Equipment Qualification/Validation Senior Engineer F/M
Suisse - Suisse Romande
CVO/CH/ING/1050
Since 1995, CVO-EUROPE’s multidisciplinary team has been supporting life science companies at every stage (design, validation, operation, digital transformation) of critical activities that may affect product quality, data integrity and patient health, whilst ensuring the compliance of their systems, equipment, processes and data.
With its comprehensive service range (consulting, shared service center, auditing, and instructional engineering), the CVO-EUROPE Group is committed to bringing its clients effective and innovative solutions whilst staying true to the human values that have characterized it from the outset.
With its comprehensive service range (consulting, shared service center, auditing, and instructional engineering), the CVO-EUROPE Group is committed to bringing its clients effective and innovative solutions whilst staying true to the human values that have characterized it from the outset.
To support our development, we are looking for :
Equipment Qualification/Validation Senior Engineer F/M
Permanent contract
Responsibilities
You will be in charge of the qualification of equipment related to production for major companies in the Life Sciences Industry.
Your main tasks will be (not exhaustive list) to:
• Coordinate various projects,
• Write qualification test protocols,
• Write qualification documents related to processes (manufacturing equipment, packaging, filling, etc.),
• Participate, execute and/or supervise the execution of tests (IQ, OQ, PQ),
• Manage non-conformities and change,
• Write validation reports and quality documents.
Your main tasks will be (not exhaustive list) to:
• Coordinate various projects,
• Write qualification test protocols,
• Write qualification documents related to processes (manufacturing equipment, packaging, filling, etc.),
• Participate, execute and/or supervise the execution of tests (IQ, OQ, PQ),
• Manage non-conformities and change,
• Write validation reports and quality documents.
Qualifications/Skills
• You have a degree in Life Sciences, engineering or equivalent by experience.
• You have at least 3 years of experience in the qualification of production, manufacturing or packaging equipment in the Life Sciences Industry.
• You are used to work in regulatory environment and have strong knowledge of regulatory standards related to pharmaceutical or biotechnology environment (GMP, GLP, ICH, 21 CFR, etc.).
• You speak fluently French and English.
• You have strong communication skills and an analytical thinking.
• You are mobile, flexible and rigorous.
• Your social skills enable you to work in team; you are an autonomous person on your activities.
We offer:
- The opportunity to develop your career within a people-oriented group operating at an international level, with the scope to get involved with challenging projects.
- Approachable management and a strong company culture that focuses on professional and personal fulfilment.
- A wide range of career development opportunities.
- Continuing professional development and personalised career management.
If you are looking for a satisfying career, full of rewarding and varied experiences, with the possibility for development, apply to join the team at CVO-EUROPE!
• You have at least 3 years of experience in the qualification of production, manufacturing or packaging equipment in the Life Sciences Industry.
• You are used to work in regulatory environment and have strong knowledge of regulatory standards related to pharmaceutical or biotechnology environment (GMP, GLP, ICH, 21 CFR, etc.).
• You speak fluently French and English.
• You have strong communication skills and an analytical thinking.
• You are mobile, flexible and rigorous.
• Your social skills enable you to work in team; you are an autonomous person on your activities.
We offer:
- The opportunity to develop your career within a people-oriented group operating at an international level, with the scope to get involved with challenging projects.
- Approachable management and a strong company culture that focuses on professional and personal fulfilment.
- A wide range of career development opportunities.
- Continuing professional development and personalised career management.
If you are looking for a satisfying career, full of rewarding and varied experiences, with the possibility for development, apply to join the team at CVO-EUROPE!
publication date : 19/02/2021