ECQ Engineer
Core
Execute and supervise equipment calibration, preventative maintenance, performance verification, and repair activities in laboratory and manufacturing areas to support pharmaceutical operations.
Role type
Equipment Engineer (ECQ Operations)
Builds
Laboratory and commercial manufacturing equipment reliability and compliance
Domain
Pharmaceutical manufacturing / Laboratory operations
Deliverable
infrastructure
Required skills
cGMP/GXP/GAMP knowledge, FDA-regulated industry experience, maintenance coordination, calibration management, environmental monitoring, deviation writing, investigation support, CMMS data entry, vendor record review, procedure development
Preferred skills
BS in Engineering or Science, benchtop manufacturing equipment experience (cell counters, liquid handlers, Flow Cytometry, UPLC, HPLC), commercial environment experience
Technologies
Microsoft Office Suite, Blue Mountain RAM, site CMMS
Responsibilities
Execute and supervise equipment calibration, preventative maintenance, performance verification and repair activities; Review and approve vendor-executed calibration, maintenance and repair records; Enter and maintain data in the site CMMS system; Write and support deviations, investigations, and corrective/preventative actions; Support development, revision and review of procedures, calibration plans, and maintenance plans; Respond to customer equipment support requests; Maintain required Corporate, Facilities and EHS training
Seniority
Mid-level, hands-on IC