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Sr. Process & Facilities Engineer

Fremont, CA · Full time

Job Description

Responsible for URS creation and all other specs for all facilities equipment on which qualification is based

Responsible for GMP compliant detailed design for facility under quality change management and for construction satisfying design intent

Responsible for design and implementation of and controls for facilities equipment

Creation of protocols and execution of Commissioning, SAT, FAT for req’d systems

Sustains process equipment after construction. Executes all future (e.g. continuous improvement or NPI) changes to process equipment under GMP compliance

Follows GxP principles in troubleshooting equipment issues and ensures equipment is satisfying user (operations) requirements

Technical lead and primary point of contact between company and construction contractors + A/E firm(s) for process scope. Field RFIs, submittals, and other official communications between stakeholders.

Interface with city inspectors to interpret requests into design changes and drive compliance

Main technical interface with Validation Manager when VM is creating and executing qualifications

Supports RFP activities for engineering and construction activities

Supports establishing of procedures and processes for operation of facilities and interfaces with utilities and automation systems (BMS, EMS, Historian, etc)

Executes asset management and acts as system owner, defines preventive maintenance, and defines calibrations for utility systems

System owner for all facilities equipment

Qualifications/Skills required

At least 5 years experience performing duties of Process, Utilities, or Facilities Engineer

Bachelors degree in related field

Experience using CMMS systems in cGMP facilities

Experience managing facility systems and being system owner in cGMP environment

Excellent verbal and written communication skills with understanding of GDP needs

Experience interacting with regulatory agencies to defend the maintenance program is a plus+

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