Computerized System Validation Specialist; m​/f​/d

Overview

When joining Perkin Elmer, you select an experienced and trusted leader in scientific solutions, with the support of a global service network and distribution centers, providing the right solution, at the right time, to meet critical customer needs. With over an 80+ year legacy of advancing science and a mission of innovating for a healthier world, our dedicated team collaborates closely with commercial, government, academic and healthcare customers to deliver our broad portfolio of analytical solutions and services.

• Works with Customer Validation Unit, IT and cross functional departments in development and implementation of an efficient Computerized Systems Validation Program for automated equipment, processes, and information management systems for the Laboratory and Manufacturing Operations.
• Identifies computerized systems validation needs through in-house / external assessments.
• Responsible for the development of Software/Computers validations Protocols and final report as well as to coordinate and perform activities as per approved protocol.
• Works with systems owners to ensure validation is conducted prior to deployment of GxP systems and systems are maintained in a validated state.
• Work closely with IT to meet relevant regulations, such as FDA 21 CFR Part 11 and TGA Annex 11.
• Deviations from or corrective actions for any part of the Computer and Lab Systems Quality System based on written justification and cross functional review of impacted parties.
• Participate as assigned IT Representative or lead project teams to implement and validate computerized or automated Lab Instrumentation / process equipment and associated computer hardware and software.
• Experience with ISPE GAMP Computer System Development Life cycle methodology is a must.
• Knowledge of Client-Server and virtualized (VDI) environment, UNIX, NT, Windows.

• Bachelor's degree in Information Systems, Engineering, Science or similar technical discipline required.
• Minimum 3-5 years of experience working in the Biotech/Pharmaceutical industry in Quality Compliance or Computer System Validation roles.
• Strong background and understanding of FDA regulations.
• Knowledge of Good Clinical practice (GCP), Good pharmacovigilance Practice (GVP), Good Manufacturing Practices (GMP), Good Documentation Practices (GDP), and Good Laboratory Practices (GLP).
• Experience in authoring/reviewing/approving validation documentation.
• Previous experience with Kneat eVal environment would be a plus.
• Working knowledge of software development lifecycle (SDLC).
• Good written and verbal communication skills with ability to work with cross-functional teams in English and German Additional languages would be a plus.
• Experience with vendor audits, quality agreements
• Ability to manage multiple projects

Availability required to travel occasionally across Europe, typically for projects kick-off, mid-project reviews/execution, project completion.