CSV and IT Compliance EngineerManager
CSV and IT Compliance EngineerManager
Employer Active
Job Alert
You will be updated with latest job alerts via email
Share
Job Alert
You will be updated with latest job alerts via email
Not Disclosed
Salary Not Disclosed
1 Vacancy
Job Description
46 months contractor FRENCH Speaking necessary
Our customer is an innovative biopharmaceutical Big Pharma company. For an on site assignment for the brand new commercial manufacturing site we are looking for 2 experts in CSV for Pharma Industry.
As part of their continuous growth our client is implementing new IT systems at their local manufacturing and packaging units. To support these initiatives we are seeking an experienced CSV and IT Compliance Engineer/Manager.
You have:
- Bachelors degree in Science Engineering or a related discipline.
- 710 years of experience in the pharmaceutical or biotechnology industry including expertise in Quality Management Systems and GxP systems such as MES and SAP.
- Proficiency in Computer System Validation (CSV) Data Integrity requirements and regulatory frameworks (21CFR Part 11 EudraLex MHRA).
- Experience with Six Sigma Lean or Business Process Change techniques is a plus.
- Strong analytical and structured working style with exceptional attention to detail.
- Excellent communication and collaboration skills to work in multidisciplinary international teams.
- Fully operational in both English and French.
- Swiss residency or a valid Swiss work permit is mandatory (crossborder candidates welcome)
Your tasks:
- Ensure compliance with pharmaceutical industry standards and regulations including EUGMP Annex 11 and 21CFR part 11.
- Lead Computer System Validation (CSV) activities for site IT systems and infrastructure.
- Act as the local representative for global IT projects with quality implications such as Digital Modernization initiatives.
- Oversee the qualification of site IT infrastructure in collaboration with global teams.
- Define quality expectations and support the IT department and third parties in implementing GMPcompliant systems.
- Conduct riskbased prioritization of IT activities in support of Quality Assurance.
- Translate compliance requirements into test conditions and acceptance criteria for application functionality (IQ PQ FAT).
- Ensure adherence to design and governance standards while contributing to effective communication with stakeholders.
You will:
- Be part of an innovative dynamic team at a globally recognized biopharmaceutical leader.
- Work on impactful projects that directly support patient outcomes.
- Enjoy a collaborative work environment with opportunities for professional growth.
Employment Type
Full Time
