Cleaning Validation Specialist - Transformation Leader

Technical Engineering Consulting; Carolina (PR); On-site; USD 90,000 - 130,000; Full time

Job summary

Technical Engineering Consulting is seeking a Cleaning Validation Specialist to support critical manufacturing operations at a solid dosage site, driving cleaning validation program execution and digital transformation. You will collaborate with cross-functional teams to ensure compliance with cGMP, implement data integrity controls, and migrate paper-based documentation into a new digital platform.

The role includes SME responsibilities, change control support, and training of manufacturing

Qualifications

• Bachelor’s degree in engineering, chemistry, microbiology, or related science.
• 3–7+ years in cleaning validation in pharma/manufacturing.
• Experience with cGMP/FDA regulations and data integrity (ALCOA+).
• Experience with protocol/report generation (IQ/OQ/PQ/CV).
• Familiar with TrackWise and Veeva for document management.
• Fully bilingual English/Spanish.

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 SME for cleaning validation activities and compliance requirements.
• Review and approve key documentation including Master Plans, Risk Assessments, Protocols and Reports, SOPs and Work Instructions.
• Lead and/or support change control activities including impact assessments, change control generation, and presenting 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.

Skills

Cleaning validation

cGMP/FDA regulations

Data integrity (ALCOA+)

Technical writing

Bilingual English/Spanish

Cross-functional collaboration

Independent work

Education

Bachelor’s Degree in Engineering, Chemistry, Microbiology, or related Science

Tools

TrackWise

Veeva

IQ/OQ/PQ/CV

Job description

Technical Engineering Consulting is seeking a Cleaning Validation Specialist to support critical manufacturing operations at a solid dosage site, driving cleaning validation program execution and digital transformation. You will collaborate with cross-functional teams to ensure compliance with cGMP, implement data integrity controls, and migrate paper-based documentation into a new digital platform.

The role includes SME responsibilities, change control support, and training of manufacturing