Senior LIMS System Engineer

Posting Date 4 months ago(6/21/2021 10:16 AM)
Requisition ID
2021-9179
Job Location(s)
Pittsburgh PA United States
Travel
None
Position Type
Full Time
Company
Cook Myosite Inc.
Category
Information Technology

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), and software development subject matter expertise, the Senior LIMS System Engineer at Cook MyoSite is responsible for the architectural design, software development, integration, and data integrity of LIMS and LIMS related application systems.

Responsibilities

• Define technology solutions based on user/client needs, cost, data integrity needs, and required integration
• As SME for Laboratory Information Systems (LIMS), instrumentation systems, and/or environmental systems, author:
   o Application functional specifications
   o Design and integration documents
• Drive the delivery of features for the MYO LIMS, instrumentation systems, and/or LIMS related application systems by:
   o Configuration of parameters and workflows to define COTS application behavior
   o Programming (i.e. LIMS Basic, SQL, Python, etc.) to extend the capabilities of a COTS application
• Lead application demonstrations to ensure that end-user requirements are met
• Develop software unit tests as part of commissioning LIMS and/or LIMS related applications
• Create and review Standard Operating Procedures (SOPs) and training materials
• Must maintain company quality and safety standards
• Practice and stay 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
• Maintain professional and technical knowledge by attending educational workshops; reviewing professional publications; establishing personal networks; benchmarking state-of-the-art practices; participating in professional societies

Qualifications

• Bachelor’s degree in Engineering or Life Sciences
• Prefer Master’s degree in Computer Science, Information Systems, or Engineering
• 7+ years of relevant industry experience to role
• Demonstrable knowledge of application architecture
• Current advanced LIMS administration certification
• Developed functionality for LIMS instrument integration
• 7+ years of software application experience in:
   o LIMS including Electronic Laboratory Notebook (ELN) worksheets
   o Programming (i.e. LIMS Basic, SQL, Python, etc.)
• Ability to comprehend technical information related to biotech equipment, computer and network hardware, and the associated regulatory expectations; ability to use that information to provide innovative integration solutions
• In-depth understanding of cGMP, 21 CFR Part 11, and related regulations associated with Bio/Pharmaceutical manufacturing and best practices (e.g. ISPE GAMP)

• Ability to demonstrate excellent interpersonal skills, including conflict resolution and drive for results
• Ability to demonstrate excellent communication skills, both written and verbal

 

Physical Requirements:

• General office or laboratory area setting
• Must be able to position at desk, in meetings, and/or work on a computer for extended periods of time
• Ability to conduct ordinary conversation and use virtual workplace (i.e. WebEx, Go to Meeting, etc.) tools
• 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 physically manipulate computers and laboratory or manufacturing equipment including wiring and cables

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