Clinical Manufacturing Lead I/II

4 weeks ago


North Chicago Illinois, United States AbbVie Full time
Job Description

System owner for essential production systems like SAP, factory flow, and shift connect for API Pilot Plant. 

Lead the implementation and customization of those essential production systems in API Pilot Plant.

Manage/develop/update SOP’s, training CBT’s/materials, and provide hands-on training for pilot plant staff.

Provides meaningful assistance with troubleshooting and identifies solutions to issues that arise during manufacturing.

Interface between API pilot plant and BTS functions to improve existing manufacturing systems and develop new applications.  Clearly communicate pilot plant needs and timeline with BTS functions.

Partner with Operations, Tech Ops, Plant Engineering teams to evaluate and implement new manufacturing systems and/or automation solutions, e.g.  scale-SAP integration, electronic batch records, etc. Identify opportunities to modify or leverage existing assets to enhance operational efficiency.

Advise pilot plant leadership on the strength and weakness of existing systems and the next generation technology for investment.

Support the implementation, customization, training, and troubleshooting of the other documentation archiving systems used in API pilot plant, e.g. One Vault, Valgene, Share Point, etc.

Collaborate with trainers on procedure updates and staff training as needed.

Follows cGMP requirements, established policies, procedures, and practices; Follows established safety requirements.



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