Veranova L P-posted 2 months ago
Full-time • Mid Level
Devens, MA
501-1,000 employees

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. You’ll 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, you’ll manage the environmental and purified water monitoring programs to ensure consistent product quality throughout the process.

  • 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.
  • 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.
  • 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.
  • Comprehensive health & wellness benefits.
  • Access to mental health resources and wellness programs.
  • Generous PTO and holiday pay policies.
  • Comprehensive total compensation package that includes competitive base salary.
  • Defined Contribution Pension program.
  • Eligibility for performance-based bonuses.
  • Attractive 401(k) Plan with company match.
  • Opportunities for continuous learning through LinkedIn Learning, workshops, conferences, and mentorship.
  • Tuition Assistance for Undergraduate and Graduate degree programs.
  • An inclusive culture integral to our values.
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