Computer Systems Validation Engineer (2005649)

? Implements Perrigo?s overall computer validation strategy and policy. Ensues that all computer systems used for drug product manufacturing, holding, distribution, testing, and labeling are validated and remain in a state of control.
? Interprets and applies regulations, guidance documents, and industry standards pertaining to the use, validation, and maintenance of computer systems, automated processes, and electronic records.
? Assists Information Services and business areas in developing SOPs pertinent to computer validation
? Works with Information Services and business areas in defining computer validation policies
? Assists in the development of business requirements and system specifications that are complete, specific, verifiable, and non-ambiguous
? Coordinates computer validation projects, ensuring internal SOPs and regulatory requirements are addressed.
? Develop validation plans that include specific project deliverables
? Write/execute/review/approve protocols, reports and other associated documents of the validation process
? Write tests that effectively challenge the operation of computer system software as it will be used at Perrigo
? Guide users in developing relevant risk assessments and remediation options for protocol and system deviations

Required Skills:

? Strong analytical skills
? Excellent oral and written communication skills
? High computer literacy including Microsoft Office products ? Word, Excel, PowerPoint
? Demonstrated ability to organize multiple tasks and to change priorities to meet project deadlines
? High level of technical computer skills including PCs/workstations, hardware and software for networks, application systems, ERP systems, Quality Control lab systems
? Skilled in the understanding, interpretation, and application of FDA regulations and cGMPs to computer systems

Experience Required:

? Bachelor?s degree in a science or technology field such as Computer Science, Electrical Engineering, Chemical Engineering, or Information Systems. Masters degree is preferred but not required.
? Three to five years experience in:
o Computer software and hardware testing and documentation in an FDA regulated industry
o Computer system validation to comply with FDA regulations, cGMPs, and 21 CFR Part 11 ? Electronic Records and Electronic Signatures
o The development, review, and monitoring of computer system SOPs within a Quality Control and Manufacturing environment
? Demonstrated knowledge and experience in:
o Client/server technology
o Database and software design methodologies
o Computer infrastructures
o SAP R/3
o Lab Systems including LIMS
o Programmable Logic Controllers (PLCs)

Please apply at our website:

http://hostedjobs.openhire.com/epostings/jobs/submit.cfm?fuseaction=dspjob&jobid=136011&company_id=15620&version=1&jobboardid=24