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- Aufgaben: Join our team as a Commissioning Engineer, ensuring top-notch quality in lab equipment and systems.
- Arbeitgeber: Work with a leading pharmaceutical and biotech company dedicated to innovation and quality.
- Mitarbeitervorteile: Enjoy a contract role with opportunities for growth in a dynamic industry.
- Warum dieser Job: Be a key player in maintaining high standards and compliance in life sciences.
- Gewünschte Qualifikationen: Bachelor’s degree in Life Sciences or Engineering; 5+ years of relevant experience required.
- Andere Informationen: Only applicants with the right to work in Switzerland will be considered.
Das voraussichtliche Gehalt liegt zwischen 48000 - 84000 € pro Jahr.
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Direct message the job poster from EPM Scientific
Associate Consultant – Life Sciences at EPM Scientific (Contracts)
Our client, a leading pharmaceutical and biotech company, is seeking a talented and driven Commissioning & Qualification (C&Q) Engineer to join their Quality Control Laboratory project team.
This role involves ensuring the successful commissioning, qualification, and ongoing validation of laboratory equipment, systems, and processes to comply with regulatory standards and ensure the highest levels of quality.
The C&Q Engineer will play a crucial role in supporting the setup, qualification, validation, and maintenance of laboratory environments.
Responsibilities:
- C&Q SME for QC Laboratory scope.
- Plan, coordinate, and execute commissioning and qualification activities for QC laboratory systems, equipment, and support utilities as needed (e.g., analytical instruments, laboratory systems, HVAC, and water systems).
- Coordination of execution activities with supporting CSV Team and global IT teams.
- Lead C&Q testing activities supported by external vendors and/or contractors.
- Develop any supporting validation plans related to scope of execution.
- Develop and review Qualification Protocols (IQ/OQ/PQ), commissioning documents, and final reports, ensuring compliance with relevant standards (GxP, FDA, EMA, ISO, etc.).
- Support the updates of Master C&Q Plan and supporting plans during project execution lifecycle.
- Maintain and report C&Q status to the C&Q Lead, which can be reported into project stakeholders meetings (e.g. Tier 1 meetings, Wall meetings).
- Generate, review, approve, CQV test scripts in accordance with Verification Plans and any applicable site commissioning or validation plans or procedures.
- Identify potential risks or issues during commissioning and qualification activities and lead troubleshooting efforts when necessary. Implement corrective actions as needed.
- Assist the C&Q Lead with the Handover and Release process.
Candidate profile:
- Bachelor’s degree in Life Sciences or Engineering.
- 5+ years of commissioning, qualification, or validation experience in a GMP environment in a Life Sciences relevant discipline.
- Familiarity with laboratory instruments such as HPLC, GC, UV-Vis spectrophotometers, and other analytical equipment.
- Experience with computer systems validation (CSV) for laboratory systems.
- Previous experience in authoring CQV lifecycle documents necessary.
- Strong knowledge of qualification and validation processes for laboratory systems and equipment.
- Experience in the preparation and review of IQ/OQ/PQ protocols and reports.
- Experience using Kneat for CQV test execution.
- Fluent English language written and verbal communication skills.
- cGMP knowledge and knowledge of regulatory requirements.
For further information about this position, please apply with your CV.
Please note, only those with the right to work in Switzerland can apply!
Seniority level
Mid-Senior level
Employment type
Contract
Job function
Engineering, Product Management, and Quality Assurance
Industries
Pharmaceutical Manufacturing and Biotechnology Research
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Commissioning Engineer Arbeitgeber: EPM Scientific
Kontaktperson:
EPM Scientific HR Team
StudySmarter Bewerbungstipps 🤫
So bekommst du den Job: Commissioning Engineer
✨Tip Number 1
Familiarize yourself with the specific laboratory instruments mentioned in the job description, such as HPLC and GC. Having hands-on experience or knowledge about these tools will give you an edge during discussions with the hiring team.
✨Tip Number 2
Network with professionals in the pharmaceutical and biotech industries, especially those who have experience in commissioning and qualification. They can provide insights and potentially refer you to opportunities within their organizations.
✨Tip Number 3
Stay updated on the latest regulatory standards and guidelines related to GxP, FDA, and EMA. Demonstrating your knowledge of these regulations during conversations can showcase your commitment to quality and compliance.
✨Tip Number 4
Prepare to discuss your previous experiences with CQV lifecycle documents and any challenges you've faced in commissioning and qualification processes. Real-life examples will help illustrate your expertise and problem-solving skills.
Diese Fähigkeiten machen dich zur top Bewerber*in für die Stelle: Commissioning Engineer
Tipps für deine Bewerbung 🫡
Tailor Your CV: Make sure your CV highlights relevant experience in commissioning, qualification, and validation within a GMP environment. Include specific examples of laboratory systems and equipment you have worked with, such as HPLC or GC.
Craft a Strong Cover Letter: Write a cover letter that emphasizes your 5+ years of experience in the field. Discuss your familiarity with regulatory standards like GxP, FDA, and EMA, and how you can contribute to the Quality Control Laboratory project team.
Highlight Technical Skills: Clearly outline your technical skills related to CQV lifecycle documents, computer systems validation (CSV), and any experience with Kneat for test execution. This will demonstrate your capability to handle the responsibilities of the role.
Proofread Your Application: Before submitting, carefully proofread your CV and cover letter for any grammatical errors or typos. Ensure that your English language skills are reflected accurately, as strong communication is essential for this position.
Wie du dich auf ein Vorstellungsgespräch bei EPM Scientific vorbereitest
✨Know Your Technical Stuff
Make sure you brush up on your knowledge of commissioning and qualification processes, especially in a GMP environment. Be ready to discuss specific laboratory instruments like HPLC and GC, as well as your experience with computer systems validation.
✨Prepare for Scenario Questions
Expect questions that ask you to describe how you would handle specific challenges during the commissioning and qualification process. Think about past experiences where you identified risks or implemented corrective actions.
✨Show Your Team Spirit
This role involves coordination with various teams, including CSV and global IT. Be prepared to talk about your experience working collaboratively and how you’ve successfully led projects or activities with external vendors.
✨Communicate Clearly
Since strong communication skills are essential, practice explaining complex technical concepts in simple terms. Be ready to discuss how you maintain and report C&Q status to stakeholders effectively.
