Remote Testing Engineer – Analytical & Regulatory Lead

K-Recruiting GmbH; Schweiz; Hybrid; CHF 90,000 - 120,000; Full time

Job summary

K-Recruiting GmbH is seeking a Testing Engineer (M/F/D) to act as the single point of contact for analytical activities within pharmaceutical device projects in Basel, Switzerland. You will create project-specific analytical methods, select laboratories, and lead outsourced analytics while coordinating with cross-functional teams.

Proficiency in statistical analysis (e.g., Minitab) and excellent communication are essential.

Qualifications

• Expert on ISO norms, European Pharmacopeia (Ph. Eur.) and United States Pharmacopeia (USP), their interpretation and application.
• Expert on analytical mechanical methods and their application
• Excellent coordination and communication skills with cross functional device project-team members as well as on drug product level In-depth knowledge of statistical data analysis, strong practical skills in statistical software (e.g. Minitab)
• Highly motivated and able to handle high workload consistently delivering very high quality.
• Specific requirements: English-speaking (excellent verbal and written), access to NRV, GLIMS, 1-QEM (Novartis internal systems) preferable, European working hour preferred (for alignment on working packages and status)

Responsibilities

• Act as Single point of contact for analytical activities within the project for device related testing activities.
• Creation of project specific analytical methods including transfer to internal and external laboratories.
• Selection testing laboratory in-line with resource availability, capability and in/outsource strategy for both projects.
• Leading outsourced analytical project activities at external laboratory and contribution of management external partnership for both independent projects.
• Contribution and review regulatory documents and support project registration activities including presentation at inspections for both independent
• In-depth knowledge of statistical data analysis, strong practical skills in statistical software (e.g. Minitab)
• Oversee and lead all analytical activities of assigned projects; meet customer needs

Skills

Statistical data analysis

Minitab

Analytical methods

Coordination

Communication

Tools

NRV

GLIMS

1-QEM

Job description

K-Recruiting GmbH is seeking a Testing Engineer (M/F/D) to act as the single point of contact for analytical activities within pharmaceutical device projects in Basel, Switzerland. You will create project-specific analytical methods, select laboratories, and lead outsourced analytics while coordinating with cross-functional teams.

Proficiency in statistical analysis (e.g., Minitab) and excellent communication are essential.