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Cleaning Validation Specialist
Carolina, PR · Biotech/PharmaceuticalJob Posting: Cleaning Validation Specialist / Cleaning Validation SME
We are seeking a Cleaning Validation Specialist / Subject Matter Expert (SME) to provide dedicated support to the Cleaning Validation Program within a regulated pharmaceutical or biotechnology manufacturing environment. The selected resource will be 100% dedicated to cleaning validation activities, including documentation review, protocol and form development, digital platform implementation, data integrity assessments, change controls, SOP revisions, training support, and execution-related activities.
Key Responsibilities
The Cleaning Validation Specialist / SME will be responsible for supporting the following activities:
• Actively participate in Cleaning Validation team meetings and provide input regarding project timelines, task status, activities, escalations, and project execution considerations.
• Evaluate and understand manufacturing equipment cleaning processes and cleaning requirements.
• Review paper forms, protocols, process instructions, and equipment cleaning instructions to support their transfer to new digital platforms.
• Identify opportunities to simplify cleaning instructions and documentation prior to transfer into electronic systems.
• Assess work centers, equipment capabilities, and cleaning instructions to identify improvement opportunities.
• Serve as Subject Matter Expert for the development and implementation of cleaning protocols and forms in Kneat and Tulip platforms.
• Support the implementation of additional data integrity requirements related to the cleaning validation program.
• Review and approve cleaning strategy documents.
• Participate in the review of cleaning documentation records related to manufacturing stages and process steps.
• Lead and/or participate in triage activities to assess change control requirements.
• Issue and/or support the generation of change controls and the revision of standard operating procedures.
• Prepare and present change controls in the Change Control Board to obtain approval.
• Review documentation associated with the cleaning validation program, including Cleaning Validation Master Plans, risk assessments, protocols, reports, working instructions, sampling schemes, limit calculations, and related documents.
• Review equipment cleaning instructions during their transfer to new digital platforms.
• Review SOPs related to the cleaning program and cleaning validation requirements.
• Participate in and/or lead Data Integrity assessments and corresponding action items for the cleaning program.
• Lead training activities provided to manufacturing operators.
• Support on-call rotation for cleaning execution activities, as required.
• Comply with Individual Learning Plan requirements, including qualification modules for Darwin, TrackWise, Veeva QualityDocs, and other applicable systems.
• Perform additional tasks as requested by the supervisor.
Required Qualifications and Experience
• Bachelor’s degree in Science, Engineering, Microbiology, Chemistry, Biotechnology, Pharmacy, or a related technical field.
• Experience in Cleaning Validation within a pharmaceutical, biotechnology, or regulated manufacturing environment.
• Knowledge of cleaning validation documentation, including protocols, reports, risk assessments, sampling schemes, limit calculations, cleaning instructions, and SOPs.
• Experience reviewing and improving cleaning documentation and equipment cleaning instructions.
• Experience supporting change controls, SOP revisions, documentation updates, and quality system requirements.
• Knowledge of Data Integrity principles and their application to validation and GMP documentation.
• Ability to assess cleaning processes, equipment capabilities, and documentation requirements.
• Strong technical writing, documentation review, and communication skills.
• Ability to work cross-functionally with Manufacturing, Quality, Validation, Engineering, and Digital/Systems teams.
• Availability to support on-call rotation for cleaning execution activities, as required.
Preferred Qualifications
• Experience with Kneat platform.
• Experience with Tulip platform.
• Experience with TrackWise, Veeva QualityDocs, Darwin, or similar GMP documentation and quality systems.
• Previous experience serving as SME for cleaning validation, cleaning documentation remediation, or digital transformation of validation records.
• Experience leading operator training related to cleaning processes, cleaning documentation, or new digital systems.
• Experience presenting change controls in Change Control Board meetings.
Desired Skills
• Strong knowledge of GMP requirements and cleaning validation expectations.
• Ability to identify documentation simplification and process improvement opportunities.
• Strong organizational skills and attention to detail.
• Ability to manage multiple priorities and assigned tasks within established timelines.
• Strong problem-solving and critical thinking skills.
• Ability to work independently while maintaining alignment with project and compliance requirements.
**Weil Group is proud to be an Equal Employment Opportunity Employer.**
We are seeking a Cleaning Validation Specialist / Subject Matter Expert (SME) to provide dedicated support to the Cleaning Validation Program within a regulated pharmaceutical or biotechnology manufacturing environment. The selected resource will be 100% dedicated to cleaning validation activities, including documentation review, protocol and form development, digital platform implementation, data integrity assessments, change controls, SOP revisions, training support, and execution-related activities.
Key Responsibilities
The Cleaning Validation Specialist / SME will be responsible for supporting the following activities:
• Actively participate in Cleaning Validation team meetings and provide input regarding project timelines, task status, activities, escalations, and project execution considerations.
• Evaluate and understand manufacturing equipment cleaning processes and cleaning requirements.
• Review paper forms, protocols, process instructions, and equipment cleaning instructions to support their transfer to new digital platforms.
• Identify opportunities to simplify cleaning instructions and documentation prior to transfer into electronic systems.
• Assess work centers, equipment capabilities, and cleaning instructions to identify improvement opportunities.
• Serve as Subject Matter Expert for the development and implementation of cleaning protocols and forms in Kneat and Tulip platforms.
• Support the implementation of additional data integrity requirements related to the cleaning validation program.
• Review and approve cleaning strategy documents.
• Participate in the review of cleaning documentation records related to manufacturing stages and process steps.
• Lead and/or participate in triage activities to assess change control requirements.
• Issue and/or support the generation of change controls and the revision of standard operating procedures.
• Prepare and present change controls in the Change Control Board to obtain approval.
• Review documentation associated with the cleaning validation program, including Cleaning Validation Master Plans, risk assessments, protocols, reports, working instructions, sampling schemes, limit calculations, and related documents.
• Review equipment cleaning instructions during their transfer to new digital platforms.
• Review SOPs related to the cleaning program and cleaning validation requirements.
• Participate in and/or lead Data Integrity assessments and corresponding action items for the cleaning program.
• Lead training activities provided to manufacturing operators.
• Support on-call rotation for cleaning execution activities, as required.
• Comply with Individual Learning Plan requirements, including qualification modules for Darwin, TrackWise, Veeva QualityDocs, and other applicable systems.
• Perform additional tasks as requested by the supervisor.
Required Qualifications and Experience
• Bachelor’s degree in Science, Engineering, Microbiology, Chemistry, Biotechnology, Pharmacy, or a related technical field.
• Experience in Cleaning Validation within a pharmaceutical, biotechnology, or regulated manufacturing environment.
• Knowledge of cleaning validation documentation, including protocols, reports, risk assessments, sampling schemes, limit calculations, cleaning instructions, and SOPs.
• Experience reviewing and improving cleaning documentation and equipment cleaning instructions.
• Experience supporting change controls, SOP revisions, documentation updates, and quality system requirements.
• Knowledge of Data Integrity principles and their application to validation and GMP documentation.
• Ability to assess cleaning processes, equipment capabilities, and documentation requirements.
• Strong technical writing, documentation review, and communication skills.
• Ability to work cross-functionally with Manufacturing, Quality, Validation, Engineering, and Digital/Systems teams.
• Availability to support on-call rotation for cleaning execution activities, as required.
Preferred Qualifications
• Experience with Kneat platform.
• Experience with Tulip platform.
• Experience with TrackWise, Veeva QualityDocs, Darwin, or similar GMP documentation and quality systems.
• Previous experience serving as SME for cleaning validation, cleaning documentation remediation, or digital transformation of validation records.
• Experience leading operator training related to cleaning processes, cleaning documentation, or new digital systems.
• Experience presenting change controls in Change Control Board meetings.
Desired Skills
• Strong knowledge of GMP requirements and cleaning validation expectations.
• Ability to identify documentation simplification and process improvement opportunities.
• Strong organizational skills and attention to detail.
• Ability to manage multiple priorities and assigned tasks within established timelines.
• Strong problem-solving and critical thinking skills.
• Ability to work independently while maintaining alignment with project and compliance requirements.
**Weil Group is proud to be an Equal Employment Opportunity Employer.**