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- Aufgaben: Lead qualification and validation for pharmaceutical equipment and systems.
- Arbeitgeber: Join a top-tier pharmaceutical company based in Switzerland, known for innovation.
- Mitarbeitervorteile: Enjoy a 6-month contract with potential for growth and valuable experience.
- Warum dieser Job: Make an impact in the pharma industry while working with cutting-edge technology.
- Gewünschte Qualifikationen: BS/MS in Engineering or equivalent; experience in Pharmaceutical Validation required.
- Andere Informationen: Fluency in English is essential; French is a plus. No motivational letter needed!
Das voraussichtliche Gehalt liegt zwischen 60000 - 84000 € pro Jahr.
For our client, a leading and innovative pharmaceutical company with its international headquarter based in the French part of Switzerland, we are searching for a:
Your main tasks
- Perform Qualification/Validation Lead role for a defined validation/qualification area.
- Develop and justify the C&Q and CSV approach based on risk and scientific rationale.
- Ensure equipment and systems are qualified, validated and maintained in compliance with local policies, guidelines, and procedures during their lifecycle.
- Author and when required review validation documents, including requirement specifications, design qualification, qualification/validation plans, protocols, reports, traceability matrix and qualification/validation summary reports.
- Execute qualifications/validations for equipment and/or system or manage people with the role of tester (including vendors) for all equipment and systems across the site, including QC, warehouse, facilities, lab equipment, utilities, and computer system validation.
- Define and execute periodic activities maintaining qualified/Validated states of equipment, analytical instruments, utilities & facilities, and computerized system (Re-qualification).
- Contribute to the development and maintenance of the local site procedures.
- Ensure the Validation strategy on site fit with global validation strategy in collaboration with global team.
- Lead risk assessments and risk management teams.
- Review/assess change controls and maintenance interventions, evaluating the impact upon qualified systems & validated processes, and documents required actions.
- Co-ordinate qualification and validation execution activities, including external vendors and internal departments.
- Participate in internal and external audits as SME, by answering questions, reviewing qualifications and validations with auditors, and providing documentation.
Your profile
- BS/MS in Engineering/Technical discipline or equivalent experience
- Several Years’ experience with Pharmaceutical Validation
- Strong Knowledge with current international regulatory regulations, cGxP requirements and best practices, including 21 CFR part 11, 210 and 211, Annex 11, EU-GMP guidelines and GAMP.
- Good ALCOA & Data Integrity knowledge
- Knowledge of pharmaceutical facilities (including HVAC and utilities), manufacturing and laboratory equipment/systems and computerized system validation (CSV)
- Communicates pro-actively and collaboratively.
- Proactively identifies problems and recommends solutions Team player: ability to interact effectively with team and customers.
- Good level of English, French is ideal but not mandatory
Sebastian Pal is looking forward to receiving your application documents via our job portal (CV, diploma, reference letters; no motivational letter necessary).
Full discretion is guaranteed and we will gladly answer any additional questions.
AurigaVision AG
Herr Sebastian Pal
#J-18808-Ljbffr
Engineer, C&Q and CSV (Ref. 2498) - 6 months contract Arbeitgeber: AurigaVision AG
Kontaktperson:
AurigaVision AG HR Team
StudySmarter Bewerbungstipps 🤫
So bekommst du den Job: Engineer, C&Q and CSV (Ref. 2498) - 6 months contract
✨Tip Number 1
Make sure to familiarize yourself with the latest international regulatory regulations and cGxP requirements. This knowledge is crucial for the role, and being able to discuss these topics confidently during your interview will set you apart.
✨Tip Number 2
Highlight your experience with pharmaceutical validation in your conversations. Be prepared to share specific examples of how you've successfully managed qualification and validation processes in previous roles.
✨Tip Number 3
Demonstrate your teamwork skills by discussing how you've collaborated with cross-functional teams in the past. This role requires effective interaction with various departments, so showcasing your ability to work well with others is key.
✨Tip Number 4
If you have any experience with risk assessments or managing change controls, be sure to mention it. This is a significant part of the job, and showing that you have hands-on experience will strengthen your candidacy.
Diese Fähigkeiten machen dich zur top Bewerber*in für die Stelle: Engineer, C&Q and CSV (Ref. 2498) - 6 months contract
Tipps für deine Bewerbung 🫡
Understand the Role: Make sure to thoroughly read the job description and understand the key responsibilities and qualifications required for the Engineer, C&Q and CSV position. Tailor your application to highlight relevant experiences.
Highlight Relevant Experience: In your CV, emphasize your experience with pharmaceutical validation and any specific projects that align with the tasks mentioned in the job description. Use clear examples to demonstrate your knowledge of cGxP requirements and regulatory regulations.
Prepare Your Documents: Gather all necessary documents such as your CV, diploma, and reference letters. Ensure that these documents are up-to-date and formatted professionally, as they will be crucial in making a good first impression.
Submit Application via Job Portal: Follow the instructions provided by AurigaVision AG to submit your application through their job portal. Double-check that all documents are attached and that your information is accurate before hitting 'submit'.
Wie du dich auf ein Vorstellungsgespräch bei AurigaVision AG vorbereitest
✨Understand the Regulatory Landscape
Make sure you are well-versed in current international regulatory regulations, cGxP requirements, and best practices. Familiarize yourself with 21 CFR part 11, 210 and 211, Annex 11, EU-GMP guidelines, and GAMP to demonstrate your expertise during the interview.
✨Showcase Your Experience
Prepare to discuss your previous experience with pharmaceutical validation in detail. Highlight specific projects where you performed qualification/validation lead roles and how you ensured compliance with local policies and guidelines.
✨Emphasize Team Collaboration
Since this role requires effective interaction with teams and customers, be ready to provide examples of how you've successfully collaborated in past projects. Discuss your approach to problem-solving and how you proactively identify issues.
✨Prepare for Technical Questions
Expect technical questions related to qualification and validation processes, including risk assessments and change controls. Brush up on your knowledge of pharmaceutical facilities, HVAC systems, and computerized system validation to confidently answer these queries.
