Cleaning Validation Specialist
About The Position
Under limited supervision, this position has the following tasks and duties. Active participation in 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 purposes. 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 to the 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 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
- Bachelor’s Degree in Science or Engineering (Chemistry, Microbiology, Chemical Engineering, Biomedical Engineering, or related field).
- Training or certifications aligned with quality systems, validation, or data integrity (Darwin, TrackWise, VEEVA/Quality Docs) as required by the role.
- 3–7 years of experience in Cleaning Validation within pharmaceutical, biotechnology, or other regulated manufacturing environments
- Experience developing and reviewing Cleaning Validation Protocols & Reports
- Experience developing and reviewing Cleaning Validation Master Plans
- Experience developing and reviewing Risk Assessments
- Experience developing and reviewing Sampling Schemes
- Experience developing and reviewing Working Instructions
- Experience developing and reviewing Limit Calculations
- Experience developing and reviewing Equipment Cleaning Instructions
- Experience developing and reviewing SOPs related to cleaning programs
- Strong knowledge of Cleaning processes and acceptance criteria
- Strong knowledge of Equipment and work center assessments for cleaning capability
- Strong knowledge of Sampling procedures (swab/rinse) and limit calculations
- Strong knowledge of Regulated documentation and change control processes
- Strong knowledge of Data integrity principles applied to cleaning (ALCOA+)
- Ability to evaluate existing documents (protocols, forms, instructions) and transfer them to digital platforms.
- Experience participating in and presenting to Change Control Boards.
- Proficiency with Darwin
- Proficiency with TrackWise
- Proficiency with VEEVA (Quality Docs)
- Proficiency with Digital documentation and execution platforms
- Ability to lead meetings, training, and technical activities.
- Strong attention to detail in documentation review and regulatory compliance.
- Ability to work with limited supervision.
- Strong teamwork and communication skills across functions such as Manufacturing, QA, Engineering, etc.
- Availability to support on-call rotation as required.
- 100% dedication to the Cleaning Validation Program.
- Ability to comply with additional tasks assigned by the supervisor.
- Participation in triage activities to determine change control requirements.
- Ability to lead or support data integrity assessments within the cleaning program.
Responsibilities
- Active participation in Cleaning Validation team meetings
- 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 purposes
- 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 to the Change Control Board to pursue approval of the change
- Review documentation associated to cleaning program
- 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
- Comply with Individual Learning Plan Requirements
- Comply with additional tasks requested by supervisor
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
