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 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.
• Provide evaluations and recommendations for implementing and maintaining automated testing.
• Ensure change controls and validation tasks are being completed on time and meet the expected quality standards.
• Supervise, perform, review, and document 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.
• Practice and stay current with ISPE GAMP best practices, FDA and EU GxP regulations, and applicable ISO standards.
• Maintain professional and technical knowledge by attending educational workshops; reviewing professional publications; participating in professional societies.
• Bachelor’s degree in Engineering, Information Systems, Life Sciences or related technical field; or 10+ years of experience as a manager of computer system validations
• 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 leadership and critical thinking
• Ability to demonstrate technical expertise in planning and execution of validations for computer system applications, computer system infrastructure, and computer system hardware in relation to biopharmaceutical processes
• Ability to demonstrate an understanding of regulations and guidelines governing biological product development in relation to quality requirements for computer system applications, computer system infrastructure, and computer system hardware
• Ability to demonstrate excellent organizational, interpersonal, and communication skills.
• Ability to demonstrate expertise in the understanding of principles for application integration and regulations for data integrity
• In-depth understanding of cGMP and 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
• Demonstrable ability to influence stakeholders and work with them to determine acceptable solutions
• Advanced proficiency in MS Office, specifically, advanced knowledge of Project, Adobe, OneNote, Excel, Word and PowerPoint; Expert in Outlook
• Office Setting / No Travel
• 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.