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Qualification Engineer / Project Coordinator H/F

Réf.SDE-523 - 2019/10/08

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criteria

Location :
Switzerland
Business area :
Life Sciences
Job :
Engineering / Technical
Type of Contract :
Permanent
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For 50 years, we've been driven by the firm belief that engineers are the architects of tomorrow's world, leading the way with their daring, their expertise and their ability to push boundaries.
Every day, our 5,700 employees innovate for our clients, partnering the world's greatest engineering projects in the fields of energy, healthcare, life sciences and transport.
A fast-growing international Group, we are present in 14 countries (in Europe, the Middle East, Asia and Africa).

Well known for our expertise in CQV (Commissioning Qualification Validation) and specialists in projects with strict technical and regulatory constraints, we partner pharmaceutical laboratories and high-tech industrial players to manage their capital expenditure and meet the challenges they face in terms of increasing safety and reducing costs and market lead times.
We innovate for our clients and provide them with disruptive technologies in the areas of data integrity, cybersecurity and predictive maintenance.

Job Description

Purpose and key role:

As a consultant, you will represent Assystem Care in client's project in various qualification equipment projects. Your main mission will be to support our client in their projects in order to let them focus on their core business and the patient.

Key responsibilities:

• Coordinate activities with the supplier, manage aspects of the logistic process,
• Create a detailed schedule of qualification activities in collaboration with project manager,
• Commissioning and qualification of equipment (FAT / SAT),
• Participate in the writing process of draft risk analyses and criticality analyses,
• Implement the qualification master plan and deploy the strategy to the system concerned,
• Carry out qualification activities (IQ; OQ; PQ), and collate all documentation,
• Liaise with Engineering, C&Q and Quality Project Teams
• Read and validate all project deliverables, and ensure consistency and quality through all documentation
•Suggest optimizations based on best practice approach and experience with procedures



Profile

• Master degree in Pharmacy or Process Engineering (chemistry, biotechnology, biochemistry, chemistry or similar)
• Minimum 2 years' experience in qualification activities in pharmaceutical industry
• Very good knowledge of GMP
• Good team spirit, with a positive attitude
• Interpersonal and influencing skills, communication skills
• Excellent command of English,with a working knowledge of French or German


At Assystem, everyone holds the reins for their own careers. Our role is to offer you the opportunities and resources you need to reach your full potential.

So why not join us and help shape the engineering landscape of the future?

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