Facilities Engineer 2

Role Overview

• Support a variety of facilities equipment supporting manufacturing, critical business functions and administrative areas.
• Helps provides direct input into the CMMS, SAP/EAM, to ensure health of the asset throughout the lifecycle. Examples of input include onboarding equipment, uploading maintenance plans, task lists and key calibration parameters.
• Work closely with maintenance mechanics assisting in complex equipment breakdowns.
• Provides direct input to Siemens Desigo BMS/EMS system
• Inspects work to assure compliance with plans and specifications.
• Ensures project documents are complete, current, and stored appropriately.
• Reviews architectural and engineering drawings to ensure that all specifications and regulations are being followed.
• Provide reports and presentations on proposed projects and policies.
• Perform other duties as assigned.
• Maintain reliability systems and programs to improve uptime.
• Track and analyze historical data of operations and KPIs.
• Provide input for continuous improvement in the areas of facilities and engineering.
• Provide input and author SOPs, Validation Protocols, Deviations, CAPAs and other GMP documentation.
• Generation of specifications and other engineering documents as used for equipment design and qualification.
• Provide input on procedures for equipment maintenance and calibration.
• Analysis of equipment metrics to support continuous improvement efforts.
• Support of engineering change control for new equipment design and modification.
• Creation of impact assessments for equipment changes.
• Support of internal processes to ensure regulatory compliance is maintained.
• Daily operational support as needed.
• Cross-functional collaboration to complete projects and solve problems.

Requirements

• Typically Requires a minimum of 2 years of related experience with a bachelor’s degree or technical schooling; or a master’s degree; or equivalent work experience in Industrial Engineering, Mechanical Engineering, Electrical Engineering or HVAC/Controls.
• Ideal candidate will have professional knowledge with Siemens BMS Desigo CC Master Operator, HMI
• Familiarity with related quality standards (ISO 13485, 21 CFR 820, etc.) for implementation and review.
• Understanding of a risk-based approach to Commissioning, Qualification and Validation (CQV) of Facilities, Utilities and Equipment (FUE) in a medical device and/or drug GMP environment
• Experience working cross-functionally to develop technical requirements
• Experience in clean rooms, RODI, HVAC and other systems used to support a regulated manufacturing environment
• Experience creating master validation plans, protocols, and reports
• Experience with Siemens building automated programs such as Insight or Desigo.
• Must be well-versed with Microsoft Office products such as Word, Excel, and Outlook
• Must be able to read construction drawings and blueprints
• Understanding of the entire design, construction, and contracting processes
• Familiar with AutoCAD, Revit, and Bluebeam
• Demonstrated analytical and problem-solving skills
• Strong oral and written communication skills
• Highly organized and detailed-oriented, with superior data analysis/synthesis skills, both quantitative and qualitative
• Good design, research, writing and verbal communication skills.

Benefits

• access to genomics sequencing
• family planning
• health/dental/vision
• retirement benefits
• paid time off