Cook - Institution jobs in Greensburg, PA

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.

Incorporating life sciences subject matter expertise (SME), the Quality Control Automation (QCA) System Engineer III at Cook MyoSite, Inc. is responsible for the technical lifecycle and day-to-day up-time of MyoSite enterprise facility environmental management systems, and/or equipment management systems, and/or calibration management systems from the operating system to the Commercial Off-The-Shelf (COTS) applications.

Responsibilities

• Serve as a system platform owner for multiple systems; e.g., responsibility for managing the system lifecycle including feature delivery, integration, modification, and maintenance.• Responsible for working with process owners and system owners to ensure their day-to-day and long term system operational and project related expectations are met.• Function as an application level and system level administrator as needed.• 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. • Adhere to Standard Operating Procedures (SOPs) and documentation requirements while developing and executing formal testing (e.g., commissioning) for systems.• Guide and support the validation team during validation planning and qualification activities for application enhancements and upgrades.• Create and review Standard Operating Procedures (SOPs) and training materials; conduct training for SOPs.• Practice and stays current with ISPE GAMP best practices, FDA GxP regulations, and applicable ISO standards.• Communicate cross-functionally and with external consultants.• Review and/or delegate work to technical professionals as needed.• 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, Life Sciences, or 10 years’ experience in the above listed Responsibilities.• Minimum of 5 years' experience in system administration along with application configuration aligning with the above listed Responsibilities for any of the following types of systems: • 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)• Minimum of 5 years’ of experience in a system and/or application administration role providing value for manufacturing or laboratory operations in Biotech, Pharmaceutical, or Medical Device manufacturing that was regulated by the FDA and subject to 21 CFR Part 11 requirements.• Prefer 2 years' experience using PowerShell or some programming language.• Demonstratable ability to work in collaborative and independent work situations and environments while multitasking.• Demonstratable effective verbal, written and interpersonal skills.• Demonstratable ability to prioritize and operate proactively with minimal need of supervision.

Physical Requirements:• Hybrid position - Must have the ability to travel on-site in Pittsburgh, PA.• Office Setting: General office, warehouse and laboratory 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.