Cleaning Validation Engineer

Veranova L P•West Deptford, NJ

42d•$90,000 - $110,000

About The Position

The Cleaning Validation Engineer 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.

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, 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

Nice To Haves

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

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.

Benefits

Comprehensive health & wellness benefits.
Access to mental health resources and wellness programs.
Generous PTO and holiday pay policies.
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.
Opportunities for continuous learning through LinkedIn Learning, workshops, conferences, and mentorship.
Tuition Assistance for Undergraduate and Graduate degree programs.
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.