Senior Manager Cleaning Validation

Role Summary

Senior Manager Cleaning Validation – Devens, MA. Lead the cleaning validation program, ensuring regulatory compliance and alignment with industry best practices, while collaborating with cross-functional teams to maintain validated cleaning processes.

Responsibilities

• Provide strategic oversight and management of the cleaning validation program, ensuring alignment with regulatory requirements and industry best practices.
• Develop, write, and execute cleaning validation protocols, reports, and risk assessments.
• Establish acceptance criteria and sampling plans for cleaning verification and validation.
• Delegate tasks and coordinate the execution of cleaning studies, ensuring timely and effective completion.
• Optimize and update cleaning validation strategies and procedures to reflect current industry standards and regulatory expectations.
• Perform swab and rinse sampling, cleanability, degradation and sampling recovery studies reviewing analytical results against acceptance limits.
• Support investigations related to cleaning failures, deviations, and non-conformances.
• Collaborate with Manufacturing, Quality, and Laboratory teams to ensure validated state of cleaning processes.
• Ensure compliance with regulatory guidelines (FDA, EMA, cGMP, ICH) and internal SOPs.
• Participate in audits and inspections, providing subject matter expertise in cleaning validation.
• Maintain up-to-date knowledge of industry best practices and regulatory expectations for cleaning validation.
• Lead and support projects involving new product introductions, equipment changes, or process improvements related to cleaning.
• Author and revise Standard Operating Procedures (SOPs) related to cleaning validation and verification activities.
• Regular collaboration with Manufacturing, Quality Assurance, QC Laboratory, Engineering, and Validation teams.
• May interact with regulatory inspectors, third-party laboratories, consultants, and equipment/cleaning agent vendors.
• Based in a GMP-regulated manufacturing or laboratory environment and may require working in cleanrooms with appropriate gowning and PPE.
• Occasional requirement to work evenings, weekends, or during production shutdowns to support validation activities; some travel may be required to support multi-site projects or audits.
• Determines appropriate cleaning validation approaches based on regulatory requirements, risk assessments, and product/equipment needs.
• Exercises judgment in troubleshooting cleaning validation failures and recommending corrective actions.
• Provides input into and makes decisions related to new equipment, cleaning agents, or cleaning procedures.
• Ensures decisions balance compliance, product safety, and operational efficiency.
• This position is largely self-directed, with high-level goals and considerable latitude in execution; may require independent decision-making and prioritization.

Qualifications

• Bachelor's degree in engineering or related discipline required; advanced degree preferred.
• 8+ years of experience in cleaning validation, process validation, or a related GMP environment (pharmaceutical, biotechnology, or medical device).
• Hands-on experience executing validation protocols, supporting lifecycle maintenance, and responding to compliance requirements.
• Strong knowledge of cGMP, FDA, EMA, and ICH cleaning validation requirements.
• Experience with analytical methods such as HPLC, TOC, or microbiological techniques is preferred.
• Demonstrated ability to manage and optimize cleaning validation programs.
• Strong technical writing and documentation skills.
• Excellent problem-solving, analytical, and communication skills.
• Proven ability to execute, delegate tasks and oversee execution of cleaning studies.
• Ability to work independently as well as collaboratively in a cross-functional team.

Skills

• Cleaning validation program management
• Regulatory compliance (FDA, EMA, ICH, cGMP)
• Validation protocol development and execution
• Analytical methods (HPLC, TOC, microbiology)
• Risk assessment and mitigation
• Technical writing and SOP development
• Cross-functional collaboration
• Problem-solving and analytical thinking

Education

• Bachelor's degree in engineering or related discipline (required); advanced degree preferred.

Additional Requirements

• Based in a GMP-regulated environment; may involve cleanrooms and PPE.
• Occasional travel for multi-site projects or audits.