Computerized System Validation Specialist

PerkinElmer; Canton (OH); On-site; USD 111,000 - 160,000; Full time

Job summary

PerkinElmer is seeking a Computerized System Validation Specialist to support on-site activities at the Schachen site. You will review validated systems, manage CAPA, deviations, and changes, and collaborate with QA and IT to optimize the CSV program across equipment and information management systems.

Ideal candidates have strong knowledge of FDA, GxP, GDP/GLP, and SDLC, plus experience authoring validation documents. German language skills are a plus; English is required.

Qualifications

• Knowledge of FDA regulations and validation standards.
• Experience authoring/reviewing validation documentation.
• Understanding of CGMP and validation practices.
• Familiarity with FDA/ICH guidelines and GDP/GLP concepts.
• Experience in SDLC and cross-functional team collaboration.
• Knowledge of Kneat eVal is a plus.

Responsibilities

• Perform periodic reviews of validated systems documentation.
• Lead or contribute to CAPA, deviations, and change management.
• Collaborate with Lifecycle, IT, and QA to harmonize specs.
• Participate in new system validation projects and investigations.

Skills

FDA regulations

cGMP & validation

GCP, GVP, GMP, GDP, GLP

Validation documentation

SDLC

Kneat eVal

Customer service mindset

Attention to detail

English & German communication

Teamwork & independence

Multi-project management

Education

null

Tools

Kneat eVal

Job description

Computerized System Validation Specialist

Schachen Switzerland

Location Schachen, Lucerne CH

Job ID REQ-058066

We're looking for a Computerized System Validation Specialist to join our team on the Customer site, in Schachen.

The CSV Specialist performs the periodic review of validated systems documentation, to grant systems continue to operate in a validated state, considering device life cycle and applicable norms evolution.

Executes Decommissioning process, acting as document owner for Decommissioning Check List (DCL).
Works with Customer Technology Lifecycle Excellence, 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.
Contribute with Customer QA and Technical Unit in harmonizing and implementing specifications. Contribute in change management and deviation tracking processes, including leading or contributing to CAPA. May contribute to developing procedures and/or protocols.

More information about our OneSource services: OneSource Laboratory Solutions | PerkinElmer

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.

Preferred Characteristics

• 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 (strongly preferred). 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.

Join our Team!

We are strongly committed to the development of your career and giving you opportunities to learn and grow.

We make a difference for you while you make a difference in the world!

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.

Equal Opportunity

PerkinElmer is proud to be an equal opportunity workplace and is an affirmative action employer. PerkinElmer is committed to equal employment opportunity without regard to unlawful considerations of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, gender identity, gender expression, status as a protected veteran, genetic information, or any other personal attribute or characteristics protected by applicable local, state or federal laws.

To learn more about equal employment opportunity protections, please view the available EEO is the Law, EEO is the Law Supplement, and Pay Transparency Non-Discrimination Provision documents.

Please note that PerkinElmer is an E-Verify Employer in the United States. Additional information about E-Verify can be reviewed here.

Accessibility

PerkinElmer is committed to providing reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law. If you have a disability and need assistance with any part of the hiring process or have questions about our workplace accessibility, please email us at [e-mail].