Process Vaildation Specialist--Computer

Job Title:Process Validation Specialist/Computer
Job Purpose:
Provide specialized knowledge in computer and control system validation, computer and quality control system validation for pharmaceutical and medical device manufacturing processes and related products; provide Facility, Equipment and Process Qualification technical expertise.Author validation documents and execute validation of equipment control systems and computer systems.
Essential Functions:
Interface effectively with Management personnel in IT, Engineering, Manufacturing, Regulatory Affairs and other technical disciplines.Provide technical decision making for management and high level technical personnel regarding validation strategies for projects.Prepare and present technical investigative reports to management. Formulate recommendations for disposition or other actions related to investigations associated with equipment and system qualifications.Design and implement Quality Control and Validation systems for new and existing manufacturing processes and products.Design and implement Validation Plans for new and existing manufacturing processes, laboratory system, and IT systems.Manage validation projects by developing protocols.Represent Company in contacts with regulatory agencies, including interface with FDA inspectors and presentations to FDAmanagement personnel.





REQUIRED:BS degree in Computer Science, technical or scientific discipline2 years experience in Equipment, Facility and Process Qualifications (or equivalent) & Medical Device Validation3 + years in general programming to include Visual Basic, SQL1+ years experience in Systems Analysis Experience in requirements definitionDESIRED:Some experience in Computer System ValidationKNOWLEDGE:Industrial Quality Control, Quality Assurance and ValidationMastery of Regulations and their application to Medical Devices and Pharmaceuticals for equipment, facility and process qualifications.Software packages supporting statistical data analysis, word processing and project managementFamiliarity and understanding of manufacturing methods related to the production of medical device productsFamiliarity and understanding of technical disciplines related to Quality Control, including Engineering and Sterilization AssuranceSKILLS:Use of computers and peripherals related to ValidationABILITIES:Ability to work independently and as a team member.Communications skills, both verbal and written commensurate with interfaces at the management levelAbility to work with consultants to work to schedules and tasks within the specialty areaAbility to analyze, investigate and propose approaches to technical and regulatory issuesAbility to design, execute and analysis the manufacturing process validation studiesAbility to execute the Validation Master Plans for medical device and pharmaceutical product manufacturing equipment and facilities Special Requirements.Travel both domestic and InternationalALL RESUMES REMAIN CONFIDENTIAL. Qualified candidates, please send WORD resume, cover letter highlighting strengths for the position and daytime phone number to:Amanda Troy