Engineer, CSV & Validation Consultants

Hobson Prior; Schweiz; Vor Ort; CHF 95’000 - 120’000; Vollzeit

Zusammenfassung

A leading life sciences company is seeking an Engineer CSV and Validation Consultant to ensure compliance and validation of systems and processes. This role requires strong collaboration with internal and external teams, and familiarity with regulatory standards. Candidates should have a degree in engineering or related fields and significant skills in problem-solving and teamwork.

Qualifikationen

• Background in engineering, technical disciplines, or IT required.
• Knowledge of international regulatory standards like 21 CFR Part 11 is essential.
• Proficiency in English; knowledge of French is a plus.

Aufgaben

• Manage computer system validation (CSV) activities using risk-based approaches.
• Write and review validation documents including plans and protocols.
• Conduct periodic reviews to ensure systems remain compliant.

Kenntnisse

Strong communication skills

Proactive problem-solving

Teamwork skills

Ausbildung

Degree in engineering, technical disciplines, or IT

Tools

MES (Manufacturing Execution Systems)

ERP

LIMS

Jobbeschreibung

Are you an experienced and skilled engineer looking for your next step within the life sciences industry?

Hobson Prior is seeking an Engineer CSV and Validation Consultant to join a dynamic team in the life sciences industry. In this role, you will ensure that equipment, systems, and processes meet compliance standards and remain validated throughout their lifecycle. You will collaborate with internal teams and external vendors to maintain high-quality standards and support continuous improvement initiatives.

Please note that to be considered for this role you must have the right to work in this location.

Responsibilities:

• Plan and manage computer system validation (CSV) activities using risk-based approaches.
• Ensure all equipment, systems, and processes are validated and maintained according to policies and guidelines.
• Write and review validation documents, including plans, protocols, reports, and traceability matrices.
• Oversee testing activities, including managing vendors and internal testers.
• Conduct periodic reviews to ensure systems remain compliant and validated.
• Contribute to the development and updating of local procedures.
• Align site-specific CSV strategies with global standards.
• Lead risk assessments and manage change controls to evaluate impacts on validated systems.
• Coordinate validation activities across departments and with external vendors.
• Supervise internal and external resources for projects.
• Support audits by providing documentation and acting as a subject matter expert (SME).
• Build strong relationships with team members, customers, and suppliers.
• Identify and propose solutions for process improvements.

Key Skills and Requirements:

• Background in engineering, technical disciplines, or IT (degree or equivalent experience).
• Knowledge of international regulatory standards, including 21 CFR Part 11, EU GMP Annex 11, and GAMP.
• Familiarity with data integrity principles (ALCOA).
• Experience with IT systems such as MES (Manufacturing Execution Systems), ERP, LIMS, and process equipment interfaces.
• Strong communication and teamwork skills.
• Proactive problem-solving abilities.
• Proficiency in English; knowledge of French is a plus.

For more information, please contact Billy O'Brien.

If you are interested in applying to this exciting opportunity, then please click 'Apply' or to speak to one of our specialists visit the 'Contact Us' page.

Hobson Prior is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Hobson Prior is acting as an Employment Agency in relation to this vacancy.

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