Bionova is seeking a motivated and innovative Associate Process & Facilities Engineer to serve in the Facilities and Engineering department. As part of the F&E group, you will have opportunities to work on and take ownership of a wide range of projects from system and workflow implementation, to facility and laboratory capital buildouts, troubleshooting and investigations, maintenance and calibration program management. Bionova is currently expanding its capabilities from a CDO to a CDMO through construction of a GMP manufacturing facility and QC testing laboratory. As part of the F&E team, you will drive cross-functional decisions and influence decisions of user teams as we grow the organization and expand capabilities to meet project goals that ultimately improve patient outcomes.
Duties & Responsibilities
- Responsible for specifications for all facilities and equipment on which qualification is based (e.g. user requirements specifications)
- Assist in GMP compliant detailed design for facility under quality change management and for construction satisfying design intent
- Facilitate and own as required the design and implementation of and controls for facilities equipment
- Creation of protocols for and oversight of Commissioning, SAT, FAT for utility and process systems
- Sustains process equipment after construction. Executes (e.g. continuous improvement or NPI) changes to process equipment under QA oversight (GMP compliance)
- Follows GxP principles in troubleshooting equipment issues and ensures equipment is satisfying user (operations) requirements
- Act as primary point of contact between company and construction contractors + A/E firm(s) for process scope. Field RFIs, submittals, and other official communications between construction stakeholders.
- Main technical interface with Validation Manager (VM) when VM is creating and executing qualifications
- Supports RFP activities for design and construction phases of projects
- Support establishing of procedures and processes for operation of facilities and interfaces with utilities and automation systems (BMS, EMS, Historian, CMMS, etc.)
- Executes asset management and acts as system owner, defines preventive maintenance for new assets, and defines calibrations for utility systems
- System owner for specific facilities equipment
- At least 2 years experience performing duties of Process, Utilities, or Facilities Engineer
- Bachelors degree in related field
- Excellent verbal and written communication skills with understanding of GDP needs
- Experience using CMMS systems in cGMP facilities
- Experience managing facility systems and being system owner in cGMP environment
- Experience interacting with regulatory agencies to defend Quality Systems
- Must be legally authorized to work in the United States without restriction.
- Must be willing to submit to a background investigation, including verification of your past employment, criminal history, and educational background.
- Must be willing to take a drug test and post-offer physical (if required).
- Must be 18 years of age or older.
Ready to Apply?
Please use the form below to submit your cover letter and resume.
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.