP, FDA, EMA, ICH guidelines, and other regulatory standards related to contamination control, cleaning validation, environmental monitoring, and purified water systems
• Experience with microbiological sampling, environmental monitoring, and testing of purified water systems in a regulated pharmaceutical environment
• 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, TOC analysis, 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
• A mindset that promotes a positive work culture
• The ideal candidate will have hands-on experience with sterile and cleaning validation processes, strong technical writing skills, and the ability to execute validation protocols independently
• Certification in contamination control (e.g., PDA Certification in Contamination Control).
• Knowledge of risk-based approaches to cleaning validation (e.g., Risk Assessment and ICH Q9)
• Experience with continuous improvement methodologies such as Lean or Six Sigma desire
• Familiarity with environmental monitoring equipment and purified water system design and validation

ROLE OVERVIEW:

The Cleaning Validation Specialist 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. The role is also responsible for managing the environmental and purified water monitoring programs to ensure product quality and safety throughout the manufacturing process.

CORE 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.