Main Responsibilities:
Duration will be – starting as early as Sep 2023, ending Jun 2024. (potential to extend longer)
Draft SDLC document (automation specific) such as configuration specification, automation IQ, automation OQ, etc.
Execute Automation IQ and Automation OQ in the field.
Identify issues during the AIQ/AOQ execution and resolve to correction via a change control
Open/close change control including drafting of the change control, make/follow the correction, update documents as needed following the change control procedure.
Draft requirement traceability
list of equipment in the scope are vial/syringe filling line, Lyophilizer, isolator, glove tester, autoclave, parts washer, sterilizer, BAS to name a few.
Desired - Experience and Education:
2-3 years in Automation validation experience in pharmaceutical, GMP environment.
Good written and verbal communication skills. Professional, detail-orientated.
Able to work in a group and independently.
Salary: Competitive Salary offerings
Benefits: Paid Leave, 401-K, Group Medical, Dental, Vision, Life, AD&D, etc.