Computer Systems Validation Engineer

The selected candidate will assimilate the global validation strategy and provides guidance to support several local sites to implement and validate Computerized Systems. The Engineer will utilize the solid knowledge of the CGXPs and some background in either manufacturing or quality control as well as project management experience. Candidates will facilitate communication between the Corporate Computer Validation Manager and all company sites. Key responsibilities will include: preparation of documentation for each computer validation study in a timely manner (which on approval will ensure a robust system consistently meeting all acceptance criteria and conforming to the user's requirements), project management of computerized system implementations in particular small to medium system projects, execution of computer validation studies (in accordance with the CGXPs, regulatory requirements, validation master plans, procedures, and protocols), evaluate proposed changes to validated computer systems and execute project management of any re-validation activities. Other aspects to consider: integration in a team of Corporate Validation Engineers, supervision of the activities of multiple contracted employees (taking full responsibility for the quality, timeliness, and completeness of any work completed). This assignment includes some ad hoc project work as well as travel (about one week every other month).

We expect strong experience with the Validation Lifecycle for Computerized Systems including creation of specifications as well as qualification protocols and traceability matrices. Development of validation strategies and Validation Master Plans will be a plus. Strong familiarity with the cGxPs as well as 21 CFR part 11 are required. Familiarity with the concept of risk based validation as well as excellent project management skills will be keys to success in this position. Exposure to manufacturing of FDA regulated products as well as Quality Control and/or Quality Assurance experience is required. Candidates must have strong oral, written, and interpersonal skills as well as proficiency in the use of MS Word and practical application of MS Excel spreadsheets. Candidates must possess good time management and organizational skills and knowledge of FDA and EU regulations and standard validation practices. Candidates must possess a BS/BA in Computer Information Sciences or related fields with a minimum 4 years of experience working with validation in the pharmaceutical/biotechnology industry. Experience with the use of Mercury Tools for software and system testing is required. Experience with the following are also required: computer validation, qualification testing, IQ/OQ/PQ, 21 CFR part 11, URS, FRS, DCS, GAMP 4, Mercury, Test Director, Quick Test Pro.