Quality Engineer CSV
Duration: 12 months contract role (hybrid working – 2 days home office, 3 days onsite)
Hours: 80% or 100%
Essential: English & German mandatory, previous pharmaceutical or medical device experience, CSV and GMP required.
Imagine your next project shaping manufacturing innovation in a global company at the forefront of healthcare in the beautiful location of Schaffhausen.
Role Overview
We are seeking a passionate QA Quality Engineer / CSV who will be responsible for the lifecycle management of computerized systems in the manufacturing area, ensure data integrity, and maintain compliance with CSV and governance standards.
Key Responsibilities
* Manage lifecycle of computerized systems in the manufacturing area.
* Ensure GMP and regulatory compliance for qualification activities.
* Review and approve qualification documents (Impact & Risk Assessments, URS, interface qualification, Audit Trail review) and related procedures (WIs, SOPs).
* Approach and use KNEAT digital qualification tool.
* Review and approve requirements for new software solutions, analyze data and process flows.
* Define and approve security, backup, and recovery strategies for production systems.
* Approve archiving or migration of legacy system data as part of lifecycle management.
* Investigate and assess data integrity issues and software non‑conformities (NC, CAPA).
* Support and coordinate cross‑functional teams (Production, IT, Quality Assurance) to integrate production systems and data workflows.
* Ensure structured communication on requirements, system changes, and troubleshooting.
Required Qualifications
* M.Sc. in Natural Sciences, Computer Science, Engineering, or related field (or equivalent experience).
* Proven work experience in GMP‑regulated environments (preferably Quality Control).
* Strong analytical and problem‑solving skills.
* Experience with CSV qualification approach (ISPE standard).
* Fluent in German; basic spoken English skills (B1 or above desirable).
Preferred Skills & Technologies
* Hands‑on familiarity with manufacturing systems qualification, CSV, SCADA, or virtualization.
* Experience with MES, OSI‑PI, SAP, TrackWise, or TruVault.
* Ability to convey technical material to non‑specialists.
Benefits
* Collaborative, inclusive work environment that values work‑life balance.
* Competitive hourly rate.
Equal Opportunity Statement
Johnson & Johnson is committed to creating an inclusive environment where diverse backgrounds, perspectives, and experiences are valued, and each individual feels they belong and can reach their potential.
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