Computer Systems Validation Specialist

You will work with a team within the IT group responsible for installing and maintaining a set of validated computer systems. Your role on this team will be to participate in Computer Validation activities for niche and enterprise computer systems and assuring compliance with the GAMP and 21CFR Part 11 regarding electronic records and signatures and to coordinate computer validation activities to ensure a consistent approach to computerized system validation across all IT departments and sites.Your primary responsibilities will be to participate in projects requiring computer system validation and draft, review and/or consult on the documentation required for a successful launch. This includes master validation plans, protocols, summary reports, IQ, OQ, PQ test scripts, and other documentation related to software validation change requests. You will be a key member on new software project teams, helping to define validation requirements and when appropriate, provide compliance guidance for validation. You will be expected to actively participate on the Project teams during design and planning phases, commissioning and testing phases to ensure that the computer system design and testing is conducted in accordance with all regulatory and end user requirements. You will also work closely with the other members of IT to ensure standardize approach to all validation policies and procedures, templates and documentationThe ideal candidate will also assess gaps in current systems and partner with the Quality organization and with other support groups to develop and implement process improvement. You will also have the opportunity to conduct training on validation procedures, SOP's and system changes for others in MIS. Longer term, we would also like you to represent IT on software related Capital Projects teams. This includes providing IT requirements for User Requirements documents, Risk Assessment, Design Specs, Software Design Description, etc.Qualifications
You must have a BA/BS in Science, Computer or Business, 5 years of related or relevant experience minimum required, preferably in the pharmaceutical or related industry.
You must have a solid understanding of Software Validation (Network, Database systems/programming experience desirable).
You must have a clear understanding of Good Manufacturing Practices and experience in a biotech, medical or pharmaceutical manufacturing environment.
You must have the ability to work effectively with various departmental personnel and clients.
You must be detail oriented, have strong written, verbal and interpersonal communication skills to represent MIS when interacting with other departments, clients and regulatory agencies.
Lastly, you must possess strong investigation and problem solving skills.
REQUIREMENTS
See Above / gj-hh