Cleaning Validation Specialist

Job 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
Bachelors 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.**