Position: Senior CSV Engineer
Duration: Full Time
Location: Remote
JOB DESCRIPTION
Senior CSV Engineer Responsibilities:
Our team needs a senior level CSV Engineer with ALM experience, ideally with Polarion. Experience with ALM tools such as Kneat, Valgenesis may be considered in lieu of Polarion experience. This person should have strong lab informatics (LIMS, data archive, ELN, etc.), good/deep LabVantage experience, and be well versed in CSA methodology and be able to handle projects (from a technical and validation perspective) such as:
1. Calculation validations in LabVantage
2. Instrument integration with LabVantage
3. JMP/Statistica integration with LabVantage
4. Data migration from legacy stability system into LV and legacy system decommissioning
5. Integration of Sarepta LIMS with CMO LIMS
6. Splash lake
A minimum of a Bachelor’s degree in an Engineering or Scientific degree and 6-10 years of role relevant experience
• Demonstrated experience working with Polarion highly preferred, MUST have significant experience using ALM software
• Strong Lab Informatics experience
• Direct experience with LIMS (LabVantage)
• Experience authoring/editing/executing validation documents for laboratory equipment
• Working knowledge of FDA regulations, ISPE guidelines and ISO standards including:
- Good Documentation Practice (GDP) in pharmaceutical environment
- 21 CFR Part 11