Computerized System Validation Specialist (m/f/d)
Schachen Switzerland
Responsibilities
Location Schachen, LucerneCH Job ID REQ-053639We are looking for experienced CSV professional to join our OneSource team at the Customer site in Schachen.
Role responsibilities:
Periodic Reviews
Works closely with Lifecycle & Compliance team to perform periodic reviews of validated systems (both equipment and instruments)
Actively contributes to harmonization projects by identifying specification discrepancies across the installed base at Customer site.
Processes Changes, Temporary Changes, Deviations, and CAPA related with periodic review findings.
Computerized Systems Validation
Participate as author or executor to new system validation projects, partnering with Customer CSV team.
Contributes to changes and investigations as a member of cross-functional teams.
Requirements:
Bachelor's degree in Information Systems, Engineering, Science or similar technical discipline or years of experience in similar position.
Minimum 3 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 cGMP and validation regulations and requirements.
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.
Working knowledge of software development lifecycle (SDLC).
Previous experience with Kneat eVal environment would be a plus.
Developed Customer service mindset.
Be passionate in attention to detail and tech aspects.
Strong written and verbal communication skills in English (required), German (would be beneficial). Any additional language would be a plus.
Ability to work both independently and as a team member, within prescribed guidelines, coping with frequent grey areas / uncertainty.
Ability to manage multiple projects.
PerkinElmer is committed to creating a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability status, age, or veteran status or any other characteristics protected by applicable law. PerkinElmer is committed to a culturally diverse workforce.
