Qualification Engineer
il y a 3 semaines
We are seeking a highly skilled Qualification Engineer to join our team at Abylsen ST RA, a leading engineering consulting group in the industry and tertiary sectors. As a Qualification Engineer, you will play a crucial role in supporting our clients in their innovation, R&D, operational performance, and digital projects.
Main Responsibilities:- Risk Analysis and Qualification Testing: Conduct thorough risk analyses to define qualification tests and ensure compliance with regulatory requirements.
- Qualification and Validation Strategies: Develop and implement qualification and validation strategies to ensure the quality and safety of our clients' products.
- Documentation and Reporting: Prepare and maintain high-quality qualification documentation, including QC, FAT, SAT, QI, QO, and QP reports.
- Qualification Testing and Evaluation: Perform qualification tests according to established schedules and evaluate results to identify areas for improvement.
- Collaboration and Communication: Participate in C&Q activity meetings, provide progress reports, and collaborate with cross-functional teams to ensure seamless project execution.
The ideal candidate will hold a Bachelor's or Master's degree in engineering or a related field, with at least 2 years of experience in equipment, premises, and/or HVAC qualification in pharmaceutical/biotech projects. Proficiency in pharmaceutical regulations (GMP, cGMP, 21 CFR) and strong technical documentation skills are required. Excellent communication, analytical, organizational, and problem-solving skills are essential. Fluency in English is a must.
We offer a dynamic and innovative work environment, opportunities for professional growth, and a competitive compensation package. If you are a motivated and detail-oriented individual with a passion for quality and safety, we encourage you to apply.
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Qualification Validation Engineer
il y a 1 semaine
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