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- Aufgaben: Lead commissioning and qualification for QC lab systems and ensure compliance with GMP standards.
- Arbeitgeber: Join a dynamic team focused on quality and regulatory excellence in the life sciences sector.
- Mitarbeitervorteile: Enjoy a collaborative work environment with opportunities for professional growth and development.
- Warum dieser Job: Make a real impact in ensuring laboratory systems meet high-quality standards while working with cutting-edge technology.
- Gewünschte Qualifikationen: Bachelor’s degree in Life Sciences or Engineering with 5+ years of CQV experience required.
- Andere Informationen: Experience with Kneat for CQV execution is a plus; strong communication skills are essential.
Das voraussichtliche Gehalt liegt zwischen 48000 - 72000 € pro Jahr.
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Commissioning and Qualification Engineer, Stein
Location:
Job Category:
Job Reference:
JN -122024-101962_1734511683
Job Views:
20
Posted:
18.12.2024
Expiry Date:
01.02.2025
Job Description:
We are seeking a skilled C&Q Specialist to lead commissioning and qualification activities for QC laboratory systems, equipment, and support utilities. This role ensures compliance with GMP standards and regulatory requirements while supporting cross-functional teams and external vendors.
Key Responsibilities:
- Act as SME for QC laboratory C&Q scope.
- Plan, coordinate, and execute commissioning and qualification for lab systems (e.g., analytical instruments, HVAC, water systems).
- Develop and review protocols (IQ/OQ/PQ), validation plans, and reports.
- Coordinate with CSV and global IT teams.
- Identify and resolve risks, troubleshoot issues, and implement corrective actions.
- Maintain and report C&Q status to stakeholders.
Candidate Profile:
- Bachelor’s degree in Life Sciences or Engineering.
- 5+ years of CQV experience in a GMP environment.
- Proficiency with laboratory instruments (e.g., HPLC, GC, UV-Vis) and CSV for lab systems.
- Strong knowledge of IQ/OQ/PQ processes and regulatory standards (FDA, EMA, ISO).
- Experience with Kneat for CQV execution is an advantage.
- Excellent communication skills and cGMP knowledge.
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Commissioning and Qualification Engineer Arbeitgeber: Darwin Recruitment GmbH
Kontaktperson:
Darwin Recruitment GmbH HR Team
StudySmarter Bewerbungstipps 🤫
So bekommst du den Job: Commissioning and Qualification Engineer
✨Tip Number 1
Make sure to highlight your experience with commissioning and qualification in GMP environments during networking opportunities. Connect with professionals in the field on platforms like LinkedIn to learn more about their experiences and insights.
✨Tip Number 2
Attend industry conferences or workshops focused on laboratory systems and regulatory compliance. This will not only expand your knowledge but also help you meet potential colleagues and employers who value hands-on experience.
✨Tip Number 3
Familiarize yourself with the specific tools and software mentioned in the job description, such as Kneat for CQV execution. Being able to discuss your proficiency with these tools can set you apart from other candidates.
✨Tip Number 4
Prepare to discuss real-life scenarios where you've successfully managed risks or troubleshooting in a lab setting. Having concrete examples ready will demonstrate your problem-solving skills and expertise in C&Q activities.
Diese Fähigkeiten machen dich zur top Bewerber*in für die Stelle: Commissioning and Qualification Engineer
Tipps für deine Bewerbung 🫡
Understand the Role: Make sure to thoroughly read the job description for the Commissioning and Qualification Engineer position. Understand the key responsibilities and required qualifications, as this will help you tailor your application.
Highlight Relevant Experience: In your CV and cover letter, emphasize your 5+ years of CQV experience in a GMP environment. Be specific about your proficiency with laboratory instruments and any relevant projects you've worked on.
Showcase Your Skills: Clearly outline your knowledge of IQ/OQ/PQ processes and regulatory standards like FDA, EMA, and ISO. Mention any experience with Kneat for CQV execution, as this is considered an advantage.
Craft a Strong Cover Letter: Write a compelling cover letter that not only summarizes your qualifications but also demonstrates your passion for the role. Discuss how your skills align with the company's needs and your commitment to maintaining compliance with GMP standards.
Wie du dich auf ein Vorstellungsgespräch bei Darwin Recruitment GmbH vorbereitest
✨Show Your Expertise
Be prepared to discuss your experience with commissioning and qualification in detail. Highlight specific projects where you acted as a Subject Matter Expert (SME) and how you ensured compliance with GMP standards.
✨Know Your Protocols
Familiarize yourself with IQ/OQ/PQ processes and be ready to explain how you've developed and reviewed these protocols in past roles. This will demonstrate your technical knowledge and attention to detail.
✨Communicate Effectively
Since excellent communication skills are crucial for this role, practice articulating complex concepts clearly. Be prepared to discuss how you've coordinated with cross-functional teams and external vendors in previous positions.
✨Prepare for Problem-Solving Questions
Expect questions about troubleshooting and risk management. Think of examples where you identified issues during C&Q activities and the corrective actions you implemented to resolve them.
