Cqv Engineer

**Descripción**:
**What We Offer**:

- Continuous support and guidance from our experienced team
- Accommodation
- Motor and food expenses
- Comprehensive fiscal treatment
- Daily allowances
- Monthly flights
- Personalized career development plan

Your **main responsabilities** will include:

- Generating and executing CQV/validation lifecycle documentation: Risk Assessments, Validation Plans, URSs and CQV/validation protocols and reports (including FATs, SATs, IQs, OQs, PQs, etc.)
- Working as a seconded resource in a client-site
- To support and/or lead validation projects and activities on site, as directed and as appropriate
- To prepare validation plans in line with the strategic goals of the client and to manage timely and compliant delivery of the plan
- Experience in commissioning and validation of various new technologies and new equipment
- To develop and execute Commissioning & Qualification lifecycle protocols as per the specific project requirements
- Leading and supporting SATs
- Supporting and representing the technical quality team in meetings, visits, troubleshooting exercises and audits
- Ensuring manufacturing equipment is qualified in line with production schedule requirements
- Developing and writing validation procedures according to GMP and regulatory requirements
- Providing continuous improvement for existing validation procedures
- Be able to collect data and analyse via sophisticated computer software
- Work within the multifunctional project team, interacting and forming effective relationships with the key function representatives (e.g. Production, QA, Engineering)

**Requisitos**:
**What are we looking for?**
- Degree in Science or Engineering
- Strong understanding of a risk-based approach to commissioning and qualification within the biotechnology industry. Experience with ISPE best practice Annex 1 / GAMP-5/ Annex 15 GMP EU/ ASTM E2500/ electronic execution
- Strong working knowledge of applied statistics, quality systems and regulatory requirements across multiple health authorities.
- Expert in reviewing and writing technical reports
- Proven project management experience in a cross-functional environment (e.g. multi-site, technical development, other functions)
- Experience of sterile / biotech / single use equipment in the bio-pharmaceutical industry &/or API pharmaceutical environment (medical device industry experience also considered)
- Knowledge of safety, GMP and environmental regulatory requirements
- Ability to make decision under pressure and demonstrated strong communication/ leadership skills, great interpersonal and initiative skills
- Demonstrated ability to collaborate with senior stakeholders to achieve optimal outcomes
- English speaking is a must, knowledge of French/German is a plus
- Applicants shall have experience of equipment validation on multiple projects in the pharmaceutical and/or biopharmaceutical sectors

If you are passionate about making a global impact in the pharmaceutical industry and are ready for an exciting international opportunity, we want to hear from you