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Electronic Cleaning Validation Specialist
Carolina, PR · Biotech/PharmaceuticalWe have the need to recruit a resource to support the development and implementation of electronic cleaning validation protocol and executable forms in Kneat and Tulip platforms. In addition, the resource will support the activities related to the enhancement of data integrity requirements for the cleaning program and development of new digital platform to transfer and execute cleaning validation protocol and instructions.
A. GENERAL DESCRIPTION
Develop electronic cleaning validation protocols and forms, executable instructions in Kneat and Tulip platforms to support plant operations. Responsible to simplify documentation, transfer documentation to Kneat and Tulip, support implementation and stabilization period. Transfer of cleaning documentation to new digital platform, all while working with a multidisciplinary implementation team.
B. RESPONSIBILITIES
Under limited supervision and in accordance with the laws, federal regulations, and applicable state and local policies, procedures and guidelines, this position has the following tasks and duties.
1. Active participation on Cleaning Validation team meetings to provide input on projects timeline considerations, activities, escalations and status of assigned tasks.
2. Evaluate and understand cleaning processes.
3. Evaluate paper forms, protocols, process and equipment cleaning instructions to transfer them to new digital platform.
4. Identify opportunity to simplify instructions/documentation prior to transfer them to electronic system.
5. Assess work centers equipment capability and cleaning instructions for improvement purposes.
6. 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.
7. Revise and approve cleaning strategy documents.
8. Participate in the revision of the cleaning documentation records related to the manufacturing stages and steps.
9. Lead and/or participate on triage activities to assess change control requirements.
10. Issuance or support on change control generation and revision of standard operating procedure.
11. Issuance change control and present it in Change Control Board to pursue approval of the change.
12. Review documentation associated to cleaning program (cleaning validation master plan, risk assessment, protocols, reports, working instructions, sampling scheme, limit calculations, etc.).
13. Revise equipment cleaning instructions while transferring to new digital platform.
14. Revise SOPs related to cleaning program and requirements.
15. Participate /lead the data integrity assessment and actions for cleaning program.
16. Lead trainings activities provided to manufacturing operators.
17. Support On Call rotation for cleaning execution activities.
18. 100% dedicated to cleaning validation program
19. Comply with Individual Learning Plan Requirements including qualification modules for Darwin, Trackwise, VEEVA (Quality Docs) among others.
20. Comply with additional tasks requested by supervisor.
**Weil Group is proud to be an Equal Employment Opportunity Employer.**
A. GENERAL DESCRIPTION
Develop electronic cleaning validation protocols and forms, executable instructions in Kneat and Tulip platforms to support plant operations. Responsible to simplify documentation, transfer documentation to Kneat and Tulip, support implementation and stabilization period. Transfer of cleaning documentation to new digital platform, all while working with a multidisciplinary implementation team.
B. RESPONSIBILITIES
Under limited supervision and in accordance with the laws, federal regulations, and applicable state and local policies, procedures and guidelines, this position has the following tasks and duties.
1. Active participation on Cleaning Validation team meetings to provide input on projects timeline considerations, activities, escalations and status of assigned tasks.
2. Evaluate and understand cleaning processes.
3. Evaluate paper forms, protocols, process and equipment cleaning instructions to transfer them to new digital platform.
4. Identify opportunity to simplify instructions/documentation prior to transfer them to electronic system.
5. Assess work centers equipment capability and cleaning instructions for improvement purposes.
6. 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.
7. Revise and approve cleaning strategy documents.
8. Participate in the revision of the cleaning documentation records related to the manufacturing stages and steps.
9. Lead and/or participate on triage activities to assess change control requirements.
10. Issuance or support on change control generation and revision of standard operating procedure.
11. Issuance change control and present it in Change Control Board to pursue approval of the change.
12. Review documentation associated to cleaning program (cleaning validation master plan, risk assessment, protocols, reports, working instructions, sampling scheme, limit calculations, etc.).
13. Revise equipment cleaning instructions while transferring to new digital platform.
14. Revise SOPs related to cleaning program and requirements.
15. Participate /lead the data integrity assessment and actions for cleaning program.
16. Lead trainings activities provided to manufacturing operators.
17. Support On Call rotation for cleaning execution activities.
18. 100% dedicated to cleaning validation program
19. Comply with Individual Learning Plan Requirements including qualification modules for Darwin, Trackwise, VEEVA (Quality Docs) among others.
20. Comply with additional tasks requested by supervisor.
**Weil Group is proud to be an Equal Employment Opportunity Employer.**