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 Computer System Validation Manager at Cook MyoSite, Inc. manages validation staffing and task execution for the validation of computer system applications, IT infrastructure, and computer system hardware. The Computer System Validation Manager works with management, especially the Computer System Applications, Information Technology, and Quality Assurance departments, to establish the philosophy for validation approaches to computer systems and IT infrastructure. The information technology manager will work with Information Services management to establish the strategic direction for the department including establishing departmental independence for assessments.
• Manage a team of professionals (computer software validation specialists, computer software validation engineers, data governance analysts, etc.) to drive validation activities for computer systems and IT infrastructure. Lead budgeting and planning for outsourced qualification and validation activities for computer systems and IT infrastructure.
• Ensure change controls and validation tasks are being completed on time and meet the expected quality standards.
• Review computer system and IT infrastructure qualification and validation activities (e.g. VPPs, RAs, IQs, OQs, PQs, VSs, etc.) as needed.
• Work with Quality Assurance to ensure alignment for an agreed upon state of control for computer systems and IT infrastructure including data integrity controls.
• Develop, or lead development of, IT Change Management and Validation Summary Reports.
• 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 computer system validation to provide a comparable background.
• Minimum of 6+ years' experience in IT (Computer Systems) validation including a Master of Science degree in Computer Science or any related field or 9+ years direct, relevant experience
• Minimum of 1-3 years' experience in managing staff for validation or testing for at least one of application delivery, software development, or IT infrastructure deployment.
• Minimum of 3-6 years’ experience in a Biotech/ Pharmaceutical/Med product manufacturing industry regulated by the FDA.
• Minimum of 3-6 years’ experience in System Development Life Cycle (SDLC)
• Ability to demonstrate knowledge of 21 CFR parts 11, 210, 211, 600, 610, and 1271 along with associated best practices (e.g. ISPE GAMP) for CSV qualifications.
• 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 knowledge of domestic and international (e.g. FDA, Health Canada, MHRA, EMA) regulatory requirements and guidelines, including 21 CFR Part 11 and Annex 11.
• Demonstratable working knowledge of corporate Quality Management Systems, current Good Manufacturing Practices (cGMP), and Good Clinical Practice (GCP).
• Advanced proficiency in MS Office, specifically, advanced knowledge of Project, Adobe, OneNote, Excel, Word and PowerPoint; Expert in Outlook.
• In-d• epth understanding of cGMP, 21 CFR Part 11, and related regulations associated with Bio/Pharmaceutical manufacturing and best practices (e.g. ISPE GAMP).
• 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.