Manager, Cleaning Validation

Overview:

 

The Manager, Cleaning Validationis responsible for leading and maintaining the cleaning validation program at Cambrex Charles City in support of active pharmaceutical ingredient (API) manufacturing operations. This role serves as the site subject matter expert for cleaning validation and cleaning verification, ensuring equipment and cleaning processes are appropriately designed, validated, documented, and maintainedin accordance with current Good Manufacturing Practices (cGMP), regulatory expectations, and Cambrex procedures. The manager provides technical and people leadership, supports regulatory inspection readiness, and partners across Manufacturing, Engineering, Quality Assurance, Quality Control, Analytical Development, Process Development, and Technical Services to implement scientifically sound, risk-based cleaning validation strategies.  

 

    Reports to: Director or Associate Director, Engineering / Validation  

 

    Direct Reports: Validation professionals and/or contract resources, as assigned  

 

    Role Type: First-line people manager with active technical and project responsibilities  

Responsibilities:

Leadership and People Management  

 

    Directly supervise, coach, and develop validation professionals and/or contractors supporting cleaning validation activities, as applicable.  

 

    Establish priorities, assign work, monitor progress, and ensure cleaning validation commitments are completed safely, compliantly, and on schedule.  

 

    Set performance expectations, support employee development, and provide technical guidance and training.  

 

    Communicate validation risks, project status, resource needs, and significant compliance or scheduling issues to site leadership.  

 

    Promote a culture of safety, accountability, collaboration, technical excellence, and continuous improvement.  

 

Cleaning Validation Program Leadership  

 

    Serve as the site subject matter expert for cleaning validation and cleaning verification activities.  

 

    Develop, implement, maintain, and continuously improve the site cleaning validation program, policies, procedures, templates, and standards.  

 

    Establish scientifically sound, risk-based validation strategies for manufacturing equipment, processes, products, and facilities.  

 

    Develop approaches for equipment grouping, product grouping, worst-case selection, sampling strategy, acceptance criteria, clean and dirty hold times, campaign length, and ongoing verification requirements.  

 

    Evaluate new products, processes, equipment, cleaning agents, and process changes to determine cleaning validation requirements before GMP implementation.  

 

    Ensure cleaning validation activities are integrated with change control, deviation, CAPA, equipment qualification, process validation, and the overall validation lifecycle.  

 

Validation Execution and Documentation  

 

    Lead the preparation, execution, review, and approval of cleaning validation master plans, protocols, studies, technical assessments, and final reports.  

 

    Ensure validation documentation is accurate, complete, scientifically justified, and compliant with cGMP requirements and Cambrex procedures.  

 

    Partner with Analytical Development and Quality Control on analytical methods used to identify and quantify residues from API manufacturing processes.  

 

    Establish acceptance limits and sampling plans based on toxicological or health-based exposure limits, product characteristics, process knowledge, equipment design, analytical capability, and regulatory expectations.  

 

    Assess manufacturing procedures, equipment configurations, cleaning instructions, analytical methods, and process changes for impact tovalidated cleaning processes.  

 

    Maintain lifecycle documentation and ensure validated status is preserved following equipment, product, process, or cleaning procedure changes.  

 

Technical Leadership and Risk Management  

 

    Lead quality risk assessments and gap analyses related to cleaning processes and validation requirements.  

 

    Investigate deviations, failures, atypical results, and adverse trends; determine root cause and ensure appropriate corrective and preventive actions are implemented.  

 

    Provide technical expertiseregarding equipment cleanability, hard-to-clean locations, sampling locations, cleaning parameters, residue limits, process controls, and validation strategy.  

 

    Use data and trend analysis to confirm the continued effectiveness and state of control of validated cleaning processes.  

 

    Identify opportunities to standardize cleaning approaches, reduce compliance risk, and improve validation efficiency without compromising product quality or patient safety.  

 

Cross-Functional, Regulatory, and Compliance Support  

 

    Partner with Manufacturing, Engineering, Quality Assurance, Quality Control, Analytical Development, Process Development, EHS, and Technical Services to execute validation activities.  

 

    Provide cleaning validation input for equipment design, modification, commissioning, qualification, technology transfer, new product introduction, and manufacturing process changes.  

 

    Support project teams and manufacturing schedules by coordinating validation scope, resources, timelines, and required documentation.  

 

    Ensure cleaning validation activities comply with cGMP, data integrity expectations, site procedures, and applicable FDA, ICH, and other regulatory requirements.  

 

    Support customer audits and regulatory inspections as the cleaning validation subject matter expert, including presentation of technical rationale and documentation.  

 

    Lead or support responses and remediation associated with validation-related audit findings or regulatory observations.  

 

    Maintain inspection readiness of cleaning validation records, procedures, and program governance. 

Qualifications / Skills::

•   Strong technical knowledge of cleaning validation, cleaning verification, and validation lifecycle management in pharmaceutical or API manufacturing.  
•     Knowledge of cGMP requirements, quality risk management, change control, deviation, CAPA, and data integrity principles.   
•     Understanding of pharmaceutical or chemical equipment cleaning, sampling techniques, residue testing, analytical methods, and health-based exposure limits.   
•     Strong technical writing, protocol development, investigation, root-cause analysis, and problem-solving skills.   
•     Demonstrated project management skills and ability to manage multiple priorities and timelines.   
•     Proven ability to lead cross-functional technical teams and communicate effectively with employees, leaders, customers, and regulatory inspectors.   
•     Strong attention to detail, sound technical judgment, and commitment to documentation quality and compliance. 

Qualifications:

 

 

•     Bachelor's degree in Chemical Engineering, Chemistry, Pharmaceutical Sciences, Biology, Engineering, or a related scientific or technical discipline required; advanced degree preferred.   
•     Minimum 7 years of relevant experience in pharmaceutical, biopharmaceutical, API, chemical, or other regulated manufacturing environments.   
•     Minimum 3 years of direct experience with cleaning validation, process validation, equipment validation, or related validation activities, including significant cleaning validation responsibility.   
•     At least 2 years of experience in a leadership, supervisory, technical lead, or project lead role preferred.   
•     Experience authoring and executing validation protocols, reports, risk assessments, investigations, and validation strategies required.   
•     Experience supporting FDA, customer, or other regulatory inspections preferred.   
•     Experience with API or small-molecule pharmaceutical manufacturing strongly preferred.