What are the responsibilities and job description for the Process Engineer position at Abacus?
Description / Comment : - ONSITE - DURATION - 3 MONTHS - SHIFT - MON-FRIDAY - 8AM TO 5PM - MUST HAVE - DRUG SUBSTANCE, MAXIMO, TRACKWISE, EDMS / MES EXP. PREFERS - SITE EXP, ALREADY HAVE A LOGIN INTO OUR MAXIMO, TRACKWISE, EDMS / MES.
Support engineering activities.
Development and / or maintenance of deliverable tracking and project schedule
Equipment and process change control authoring and management, as needed
uthoring and management of engineering, operational, and validation life cycle documents such as user requirement specifications, criticality assessments, drawings, commissioning test plans and summary reports, asset information sheets, maintenance / calibration plans, spare part plans, operating procedures, and safety documentation, as needed
Coordination and execution of engineering testing and training activities with end users, as needed
Coordination of validation IQOQPQ activities, as needed
Validation / qualification testing, documentation authoring, or execution, as needed
Management of project closeout and file transfer activities
Responsible for :
- Validation and qualification activities to support the qualification of
o Eight single-use bioreactors,
o Two chromatography skids,
o Two single-use mixers,
o other miscellaneous equipment.
Validation / Process Engineer
TYPICAL MINIMUM EDUCATION AND / OR EXPERIENCE :
