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.
The Manager, Computer System Applications - Manufacturing & Operations (CSA-M&O) at Cook MyoSite, Inc. manages staffing and task execution for configuration, testing, and deployment of commercial off the shelf (COTS) computerized system applications. The CSA-M&O Manager works with management, especially the Computer System Validations, Information Technology, and Quality Assurance departments, to establish the philosophy for delivering reliable and efficient computer systems to support the manufacturing and operational aspects of Cook MyoSite.
• Manage a team of professionals (system analysts, system engineers, etc.) to support the development and administration of computer systems for the company’s manufacturing and operations processes.
• Establish best-practices for planning, managing, implementing, and support for systems such as Laboratory Information Management Systems (LIMS), Enterprise Resource Management Systems (ERP), Building Management Systems (BMS), Regulatory Asset Management Systems (RAM), Equipment Management Systems (EMS), etc.
• Support validation of the managed computer systems through qualification lifecycles and audits.
• Provide hardware and software evaluations and recommendations.
• Identify opportunities for automated process improvements.
• Implement change controls, SOPs, policies and procedures.
• Front Line Leadership is primarily tasked with departmental decisions and output on activities related to quality, operations, and the business. They are accountable to Senior Leadership and Directors for their department or functional area and are the technical experts.
• Front Line Leadership functions include managing departmental resources appropriately, assessing performance, providing feedback, and identifying gaps. Front Line Leadership also must be skilled communicators, able to convey clear expectations, listen for feedback, and provide updates in a timely manner.
• Undergraduate degree in Computer Science, Engineering, Information Systems, or related technical field; or 10+ years direct, relevant experience in managing operational delivery of COTS System Development Life Cycles for use manufacturing to provide a comparable background.
• Minimum of 1-3 years' experience in managing staff as direct reports for at least one of application delivery or software development.
• Minimum of 3-6 years’ experience in a Biotech/ Pharmaceutical/Med product manufacturing industry regulated by the FDA.
• Minimum of 3-6 years’ experience with manufacturing systems; Level I, Level II, or Level III. Preferred is experience with LIMS, ERP, BMS, RAM, or EMS.
• Demonstratable in-depth knowledge of regulations such as 21 CFR parts 11, 210, 211, 600, 610, and 1271 related to validation of computerized systems.
• Demonstratable ability to understand and comply with standards and best practices including Parenteral Drug Association (PDA), United States Pharmacopeia (USP), International Conference on Harmonization (ICH), and the International Society for Pharmaceutical Engineering (ISPE) methodology (e.g. GAMP 5).
• Demonstratable advanced proficiency in MS Office, MS SharePoint, and MS Teams.
• Hybrid role
• Travel: Less than 10% - Role requires individual to be on-site weekly.
• Job Location: 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.