Sr. Scientist / Engineer – Equipment Qualification

gloor&lang AG; Neuenburg; Vor Ort; Vertraulich; Vollzeit

Zusammenfassung

A leading pharmaceutical site in French-speaking Switzerland is offering a 6-month temporary contract for a Senior Validation Scientist or Engineer. You will play a crucial role in supporting a major equipment qualification project in a GMP-regulated OSD manufacturing environment, leading the qualification of equipment and ensuring compliance with industry standards. This role requires strong communication skills, significant validation experience, and fluency in French.

Qualifikationen

• Minimum 5 years of experience in validation or qualification within the pharmaceutical industry (GMP environment, OSD experience preferred).
• Fluency in French required, good command of English essential.

Aufgaben

• Lead the commissioning and qualification of production equipment and computerized systems (CSV).
• Define and implement qualification strategies (DQ, FAT, SAT, IQ, OQ, PQ).
• Review and author qualification protocols and reports in alignment with industry and regulatory standards.

Kenntnisse

Communication

Documentation skills

Change management

Project management

Validation practices

Ausbildung

Degree in Engineering or Life Sciences

Jobbeschreibung

Contract till end of year - OSD Manufacturing

Location: French-speaking Switzerland (Romandie)
Duration: 6 months (temporary contract)
Languages: French required, English fluent

A leading pharmaceutical site in French-speaking Switzerland is seeking an experienced Senior Validation Scientist or Engineer to support a major equipment qualification project in an oral solid dosage (OSD) manufacturing environment. This is a temporary assignment within the MS&T team, focusing on revamping a tableting production area in a GMP-regulated setting.

Your Responsibilities:

• Lead the commissioning and qualification of production equipment and computerized systems (CSV)
• Define and implement qualification strategies (DQ, FAT, SAT, IQ, OQ, PQ)
• Collaborate closely with cross-functional teams (Engineering, QA, MS&T, Production, Suppliers)
• Review and author qualification protocols and reports in alignment with industry and regulatory standards
• Ensure execution of qualification activities in accordance with internal standards and budget
• Support audits and inspections as SME for validation documentation
• Initiate and manage change controls, investigations, and CAPAs related to qualification

Your Profile:

• Degree in Engineering or Life Sciences
• Minimum 5 years of experience in validation or qualification within the pharmaceutical industry (GMP environment, OSD experience preferred)
• Solid knowledge of equipment and CSV validation practices
• Hands-on experience in project and change management
• Proactive communicator with strong documentation skills
• Comfortable navigating a cross-functional and dynamic project setting
• Fluency in French is required, good command of English essential

Are you ready to make an impact in a project that contributes to safe and efficient pharmaceutical manufacturing? We look forward to hearing from you.