Job Description

Develop cleaning validation studies, protocols and reports, executable instructions in support of plant operations. Responsible to support risk assessments and implement data integrity requirements to the executable cleaning instructions, transfer of cleaning documentation to new digital platform, all while working with a multidisciplinary implementation team.

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.
• Assess work centers equipment capability and cleaning instructions for improvement purpose.
• Serve as Subject Matter Expert to develop cleaning validation protocols, reports, executable instructions and 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.
• 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 trainings activities provided to manufacturing operators.
• Support On Call rotation for cleaning execution activities.
• Comply with Individual Learning Plan Requirements including qualification modules for Darwin, Trackwise, VEEVA (Quality Docs) among others.
• Comply with additional tasks requested by supervisor.

Requirements

Basic Qualifications

• Bachelor’s degree in Engineering, Life Sciences, or related technical field.
• Experience in cleaning validation within a pharmaceutical, biotechnology, or regulated manufacturing environment.
• Knowledge of GMP regulations and data integrity principles.

Preferred Qualifications

• Experience with digital quality systems such as TrackWise, Veeva, or similar platforms.
• Experience developing validation protocols and reports.
• Strong technical writing and documentation skills.
• Experience supporting change control processes.

Benefits

• Contract position with possible extension