Position OverviewWe are seeking a
Cleaning Validation Specialist to support critical manufacturing operations at the solid dosage manufacturing site. This role will play a key part in
cleaning validation program execution and digital transformation initiatives, including the implementation of enhanced
data integrity practices and migration of cleaning documentation into a new digital platform.
The ideal candidate will bring strong
technical expertise in cleaning validation, combined with the ability to collaborate across multidisciplinary teams to improve processes, ensure compliance, and drive operational excellence.
Key Responsibilities- Actively participate in Cleaning Validation team meetings, providing updates on timelines, risks, and project status.
- Evaluate and understand manufacturing equipment cleaning processes and identify opportunities for improvement.
- Develop and execute cleaning validation protocols, reports, and executable instructions.
- Support digital transformation efforts by transferring paper-based cleaning documentation into a new digital platform.
- Assess and enhance data integrity controls within cleaning validation processes and documentation.
- Serve as Subject Matter Expert (SME) for cleaning validation activities and compliance requirements.
- Review and approve key documentation, including:
- Cleaning Validation Master Plans
- Risk Assessments
- Protocols and Reports
- SOPs and Work Instructions
- Lead and/or support change control activities, including:
- Impact assessments
- Change control generation
- Presentation to Change Control Board
- Participate in triage and risk assessment activities related to process or documentation changes.
- Review and optimize equipment cleaning instructions during digital platform migration.
- Support data integrity assessments and remediation actions for the cleaning program.
- Provide training to manufacturing personnel on cleaning processes and compliance requirements.
- Support on-call rotation for cleaning execution activities as required.
- Ensure compliance with training systems (e.g., Darwin, TrackWise, Veeva Quality Docs).
- Perform additional duties as assigned by leadership.
Qualifications- Bachelor's Degree in Engineering, Chemistry, Microbiology, or related Science field.
- 3-7+ years of experience in cleaning validation within pharmaceutical or regulated manufacturing environments.
- Strong knowledge of:
- cGMP / FDA regulations
- Cleaning validation lifecycle and strategies
- Data integrity principles (ALCOA+)
- Experience with:
- Protocol and report generation (IQ/OQ/PQ / CV)
- Risk assessments and limit calculations
- Change control systems (e.g., TrackWise)
- Document management systems (e.g., Veeva)
- Experience supporting digital platforms or paperless validation systems is highly preferred.
- Strong technical writing, analytical, and problem-solving skills.
- Fully bilingual (English / Spanish) with excellent communication skills.
- Ability to work independently with limited supervision and in cross-functional teams.
Preferred Qualifications- Experience in oral solid dosage (OSD) or similar manufacturing environments.
- Exposure to data integrity remediation projects.
- Previous experience leading training sessions or acting as SME.
