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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Bionova Scientific is an equal opportunity and affirmative action employer committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender identity or expression; affectional or sexual orientation; disability; veteran or military status, including protected veteran status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.