Equipment Engineer

Posting Date 4 weeks ago(9/3/2020 4:40 PM)
Requisition ID
2020-7822
Job Location(s)
Pittsburgh PA United States
Travel
None
Position Type
Full Time
Company
Cook Myosite Inc.
Category
Engineering

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 Equipment Engineer position at Cook MyoSite is responsible for the development and maintenance of the equipment program related to direct impact equipment used within the AMDC manufacturing process, specifically equipment falling under the jurisdiction of Process Engineering.

Responsibilities

• The Equipment Engineer contributes specialized experience to the Cook MyoSite Process Engineering team, with a variety of essential job functions particularly focused on commissioning/decommissioning,  equipment maintenance, equipment calibration, equipment implementation, investigation and quality support, process knowledge and project support 

• Write commissioning/decommissioning protocols and execute commissioning/decommissioning activities
• Develop and maintain procedures and documentation associated with commissioning/decommissioning activities
• Development of procedures and systems in support of equipment maintenance. While maintenance activities are developed by the Equipment Engineer, they are not performed or tracked by Equipment Engineering
• Development of maintenance intervals for equipment used in AMDC manufacturing
• Development of procedures and systems in support of equipment calibration. While calibration activities are developed by the Equipment Engineer, they are not performed or tracked by Equipment Engineering
• Development of calibration intervals for equipment used in AMDC manufacturing 
• Work alongside Process Engineers when new equipment is implemented
• Work with vendors when new equipment is being implemented
• Lead development of user requirements for existing equipment and equipment being implemented
• Document DR/DQ documentation as needed for required equipment and instruments
• Authoring of investigations associated with equipment failures
• Collaboration with vendors through investigations in order to determine root cause of equipment failure
• Act as a resource to provide technical and scientific troubleshooting and other support to company departments, as needed, for CAPAs, investigations, followups to investigations, and implementations
• Write or direct the writing of GMP equipment documentation, including specifications, operating procedures/work instruction, maintenance procedures
• Maintain a high-level understanding of the AMDC manufacturing process in order to provide support during implementation of new equipment and instrument
• Work as the Equipment Engineering representative as part of project work

Qualifications

• Undergraduate degree in Engineering at minimum; Mechanical Engineering preferred 

• 3+ years of experience managing and leading projects or relevant experiences within the biopharmaceutical or healthcare industry
• 3+ years of experience working within an equipment engineering or mechanical engineering role
• Calibration technical certificate is plus
• Knowledge of calibration management in regulated industry (pharmaceuticals, biotechnology)
• Proficiency in MS Office and other general office equipment
• Must maintain a high level of professionalism, business acumen
• Must have effective verbal, written and interpersonal skills
• Maintain composure and competence under stressful situations; flexibility and adaptability
• Ability to work in collaborative and independent work situations and environments with minimal supervision
• Basic understanding of cGMP, 21 CFR Part 11, and related regulations associated with Bio/Pharmaceutical product manufacturing
• Must possess excellent organizational skills and the ability follow complex processes, procedures and systems
• Demonstrate critical thinking and ability to execute goals set by the organization and Department Manager

 

Physical Requirements:

• Lab / Non-Production Setting

• 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 laboratory setting or sitting in biological safety hood setting.

• 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 an occasional basis with or without reasonable accommodations.

• Must be capable of performing PPE gowning procedures on a frequent basis to enter BioSafety Level II including safety glasses, lab coat, gloves, specialized clothing including laboratory scrubs (pants and shirt) and facial mask (if required) on a regular basis.

• Must be able to extend arms outright for extended periods of time, periodically at intervals for up to 3 hours at a time.

 

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