Cook MyoSite Incorporated, a division of Cook Incorporated, is a growing, forward-thinking biotechnology organization seeking a full time Systems Analyst. In the role of Systems Analyst, the Applications team member in this position will be responsible for driving IT related activities for various MyoSite Computer Systems that interface with site manufacturing and laboratory equipment. Examples of the Computer Systems are: ThermoFisher Smart-Vue, Siemens APOGEE (BMS), BlueMountain (CMMS), Rees Scientific Centron, etc. To accomplish this, we are seeking a detail oriented individual whom is excited and capable to engage with our business, facility, and validation teams to deliver innovative and technical solutions.
Work with Business Analysts to:
Document business or process needs
Define technical project scope and objectives
For new systems or updates to existing systems author:
Application functional specifications
Application configuration documents
Application installation and operational verification documents
Independently develop applications and solutions by configuration of application parameters and workflows to define the behavior of a COTS (e.g. commercial vendor) system
Integrate equipment into Computer System Applications; equipment such as Smart-Vue Sensors, Cytometers, UVO cleaners, Monitoring Instruments, Air Handlers, etc.
Function as an application level system administrator
Ensure data integrity of existing systems by monitoring system performance and data metrics
Coordinate with external consultants
Maintain system protocols (SOPs) by writing and updating procedures
Perform day-to-day activities driven by SOPs
Must maintain company quality and safety standards
A Bachelor’s degree in Computer Science, Engineering, Information Systems, or a technology based related field of study
3 - 6 years of experience with described applications with your role being one of:
Applications Engineering / Configuration
Equipment / Facilities Engineering using automated systems
Experience with systems development lifecycle
Excellent interpersonal and communication skills, both written and verbal
Excellent problem solving skills and ability to work in collaborative and independent work situations and environments without supervision
Understanding of cGMP, 21 CFR Part 11, and related regulations associated with Bio/Pharmaceutical/Med product manufacturing and best practices (e.g. ISPE GAMP)
• Must be able to physically position at desk, in meetings, and work on a computer in an office setting for long or extended periods of time
• Physically capable of standing, walking, stooping, kneeling, climbing, reaching, twisting and bending on occasion with or without reasonable accommodation in a warehouse or laboratory setting
• Must perform PPE procedures including, safety glasses, lab coat, gloves, and appropriate shoes on occasion • Must be able to at times work extended hours beyond normal work schedule to include, but not limited to, evenings, weekends, extended work hours, sometimes on short notice as required • Ability to work under specific time constraints
Employer will assist with relocation costs.
About Cook MyoSite, Inc.
Cook MyoSite® is a leader in the regenerative medicine industry by advancing our own personalized investigational cell therapy products toward the market through extensive clinical trial experience. Cook MyoSite’s mission is to advance the science of personalized regenerative medicine to elevate cellular therapies to an accepted and accessible option beyond traditional care. Cook MyoSite creates specialized treatments for patients. These treatments use the patient’s own muscle cells in a unique procedure that begins and ends with the patient’s own body. Currently, this technology is being investigated in clinical trials and is not commercially available.