QCA System Engineer I, Computer System Applications

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.

Incorporating life sciences subject matter expertise (SME), the QCA System Engineer at Cook MyoSite, Inc. is responsible for the operational ownership of application systems that provide quality control automation and data analysis (i.e. LIMS, instrumentation systems, etc.).

Responsibilities

• Serve as platform owner for applications for the duration of a Systems Development Lifecycle (SDLC), having responsibility for the delivery, integration, modification, maintenance, and retirement of the application • As a life sciences SME, for Laboratory Information Systems (LIMS), instrumentation systems, and/or environmental systems, authors application functional specifications, configuration and data mapping documents, commissioning documents (i.e. unit tests, software verification tests) • Support the delivery of LIMS, instrumentation systems, and/or environmental systems by either configuration of parameters and workflows to define COTS application behavior or programming (i.e. LIMS Basic, SQL, Python, etc.) to extend the capabilities of a COTS application • Lead application demonstrations and works with end-users and departmental system owners to ensure requirements are met • Actively participate in validation risk assessments and various review meetings supporting application delivery • Execute commissioning; support validation team’s installation qualification (IQ), operational qualification (OQ), and performance qualification (PQ) activities • Functions as an application level system administrator • Create and review Standard Operating Procedures (SOPs) and training materials; conduct training for SOPs • Develop reporting tools to support quality, including configuration to support data trending and analysis • Ensure data integrity of existing systems by monitoring system performance and data metrics • Practice and stays current with ISPE GAMP best practices, FDA GxP regulations, and applicable ISO standards • Coordinate activities with external consultants • Monitor project progress by tracking activities; resolving problems; publishing progress reports; recommending actions

Qualifications

• Undergraduate degree in Bio-engineering, Engineering or any Life Sciences, or 6 years direct, relevant experience in developing, deploying and troubleshooting systems (e.g, LIMS, Enterprise Asset Management, instrumentation and/or environmental systems) to provide a comparable background

• Minimum of 1-3 years' experience in software application experience in one of the following: LIMS including Electronic Laboratory Notebook (ELN) worksheets, Clinical research or trials including analytics, or Automated process monitoring/control systems • Minimum of 1-3 years’ experience in automated data management by either of data aggregation (SQL, MATLAB, etc.) or data transforms (Informatica, SQL Server Integration Services, etc.)

• Knowledge to enhance and debug vendor provided (LIMS Basic, Python, etc.) software solutions • Knowledge in writing Structured Query Language (SQL)

• Proficient knowledge of Microsoft Office software, and other general office equipment. • Basic understanding of cGMP, 21 CFR Part 11, and related regulations associated with Bio/Pharmaceutical product manufacturing • Ability to learn and support new systems and applications, and the ability to provide technical training to end users.

Physical Requirements:

• Hybrid role

• Job Location: Pittsburgh, PA

• Travel: Less than 10%

• 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.