Description
We are seeking a motivated and skilled individual who is passionate about the future of science. If you are eager to contribute to our vision and make a meaningful impact, we encourage you to apply. As Qualification Engineer you will be responsible for equipment, computer system and facility qualification projects and the execution of commissioning and qualification documents for equipment and systems in accordance with the Site Validation Master Plan, project-specific validation plans and departmental SOPs.
About Ascend:
Ascend is pioneering the future of healthcare through relentless innovation, our forward-thinking company is on a mission to manufacture safe, efficacious, and scalable gene therapies. Our vision is to set a new standard for gene therapy manufacturing through continuous scientific and process innovation. Our teams, rooted in biopharma, possess regulatory knowledge and prioritize the quality and potency of manufacturing high-class products.Join us to pursue your passion and make a difference in the industry where there are no limits to what we can achieve.
- Lead and provide expertise in all equipment qualification matters.
- Develop user and design specifications for equipment and systems.
- Author qualification/validation plans, traceability matrices, test protocols (IQ/OQ/PQ), and summary reports.
- Execute equipment and system testing, including IQ (Installation Qualification), OQ (Operational Qualification), and PQ (Performance Qualification).
- Review and approve lifecycle documentation related to commissioning, qualification, and validation.
- Conduct and oversee computerized system validation for GMP equipment, ensuring compliance with GxP, 21 CFR Part 11, and related regulations.
- Manage and document calibration, qualification, and maintenance activities, ensuring continuous compliance and operational readiness.
- Develop and execute a preventive maintenance program to optimize equipment performance and minimize downtime.
- Troubleshoot and diagnose equipment failures, swiftly determining root causes and implementing corrective actions.
- Investigate deviations and safety issues, utilizing problem-solving methodologies to resolve and prevent future occurrences.
- Conduct risk assessments and develop mitigation strategies for engineering and maintenance activities.
- Participate in regulatory audits to ensure compliance with relevant regulations and standards.
- Author and maintain SOPs and work instructions for QC equipment.
- Coordinate external maintenance and repairs for QC equipment.
- Regularly review audit trails to ensure compliance with data integrity standards.
- Provide training and support to QC personnel on equipment use and troubleshooting procedures.
- Uphold GMP principles and ensure data integrity throughout all processes.
Requirements
- Bachelor’s degree in Life Science/Engineering/Analytical Chemistry or related field and 5+ years of experience in a regulated industry
- Strong experience with qualification of analytical equipment
- Experience with validation of GMP computerized systems
- GMP expertise (especially Annex 15) and good understanding of working in a regulated environment
- Proactive mindset
- Good team working spirit
- Fluent in English and German
- Good knowledge of Microsoft Office
- Ability to adapt to changing priorities effectively and work in a start-up environment
- Strong communication skills and ability to effectively collaborate in a dynamic, cross functional matrix environment
- Strong problem-solving skills
Benefits
- 30 days holiday
- Performance based bonus
- More to come as we grow
To embark on this journey, please submit your resume and a cover letter outlining your qualifications, and interest in this role. We at Ascend embrace diversity and do not tolerate discrimination. We enthusiastically anticipate receiving all applications from individuals who align with our vision., While we appreciate all submissions, we'll reach out only to those selected for an interview. Join us as we shape the future together with boundless excitement and limitless possibilities! Thank you for considering joining our team at Ascend.
