GMP Data & Validation Support Engineer

Proclinical Staffing; Bern; Vor Ort; CHF 90.000 - 120.000; Vollzeit

Zusammenfassung

Proclinical Staffing in Bern, Switzerland, seeks a detail-oriented data management specialist to support the Manufacturing Science & Technology (MST) and Validation teams. You will contribute to data management, documentation, and regulatory compliance to ensure efficient operations on critical projects.

The role requires a degree in a scientific field and familiarity with GMP; you will work with systems like LIMS, MES, and STATISTICA to maintain data integrity and support validation activities.

Qualifikationen

• Degree in pharmacy, pharmaceutical technology, biology, chemistry, or related field (Bachelor/Master/PhD) or equivalent industry experience.
• GMP familiarity preferred.
• Strong organizational skills and attention to detail.
• Ability to manage and analyze data effectively.
• Proficiency in maintaining and updating technical documentation.
• Proactive approach to identifying and addressing safety risks.

Aufgaben

• Ensure compliance with safety guidelines and regulations, including proper use of safety equipment.
• Set up, maintain, and validate STATISTICA workspaces for automated data evaluation from LIMS and MES, ensuring data integrity.
• Assist with document archiving, including preparation, organization, and transfer of documentation to the Scan Competence Center.
• Support Validation and MST projects by performing data extraction, processing, analysis, reporting, and sample handling activities.
• Update and maintain SOPs, work instructions, forms, and other controlled documents within the MST and Validation departments.

Kenntnisse

Data management

Data analysis

Documentation

Attention to detail

GMP awareness

Ausbildung

Pharmacy or related scientific field

Tools

STATISTICA

LIMS

MES

Jobbeschreibung

Proclinical Staffing in Bern, Switzerland, seeks a detail-oriented data management specialist to support the Manufacturing Science & Technology (MST) and Validation teams. You will contribute to data management, documentation, and regulatory compliance to ensure efficient operations on critical projects.

The role requires a degree in a scientific field and familiarity with GMP; you will work with systems like LIMS, MES, and STATISTICA to maintain data integrity and support validation activities.