Facilities Engineer 2

This role will be responsible for providing technical expertise as related to mechanical systems within facilities equipment engineering, support maintenance, and/or calibration and equipment performance optimization. Including projects related to mechanical, electrical, and plumbing (MEP) systems in an FDA regulated environment. The individual will possess technical knowledge of facilities water purification (RO/DI) skids, HVAC, Chillers, Cooling Towers, Boilers, centralized gas distribution systems, walk-in cold storage units, clean rooms, BMS/EMS system, Electrical generation and distribution system and other plant utilities, facilities validation, as well as construction management skills.

Responsibilities:

• Ability to serve a variety of facilities equipment supporting manufacturing, critical business functions and administrative areas.
• 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 all work to assure compliance with plans and specifications. Ensures project documents are complete, current, and stored appropriately.
• Provide reports and presentations on proposed projects and policies.
• 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 SOP, WI, Commissioning, Validation Protocols, Deviations, CAPAs and other cGMP 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.
• Cross-functional collaboration to complete projects and solve problems.
• Strong communication skills and the ability to interact with cross-functional groups at all levels.
• Ability to manage competing priorities and maintain tight timelines
• Listed responsibilities are an essential, but not exhaustive list, of the usual duties associated with the position. Changes to individual responsibilities may occur due to business needs.

Requirements:

• Typically Requires a minimum of 2 years of related experience with a bachelor’s degree or technical schooling; or 1 year and a master’s degree; or equivalent work experience in Industrial Engineering, Mechanical Engineering, Electrical Engineering or HVAC/Controls.
• 1-2 years expereince with Equipment/Facilities Engineering, with design and/or maintenance focus
• Knowledge with Siemens BMS Desigo CC Master Operator, HMI is preferred
• Completed facilities management coursework in a technical or trade school, such as HVAC or plumbing, active industry facilities management association members is preferred
• 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/Controls, Boilers, pumps, cooling towers, chillers 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 is preferred
• Must be well-versed with Microsoft Office products such as Word, Excel, and Outlook Must be able to read construction drawings and blueprints
• Familiar with AutoCAD, Revit, and Bluebeam
• Familiar with CMMS, like SAP/EAM, Maximo,