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 Software Validation Engineer at Cook MyoSite is responsible for software validation projects, to ensure that all software and systems validation are complete and develop, author, and complete quality system documentation. Additionally, this position will provide Subject Matter Expertise on software validation projects to pharmaceutical manufacturing, processes and controls.
• Responsible for software validation projects• Ensure that all software and systems validation are complete and in auditable state• Develop Requirement Trace Matrix for the validated system• Develop, author, and complete quality system documentation and develop Standard Operating Procedures for performance of computer system validation• Provide Subject Matter Expertise (SME) on software validation projects to pharmaceutical manufacturing, processes and controls• Ensures that Commercial Off-The-Shelf (COTS), COTS with configurations and in-house developed software/systems validation are complete and in an auditable state• Responsible for authoring and execution of IQ, OQ, PQ and Summary Reports• Responsible for authoring Business and Validation Category Impact Assessment (BVCIA) documentation• Responsible for authoring criticality and risk assessment documentation• Responsible for developing Requirement Trace Matrix for the validated system• Initiates Validation Change Requests for various validation changes to the existing system or new system implementation• Understand and comply with standards including International Society for Pharmaceutical Engineering (ISPE), Parenteral Drug Association (PDA), and United States Pharmacopeia (USP)• Initiate, coordinate and execute projects to ensure the successful completion of CSV• Participate in Validation Department meetings and other company initiatives as required• In-depth knowledge of software design, development, and maintenance and workflow development• Experience in Laboratory Information Management Systems and Electronic Document Management Systems• SME knowledge of corporate Quality Management Systems and current Good Manufacturing Practices• Working knowledge of domestic and international (e.g. FDA, Health Canada, EMA) regulatory requirements and guidelines, (specifically 21 CFR Part 11 and Annex 11) and ISPE methodology (GAMP 5)• Experience working with ERP applications; bio/pharmaceutical automated manufacturing system validation• Development of User Requirement Specs, Functional/Design Specs, Project Plans, Project Charter, Program Plans, Validation Plans, System Analysis/Assessments, Risk Analysis, Requirement Traceability Matrix, IT Change Management, IOQ/PQ Protocols/Reports and Validation Summary Reports• Maintain frequent communication with Information Services staff (CSA, QA, IT) process and system owners, and other support functions
• Bachelor's degree in Computer Science or any related field or 6 years direct, relevant experience in IT (Computer Systems) validation to provide a comparable background
• Minimum of 3-6 years' experience in IT (Computer Systems) validation is preferred
• Minimum of 6 years’ experience in software analysis and developing and executing verification and validation procedures is preferred• Experience with Open Text – Content Server is preferred
• Proficient knowledge of Microsoft Office software, and other general office equipment• In-depth understanding of cGMP, 21 CFR Part 11, and related regulations associated with Bio/Pharmaceutical manufacturing and best practices (e.g. ISPE GAMP)• Up-to-date with changes in technology and the business implications/applications of new technologies• Ability to learn and support new systems and applications, and the ability to provide technical training to end users
• 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• Must be able to sit at desk, in meetings and/or work on a computer; physically capable of standing, stooping, kneeling, climbing, reaching, twisting and bending with or without reasonable accommodation; climbing a mobile ladder and/or other types of ladders on occasion with or without reasonable accommodation• Ability to physically manipulate computers and laboratory or manufacturing equipment including wiring and cables• Physically capable of standing, walking, stooping, kneeling, crouching, climbing steps and ladders, reaching, twisting and bending on occasion with or without reasonable accommodations• Must be able to lift/push/pull up to 50 pounds on a regular basis• Must be capable of performing PPE gowning procedures to enter BioSafety Level II including safety glasses, lab coat, gloves, specialized clothing including laboratory scrubs (pants and shirt) and appropriate shoes required on occasion; potential limited exposure to hazardous chemicals and/or harsh disinfectants while in BioSafety Level II