About Amtera: Amtera is a leading consultancy firm specializing in engineering, technology, and compliance. Our mission is to foster advancement in these fields and provide innovative solutions to our clients across a wide range of sectors, including Biopharma, Pharmaceutical, Chemical, FMCG, Medical Devices, as well as Energy, Banking, and Insurance. At Amtera, we are dedicated to excellence and thrive on delivering impactful results through cutting-edge technology and engineering practices.
Position Overview: We are seeking a skilled and experienced CQV (Commissioning, Qualification, and Validation) Engineer to join our team for a biopharmaceutical client in the Basel area. This role focuses on ensuring that all systems and processes within the client’s facility meet the rigorous standards of the biopharma industry, including GMP, FDA, and EU regulations. The ideal candidate will have a strong background in CQV activities within the biopharmaceutical sector.
Key Responsibilities:
- Develop and execute commissioning, qualification, and validation protocols for biopharmaceutical manufacturing equipment and processes.
- Ensure compliance with GMP, FDA and other relevant industry standards and regulations.
- Perform risk assessments and impact assessments to determine the validation scope and approach.
- Prepare and review validation documentation, including URS, FRS, DQ, IQ, OQ, and PQ.
- Collaborate with cross-functional teams, including engineering, quality assurance, and production, to ensure successful project execution.
- Conduct FAT (Factory Acceptance Testing) and SAT (Site Acceptance Testing) to verify equipment performance.
- Manage change control processes and ensure that all changes are documented and validated.
- Troubleshoot and resolve issues related to equipment and process validation.
- Provide training and support to client personnel on validation procedures and compliance requirements.
- Maintain accurate and up-to-date records of all CQV activities and documentation.
Key Requirements:
- Bachelor’s degree in Engineering, Biotechnology, or a related field.
- Proven experience in commissioning, qualification, and validation within the biopharmaceutical industry.
- In-depth knowledge of GMP regulations and guidelines, including FDA, EMA, and ICH standards.
- Strong understanding of biopharmaceutical manufacturing processes and equipment.
- Experience with risk-based validation approaches and quality risk management.
- Excellent problem-solving and analytical skills.
- Strong communication and interpersonal skills, with the ability to work effectively with cross-functional teams.
- Detail-oriented with strong organizational skills and the ability to manage multiple priorities.
- Proficiency in using validation software and tools is a plus.
- Willingness to travel to client sites as needed.
Why Join Us?
- Opportunity to work on high-impact projects with a leading biopharmaceutical client in the Basel area.
- Collaborate with a team of experts dedicated to advancing engineering, technology, and compliance.
- Be part of a forward-thinking company that values your professional growth and development.
- Enjoy a dynamic and supportive work environment in the Basel area.
Amtera is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.
