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- Aufgaben: Lead CQV activities for a High Bay GMP Warehouse, ensuring compliance and coordination.
- Arbeitgeber: Join a global leader in active pharmaceutical ingredient production and process support.
- Mitarbeitervorteile: Enjoy a 12-month contract with opportunities to work on cutting-edge projects.
- Warum dieser Job: Be part of a dynamic team impacting pharmaceutical manufacturing and enhancing public health.
- Gewünschte Qualifikationen: 8+ years of experience in CQV, with a degree in Mechanical or Chemical Engineering preferred.
- Andere Informationen: Fluent English required; German is a plus. Must have relevant Swiss/EU residency permit.
Das voraussichtliche Gehalt liegt zwischen 72000 - 100000 € pro Jahr.
CQV Engineer – GMP High Bay Warehouse – 6395
Our client, a global market leader in the production and process support of active pharmaceutical ingredients, both in the chemical and biotechnology sectors, is looking for a CQV Engineer GMP for a 12 months contract role to be based in the Stein area , Switzerland.
An ideal candidate is someone who has experience as a CQV Engineer to meet the needs for the High Bay GMP Warehouse at the site in Stein. The CQV Engineer will drive the execution and coordination of the defined CQ activities in the warehouse for both cold and ambient temperatures and support building.
Main Responsibilities:
- Ensure that CQV activities are executed in accordance with CORP 35, the C&Q Plan and supporting Validation Plans.
- C&Q SME for High Bay warehouse scope – cold and ambient (high preference).
- Support C&Q execution for key main equipment: Semi-automated and fully automated visual inspection machine, other small support equipment in Building 413 (LAF, thawing units, fridges, freezers, cold/freezer rooms, etc.), including alignment with execution approach of equivalent systems in QC building.
- Execution of the commissioning activities related to allocated areas or systems.
- Coordination of execution activities with supporting CSV Team and global IT teams.
- Lead C&Q testing activities supported by vendors and contractors.
- Develop any supporting validation plans related to scope of execution.
- Support the updates of Master C&Q Plan and supporting plans during project execution lifecycle.
- Interface with other disciplines: HSE, Automation, Electrical, Instrumentation, Operation and Engineering, etc.
- Assist the C&Q Lead with the Handover and Release process.
Qualifications and Experience:
- Relevant working/residency permit or Swiss/EU-Citizenship required.
- Experience in use of Kneat for documentation development and execution.
- A relevant Third Level or Professional Qualification.
- Ability to work well under pressure and within strict deadlines.
- Minimum of 8 Years extensive experience in areas/systems under future responsibility.
- Preferably Diploma level degree in Mechanical or Chemical Engineering.
- Previous experience in authoring CQV lifecycle documents necessary.
- Previous experience in qualifying a High Bay warehouse (ambient and 2 to 8 degree cold room) necessary.
- Proactive and able to work independently.
- Considerable experience with cGMP.
- Strong interpersonal and communication skills.
- Fluent English (C1 Level), German an advantage.
Seniority level
Not Applicable
Employment type
Contract
Job function
Engineering and Manufacturing
Industries
Pharmaceutical Manufacturing, Medical Equipment Manufacturing, and Warehousing and Storage
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CQV Engineer – GMP High Bay Warehouse - 6395 Arbeitgeber: CTC Resourcing Solutions AG
Kontaktperson:
CTC Resourcing Solutions AG HR Team
StudySmarter Bewerbungstipps 🤫
So bekommst du den Job: CQV Engineer – GMP High Bay Warehouse - 6395
✨Tip Number 1
Make sure to familiarize yourself with the specific requirements of CQV activities in GMP environments. Understanding CORP 35 and the C&Q Plan will give you a solid foundation to discuss your experience during the interview.
✨Tip Number 2
Highlight your experience with Kneat for documentation development. Being able to demonstrate your proficiency with this tool can set you apart from other candidates, as it's crucial for the role.
✨Tip Number 3
Prepare to discuss your previous experiences in qualifying High Bay warehouses, especially regarding ambient and cold room conditions. Real-life examples will showcase your expertise and problem-solving skills.
✨Tip Number 4
Since strong communication skills are essential, practice articulating your thoughts clearly and confidently. This will help you convey your ideas effectively during interviews and interactions with cross-functional teams.
Diese Fähigkeiten machen dich zur top Bewerber*in für die Stelle: CQV Engineer – GMP High Bay Warehouse - 6395
Tipps für deine Bewerbung 🫡
Understand the Role: Make sure to thoroughly read the job description for the CQV Engineer position. Highlight the key responsibilities and qualifications required, such as experience with Kneat and knowledge of cGMP.
Tailor Your CV: Customize your CV to reflect your relevant experience in CQV engineering, especially in high bay warehouses and cold storage environments. Emphasize your qualifications and any specific projects that align with the job requirements.
Craft a Strong Cover Letter: Write a cover letter that showcases your passion for the pharmaceutical industry and your specific experience related to the role. Mention your ability to work under pressure and your strong communication skills, as these are crucial for the position.
Proofread Your Application: Before submitting your application, carefully proofread all documents for spelling and grammatical errors. Ensure that your application is professional and polished, reflecting your attention to detail.
Wie du dich auf ein Vorstellungsgespräch bei CTC Resourcing Solutions AG vorbereitest
✨Showcase Your CQV Experience
Make sure to highlight your extensive experience in CQV activities, especially in relation to high bay warehouses. Be prepared to discuss specific projects where you successfully executed CQV processes and how you ensured compliance with relevant standards.
✨Familiarize Yourself with Kneat
Since experience with Kneat is essential for this role, brush up on your skills with this documentation tool. Be ready to explain how you've used it in past projects to develop and execute documentation effectively.
✨Demonstrate Your Interdisciplinary Collaboration Skills
This position requires coordination with various teams such as HSE, Automation, and Engineering. Prepare examples of how you've successfully collaborated with different disciplines in previous roles to achieve project goals.
✨Prepare for Technical Questions
Expect technical questions related to cGMP and the specific equipment you'll be working with, like semi-automated inspection machines. Brush up on your knowledge and be ready to discuss your hands-on experience with these systems.
