You manage the CSV framework and Data Integrity training, report concerns to leadership, and ensure compliance with regulations, all while playing a key role in global initiatives.
Anforderungen
- •Degree in Information Technology or Engineering
- •Proven experience in CSV and data integrity
- •Able to lead staff by example
- •Strong understanding of GMP regulations
- •Outstanding skills in training staff
- •Ability to adhere to regulatory requirements
- •Excellent communication and collaboration skills
- •Self-motivated with a track record
Deine Aufgaben
- •Coordinate the Site’s CSV framework and processes.
- •Establish and maintain GMP and Data Integrity training.
- •Participate in Data Integrity Gemba and mentor DI champions.
- •Report Data Integrity concerns to the Site Leadership team.
- •Implement mitigation actions based on the Site Masterplan.
- •Oversee the site KPIs related to Data Integrity.
- •Represent the Lengnau Site in global Data Integrity initiatives.
- •Ensure regulatory compliance with CSV and support submissions.
Original Beschreibung
# CSV & DI Officer
**Lengnau, Switzerland** | **Full time** | **Fully Onsite**
**Work Schedule**
Standard (Mon-Fri)
**Environmental Conditions**
Adherence to all Good Manufacturing Practices (GMP) Safety Standards
**Job Description**
## What Makes This Opportunity Unique
At Thermo Fisher Scientific Inc., Lengnau, we are committed to innovation and excellence. As a CSV & DI officer, you will play a pivotal role in ensuring our computerized systems validation (CSV) framework and processes are innovative. Your work will contribute to a world-class compliance lifecycle approach, improving our site's GMP and Data Integrity standards. This position offers an ambitious individual the chance to lead, train, and mentor staff, while collaborating closely with Execution Systems, Engineering Quality team, supply chain, manufacturing and Quality Control.
## Job Responsibilities
* Coordinate the Site’s CSV framework and processes, ensuring flawless validation activities.
* Establish and maintain the GMP and Data Integrity training.
* Coordinate / participate to the on-the-floor Data Integrity (DI) Gemba and provide mentoring to DI champions.
* Ensure timely reporting of Data Integrity concerns to the Site Leadership team and implement mitigation actions based on the approved Site Masterplan.
* Owner of the DI site KPIs.
* Represent the Lengnau Site in global Data Integrity networks and initiatives.
* Ensure regulatory compliance associated with CSV and contribute to regulatory submissions, responses, and inspections.
## Requirements
* Degree in Information Technology, Engineering or Life Sciences (Biology, Chemistry, etc.), Dipl. lng. or M.Sc. or B.Sc. or equivalent.
* Proven experience in coordinating computerized systems validation (CSV) and data integrity in operations.
* Able to lead staff by example, providing technical support and mentoring.
* Strong understanding of GMP regulations and validation practices.
* Outstanding skills in training and mentoring staff on compliance frameworks.
* Ability to strictly adhere to regulatory requirements and successfully implement necessary actions.
* Excellent communication and collaboration skills to work effectively with cross-functional teams.
* Self-motivated with a track record of contributing to regulatory submissions and inspections.
**Why Join Us?**
Join us in our mission to make the world healthier, cleaner, and safer. At Thermo Fisher Scientific, you will work in an inclusive environment that values diverse experiences and perspectives. Be part of an ambitious team that strives for excellence and innovation every day. This is your opportunity to contribute to groundbreaking scientific advancements and help support patients globally!