Execution Engineer for Validation Protocols
vor 4 Wochen
Job Title: CSV Execution Engineer
Job Description:
We are seeking a skilled CSV Execution Engineer to support our projects in the execution of validation protocols. This role involves collaborating with various teams to ensure compliance with CQV/CSV processes and maintaining project timelines.
Key Responsibilities:
- Participate in system classification assessments and collaborate with CSV subject matter experts.
- Create and execute CSV documents following standard operating procedures and guidelines.
- Engage in FAT and SAT testing and create detailed validation protocols and reports.
- Work closely with CSV Regional Leads or CQV Leads to support operational teams on technical changes and life cycle activities.
- Ensure compliance with CQV/CSV guidelines, local procedures, and detect any gaps in compliance.
Required Qualifications:
- Technical degree in engineering or applied sciences, or equivalent experience.
- Experience in regulated industries or engineering environments, particularly in hands-on roles.
- Basic knowledge of ISPE GAMP5, ASTM guidelines, and regulatory requirements for GxP.
- Familiarity with biologics (mammalian, CGT) or chemical manufacturing technologies is highly desirable.
- Understanding of automation and data flow processes, as well as data integrity principles (ALCOA+).
Skills and Competencies:
- Strong analytical skills and experience working with complex data sets to support decision-making.
- Excellent collaboration skills, with the ability to work in a matrix environment.
- Proficiency in English, with a strong command of German (reading and writing).
- Ability to prioritize tasks effectively and work both independently and within a team.
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