| 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…Pyramid Consulting Group has a Pittsburgh client with an immediate need for an experienced CSV MANAGER to lead budgeting and planning for outsourced qualification and validation activities for computer systems and IT infrastructure. Other responsibilities include:
* 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.
The client is looking for the following background and skills:
* 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 and 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;
* 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; * Advanced proficiency in MS Office, specifically, advanced knowledge of Project, Adobe, OneNote, Excel, Word and PowerPoint; Expert in Outlook. Please forward your resume directly to [email protected] for immediate consideration. Thank you |
