Cleaning Validation Engineer

Who We Are:

At Veranova we believe people are our most important asset and we are dedicated to building the most talented and diverse 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.

Role Overview:

This role serves as the site SME for all cleaning validation and verification activities related to intermediate and API manufacturing including facility surfaces and equipment. Youll work closely with cross-functional teams to ensure regulatory compliance and implement effective cleaning strategies that meet customer expectations. This position is key to maintaining high quality and safety standards across manufacturing operations. Additionally youll manage the environmental and purified water monitoring programs to ensure consistent product quality throughout the 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.

Qualifications:

• 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 and a mindset that promotes a positive work culture
• 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
• 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
• 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
• Experience in a fast-paced work environment

Preferred

• 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

Salary Range: $90000 - $100000 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 reflectthe 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 our privacy notice.