CQV Engineer
2 weeks ago
Matthews, United States
Katalyst Healthcares and Life Sciences
Full time
Responsibilities:- Creation and revision of design specifications (FS, HDS, SDS) and Standard Operating Procedures (SOPs)
- Creation of qualification documents (IQ, OQ, PQ)
- Write change notes.
- Performing, analyzing and evaluation of Computational Fluid Dynamics (CFD) studies for pharmaceutical machines
- Participation in the preparation of process risk analysis
- Support commissioning and qualification at customer sites
- Support the company's strategic goals and values.
- Bachelor's degree (Engineering, Science, Technical) required
- 3 + years' experience in pharma technology required
- Knowledge of good documentation practices and good manufacturing practices required
- Experience in a regulated environment, qualification and/or validation required
- Strong technical expertise and analytical skills required
- Experience with ANSYS Discovery, ANSYS CFD Premium, or comparable computational fluid dynamics software preferred
- Proficient in mechanical 2D and 3D design software preferred (AutoCAD, Inventor, Solidworks)
- Able to read PLC programs preferred
- Able to read electrical schematics preferred
- Intermediate experience with Microsoft Office: Word /Excel /Visio /Project
- Available to travel up to 35%
- Knowledge of German language is advantageous
