Create & maintain system specifications for black utilities
Support all design, installation, commissioning, qualification, training activities for black utilities, as system owner/expert
Provide additional technical support to project team as required
Adhere to all Quality & environmental regulations within area of responsibility
Support technical development of Facilities Technicians after handover to LOB
Continuous process improvement using cLEAN® concepts
Maintain & establish standards for procedures & maintenance plans
All safety & environmental requirements in the performance of duties
Requirements
Bachelor's Degree in Mechanical, Electrical or Chemical Engineering or equivalent combination of education & experience required
Minimum of 8 years engineering experience in a manufacturing facility.
Knowledge & experience in the operations, maintenance, & design of cGMP utilities as well as working in a regulated environment (FDA, cGMP, OSHA) preferred
Thorough knowledge of black utilities systems to include: chilled water, plant steam, compressed air, vacuum, waste water, cryogenic storage, HVAC.
Demonstrated ownership and innovation of black utility systems required
Knowledgeable in clean utilities systems to include: WFI, pure water, clean steam, process air, electrical required
Ability to read/review design drawings (CAD) with a basic understanding of P&ID, HVAC, & Electrical systems required
Thorough understanding of technical documents such as URS, SAT, FAT, Validation Protocols preferred
Thorough understanding of complicated product documentation & standard operating procedures with attention to high-level concepts required
Computer literacy with associated systems preferred
Demonstrated knowledge and proficiency in change control processes and familiarity with validation and commissioning methodology and processes required
Proven expertise in planning/organization/execution of project & maintenance activities, following up on results & revising the work plan for complex problems being resolved by cross functional teams preferred
Benefits
Leading pay and annual performance bonus for all positions
All employees enjoy generous paid time off including 14 paid holidays
Health Insurance, Dental Insurance, Vision Insurance – effective day one
Guaranteed 8% 401K contribution plus individual company match option
Family Focused Benefits including 14 weeks paid parental & 6 weeks paid family medical leave
Free access to Novo Nordisk-marketed pharmaceutical products