Senior Manager Cleaning Validation

Role Summary

Senior Manager Cleaning Validation located in Devens, MA. Leads the cleaning validation program, ensuring regulatory alignment and industry best practices. This role requires collaboration across Manufacturing, Quality, and Laboratory teams and may involve audits, cleanroom work, and occasional travel.

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.
• May require working in cleanrooms and controlled environments 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, receiving high-level goals from incumbent's supervisor and exercising considerable latitude in execution.

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 industry).
• Hands-on experience executing validation protocols, supporting routine 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.