Facilities Engineer

Posting Date 4 weeks ago(9/29/2021 5:04 PM)
Requisition ID
Job Location(s)
Pittsburgh PA United States
Position Type
Full Time
Cook Myosite Inc.


Cook MyoSite, Inc. is on a mission to make regenerative medicine a part of everyday medicine. We’re investigating our core technology, autologous muscle-derived cells, for the potential treatment of several muscle-related disorders. We at Cook MyoSite have the potential to make a difference in the lives of countless people around the world, and we also have the potential to make a difference in yours. Joining our team is an opportunity to ignite your passion, grow your potential, and define your purpose. If you’re curious, motivated by helping others, and driven by integrity, we invite you to apply.


The Facilities Engineer position at Cook MyoSite is responsible for executing departmental functions to support new and ongoing design, operation, and development initiatives in the support and manufacture of Cook Myosite’s products.


• Lead the design of facilities and facility equipment to deliver regulatory body compliant production space
• Works with department management to execute projects and establish timelines to achieve departmental goals
• Maintains open communication with other departments and team members for realization of project and department goals
• Utilization of systems to ensure formality of change management process is consistent with stage of development
• Utilization of systems to ensure appropriate use of quality risk management system in the design and evaluation process
• Utilization of systems to assure design and quality objectives of projects and initiatives are defined prospectively and subsequently met prior to implementation
• Ensures that relevant stakeholders and SME’s are involved at the appropriate stages of project execution and completion
• Ensures the quality and proper management of transfer of new technology and processes
• Oversees daily facility functions, including day-to-day operations, troubleshooting, operation, maintenance, continuous improvement, and functionality of a building management system
• Support GMP process utilities and develop expertise in the following areas: purified water, clean steam generation, air handling units (AHU), building management systems (BMS), plant steam, heating hot water, clean compressed air, chilled water, cooling towers, sanitary sewers, process sewers, and storm sewers, electrical distribution and/or backup systems
• Lead projects involving the design, implementation, and commissioning for new processing equipment and modifications to existing equipment
• Work with industry experts/consultants as necessary to create design specifications, P&ID drawings, GA drawings, User Requirements, Functional Specifications and automation control strategies
• Support investigations of manufacturing deviations related to facility systems
• Where needed, develops additional scientific and technical expertise and capabilities as necessary for project management and completion
• Ensures accuracy and integrity of scientific work performed within department
• Work with industry experts/consultants as necessary to create design specifications, P&ID drawings, GA drawings, User Requirements, Functional Specifications and automation control strategies.
• Develop strategic plans for plant improvements in order to increase cost efficiency
• Enroll facility/utility systems in a computerized maintenance management system (CMMS), with the ability to generate and route work orders from initiation to completion.
• Ensure that preventive maintenance and calibration procedures are in place
• Conduct and perform investigations, CAPAs related to facility/utility, lead change control activities for facility/utility systems
• Prepare commissioning documents and execute facility/utility systems with internal staff or outside contractors.
• Perform design review/design qualification for facility and utility system as required
• Develop user requirement specifications (URS) for facility and utility systems, and changes to URS documents
• Management of final site drawings to ensure that as built and installed facility, utility systems, and facility equipment are maintained and controlled through design review and revision management.
• Ensure designs and modifications meet requirements of local municipality, state, fire, and building codes
• Design and ensure that facility modifications are developed in line with contractual specifications with engineering, area management, and quality.


• Undergraduate degree in Engineering or Engineering Technology field or related technical or quality discipline equivalent professional experience
• Minimum of 1 years' experience in Facilities Engineering and Facilities Design is preferred

• Knowledge of industry standards and guidelines, such as, ASME BPE, ISPE Baseline Guides and CFR’s is preferred.
• Previous experience with piping and instrumentation drawings, preferably in the pharmaceutical industry is preferred.
• Mechanical aptitude with the ability to complete basic mathematical calculations is preferred.
• Familiarity with CAD equipment and software is preferred.

• Proficient knowledge of Microsoft Office software, and other general office equipment.
• In-depth understanding of cGMP, 21 CFR Part 11, and related regulations associated with Bio/Pharmaceutical manufacturing and best practices (e.g. ISPE GAMP)

• Basic understanding of cGMP and engineering systems is preferred
• Knowledge of industry standards and guidelines, such as, ASME BPE, ISPE Baseline Guides and CFR’s is preferred

• Ability and desire to acquire knowledge in related area(s) of department function and development
• Demonstrated self-confidence, and ability to manage consultants, and contractors, while interfacing with multiple departments, working with internal engineers to manage projects, policy and procedures
• Ability to effectively collaborate and communicate with other departments/groups
• Willingness and capability to handle multiple projects and responsibilities
• Must have effective technical writing and communication skills
• Excellent problem-solving skills and ability to work in collaborative and independent work situations and environments with minimal supervision


Physical Requirements:

• Maintenance Setting (EQ, FA, Safety, Warehouse, MC): General office, warehouse and laboratory setting with potential (limited) exposure to hazardous chemicals and/or harsh disinfectants while in BioSafety Level II.

• Must be able to sit at desk, in meetings, and work on a computer
• Physically capable of standing, stooping, kneeling, climbing, reaching, twisting, and bending
• Must be able to work extended hours beyond normal work schedule to include, but not limited to, evenings, weekends, extended work hours and/or extra work hours, sometimes on short notice as required

• Must be able to spend durations in equipment, mechanical, and electrical rooms
• Ability to work under specific time constraints
• Laboratory, warehouse, and office setting


Sorry the Share function is not working properly at this moment. Please refresh the page and try again later.
Share on your newsfeed