Facilities Engineer

Posting Date 2 weeks ago(9/14/2020 1:25 PM)
Requisition ID
2020-7874
Job Location(s)
Pittsburgh PA United States
Travel
None
Position Type
Full Time
Company
Cook Myosite Inc.
Category
Facilities/Maintenance

Overview

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.

Responsibilities

• 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.

 

Qualifications

• Undergraduate degree in Engineering or Engineering Technology field or related technical or quality discipline equivalent professional experience
• Minimum of 6+ years' experience in Facilities Engineering and Facilities Design preferred
• In-depth understanding of cGMP, 21 CFR Part 11, and related regulations associated with Bio/Pharmaceutical manufacturing and best practices (e.g. ISPE GAMP) 
• 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
• Mechanical aptitude with the ability to complete basic mathematical calculations
• Familiarity with CAD equipment and software is preferred

• Demonstrated 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

• Proficient knowledge of Microsoft Office software, and other general office equipment.

 

Physical Requirements:

• Maintenance Setting: General office, warehouse and laboratory setting with potential (limited) exposure to hazardous chemicals and/or harsh disinfectants while in BioSafety Level II.
• Ability to conduct and hear ordinary conversation and telephone communication.

• 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.

• Ability to work under specific time constraints.

• Must be able to sit at desk, in meetings and/or work on a computer for long or extended periods of time.

• Visual and manual acuity for working with computers and equipment.

• Ability to spend majority of day standing in warehouse setting for extended periods of time, and at times work within confined areas.

• Physically capable of standing, walking, stooping, kneeling, crouching, climbing steps and ladders, reaching, twisting and bending on occasion with or without reasonable accommodations.

• Must be able to lift/push/pull up to 50 pounds on a regular basis.

• Must be capable of performing PPE gowning procedures on a frequent basis to enter BioSafety Level II including but not limited to safety glasses, lab coat, gloves, specialized clothing including laboratory scrubs (pants and shirt), appropriate shoes, and facial mask (if required) on a regular basis.

 

 

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