Job Description

Overview

Cook MyoSite, Inc., part of the Cook Group, Inc. family of companies, 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 Quality Control Automation (QCA) System Engineer I at Cook MyoSite, Inc. is responsible for the lifecycle ownership of application systems that provide quality control automation and data analysis such as:• Facility environmental management systems (i.e., Building Automation Systems or Building Management Systems such as Siemens Desigo CC or Schneider Electric EcoStruxure)• Environmental equipment management systems (i.e., temperature in monitoring in cryogenic areas (like freezers), pressure and oxygen/CO2/H2O2 monitoring systems such as Rees Scientific Centron Presidio or Beckman Coulter UVO)• Calibration management systems (i.e., providing calibration tracking and change management for assets requiring calibration such as the Blue Mountain Regulatory Asset Management system)

Responsibilities

• Serve as an application platform owner having responsibility for actively participating in the installation, integration, modification, maintenance, and retirement of an application.• As an application platform owner, function as an application level administrator.• As an application platform owner, contributes in a support capacity internally and with vendors.• Adhere to Standard Operating Procedures (SOPs) and documentation requirements while authoring requirement specifications, functional specifications, configuration specifications, and various testing (i.e., plan, scenarios, cases) documents.• Support the delivery of application features and workflows by the configuration of parameters and templates to define COTS application behavior, along with developing reports.• Execute system, integration, and user acceptance testing; support validation team’s installation qualification (IQ), operational qualification (OQ), and performance qualification (PQ) activities.• Supports application demonstrations and works with end-users and departmental system owners to ensure requirements are met. • Provide 2nd level of support for applications used in manufacturing and laboratory operations as needed, including off-hours.

Qualifications

• Undergraduate degree in Computer Science, Information Science, Engineering, or 6+ years’ experience in the above listed responsibilities.• Prefer 2+ years' experience with scripting such as PowerShell or some programming language.• Prefer 2+ years' in writing Structured Query Language (SQL).• Ability to work in collaborative and independent work situations and environments with minimal supervision.• Demonstratable effective verbal, written and interpersonal skills.• Demonstratable ability of critical thinking and proven problem-solving skills.• This position requires an ongoing commitment to upgrading knowledge, job skills and abilities in addition to competency related to all duties and responsibilities listed above.• This position requires an ongoing commitment to exemplify Cook MyoSite Values.

Physical Requirements:

• Setting: Hybrid position - Must have the ability to travel on-site in Pittsburgh, PA at least 3 days per week.• Office Setting - General office, warehouse and laboratory setting with potential (limited) exposure to hazardous chemicals and/or harsh disinfectants while in BioSafety Level II.• Travel - Less than 10%, domestic.• 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.