View all jobs
Digital Plant Support Specialist
Carolina, PR · Biotech/PharmaceuticalGENERAL DESCRIPTION
Develop electronic batch records, executable forms and sequential logbooks for dry product manufacturing process in support of PR1 plant. Responsible to translate current manufacturing instructions to electronic batch records, paper-based forms into electronic forms and creation of electronic sequential logbooks in PMX platform, all while working with a multidisciplinary implementation team.
RESPONSIBILITIES
Under limited supervision and in accordance with the laws, federal regulations, and applicable state and local policies, procedures and guidelines of client, this position has the following tasks and duties.
1. Active participation on IDS/TSMS team meetings to provide input on project timeline considerations, activities, escalations and status of assigned tasks.
2. Evaluate and understand operational processes.
3. Evaluate paper forms, process and equipment cleaning instructions, and logbooks to convert into electronic records.
4. Assess work centers used in production areas.
5. Assess work centers equipment capability.
6. Serve as Subject Matter Expert to help the recipe authors for documentation construction and suggest path forward.
7. Revise and approve configuration documents.
8. Participate in the revision of the flow charts of the documentation records related to the manufacturing stages and steps.
9. Review of all PMX objects related to the documents.
10. Participate on objects verification on system, including issuance of summary of changes to ease the revision process.
11. Lead and/or participate on triage activities to assess change control requirements.
12. Issuance or support on change control generation.
13. Issuance change control and present it in Change Control Board to pursue approval of the change.
14. Review documentation associated to PMX production procedures (Core documents and their Attachments – Visio, Master Data, EQM, Choice list, History of changes (with TSMS), help with the issuance of the Proposed text’s history of changes.
15. Execute Test Scripts (informal), identify test script errors, and correct test scripts errors.
16. Issuance of Stabilization forms that may arise after transitioning from paper records to electronic records.
17. Revise equipment cleaning instructions while transferring them to electronic forms
18. Revise SOPs related to electronic record changes or new implementations.
19. Familiarize with PMX Objects update tracker to be used for transitioning activities.
20. Perform Informal testing and formal testing stages.
21. Execute Test Scripts and Test Scripts Data Sheet.
22. Execute Formal Testing in the Application Lifecycle Management (or similar platform) and assist in resolution of defects generation if any.
23. Revise Test Summary Report.
24. Participate /lead the electronic batch records and executable forms training preparation.
25. Lead trainings activities provided to manufacturing operators.
26. Participate and keep track on the Cutover plan.
27. Participate on objects transitioning activities and transition objects as needed.
28. Support On Call rotation after Go-live including issuance of stabilization forms.
29. 100% dedicated to the assigned electronic forms project (batch record and/or executable forms and/or logbook).
30. Comply with Individual Learning Plan Requirements including qualification modules for EBR, EQM, SAP,Trackwise,VEEVA (Quality Docs) among others.
31. Comply with additional tasks requested by supervisor.
REQUIREMENTS
BS in Science or Engineering
Minimum, 5 years experience as per responsibilities
*Weil Group is proud to be an Equal Employment Opportunity Employer.*
Develop electronic batch records, executable forms and sequential logbooks for dry product manufacturing process in support of PR1 plant. Responsible to translate current manufacturing instructions to electronic batch records, paper-based forms into electronic forms and creation of electronic sequential logbooks in PMX platform, all while working with a multidisciplinary implementation team.
RESPONSIBILITIES
Under limited supervision and in accordance with the laws, federal regulations, and applicable state and local policies, procedures and guidelines of client, this position has the following tasks and duties.
1. Active participation on IDS/TSMS team meetings to provide input on project timeline considerations, activities, escalations and status of assigned tasks.
2. Evaluate and understand operational processes.
3. Evaluate paper forms, process and equipment cleaning instructions, and logbooks to convert into electronic records.
4. Assess work centers used in production areas.
5. Assess work centers equipment capability.
6. Serve as Subject Matter Expert to help the recipe authors for documentation construction and suggest path forward.
7. Revise and approve configuration documents.
8. Participate in the revision of the flow charts of the documentation records related to the manufacturing stages and steps.
9. Review of all PMX objects related to the documents.
10. Participate on objects verification on system, including issuance of summary of changes to ease the revision process.
11. Lead and/or participate on triage activities to assess change control requirements.
12. Issuance or support on change control generation.
13. Issuance change control and present it in Change Control Board to pursue approval of the change.
14. Review documentation associated to PMX production procedures (Core documents and their Attachments – Visio, Master Data, EQM, Choice list, History of changes (with TSMS), help with the issuance of the Proposed text’s history of changes.
15. Execute Test Scripts (informal), identify test script errors, and correct test scripts errors.
16. Issuance of Stabilization forms that may arise after transitioning from paper records to electronic records.
17. Revise equipment cleaning instructions while transferring them to electronic forms
18. Revise SOPs related to electronic record changes or new implementations.
19. Familiarize with PMX Objects update tracker to be used for transitioning activities.
20. Perform Informal testing and formal testing stages.
21. Execute Test Scripts and Test Scripts Data Sheet.
22. Execute Formal Testing in the Application Lifecycle Management (or similar platform) and assist in resolution of defects generation if any.
23. Revise Test Summary Report.
24. Participate /lead the electronic batch records and executable forms training preparation.
25. Lead trainings activities provided to manufacturing operators.
26. Participate and keep track on the Cutover plan.
27. Participate on objects transitioning activities and transition objects as needed.
28. Support On Call rotation after Go-live including issuance of stabilization forms.
29. 100% dedicated to the assigned electronic forms project (batch record and/or executable forms and/or logbook).
30. Comply with Individual Learning Plan Requirements including qualification modules for EBR, EQM, SAP,Trackwise,VEEVA (Quality Docs) among others.
31. Comply with additional tasks requested by supervisor.
REQUIREMENTS
BS in Science or Engineering
Minimum, 5 years experience as per responsibilities
*Weil Group is proud to be an Equal Employment Opportunity Employer.*