Cleaning Validation Specialist (Digital Platforms)

QRC Group, LLC • Carolina, PR

3d

About The Position

We are seeking an experienced Cleaning Validation Specialist to support the digital transformation of cleaning validation processes. This role focuses on transferring and executing cleaning validation protocols using Kneat and Tulip platforms, while enhancing data integrity requirements and improving existing documentation and processes.

Requirements

• Bachelor’s Degree in Science (Chemistry, Microbiology, Engineering, or related field)
• Proven expertise in Cleaning Validation (pharmaceutical or regulated industries preferred)
• Hands-on experience with Kneat and/or Tulip platforms
• Strong understanding of data integrity principles (ALCOA+)
• Bilingual: English and Spanish (required)

Responsibilities

• Active participation on Cleaning Validation team meetings to provide input on projects timeline considerations, activities, escalations and status of assigned tasks.
• Evaluate and understand cleaning processes.
• Evaluate paper forms, protocols, process and equipment cleaning instructions to transfer them to new digital platform.
• Identify opportunity to simplify instructions/documentation prior to transfer them to electronic system.
• Assess work centers equipment capability and cleaning instructions for improvement purposes.
• Serve as Subject Matter Expert to develop and implement cleaning protocol and forms in Kneat and Tulip platforms, together with implementation of additional data integrity requirements.
• Revise and approve cleaning strategy documents.
• Participate in the revision of the cleaning documentation records related to the manufacturing stages and steps.
• Lead and/or participate on triage activities to assess change control requirements.
• Issuance or support on change control generation and revision of standard operating procedure.
• Issuance change control and present it in Change Control Board to pursue approval of the change.
• Review documentation associated to cleaning program (cleaning validation master plan, risk assessment, protocols, reports, working instructions, sampling scheme, limit calculations, etc.).
• Revise equipment cleaning instructions while transferring to new digital platform.
• Revise SOPs related to cleaning program and requirements.
• Participate /lead the data integrity assessment and actions for cleaning program.
• Lead training activities provided to manufacturing operators.
• Support On Call rotation for cleaning execution activities.
• 100% dedicated to cleaning validation program

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level