What are the responsibilities and job description for the CSV Consultant-MES position at arval services?
We are looking for an MES CSV Engineer with experience in the pharmaceutical industry validating MODA ES or a similar system (Syncade, PAS-X, Pharma Suite). The site is not fit for manufacturing right now, and they are creating project teams based on initial recommendations to perform a more involved gap assessment and make a more robust remediation plan from an IT CSV perspective. To get back up to manufacturing, site will be switching from MODA to a paper-based system until remediation is complete and MODA can be reimplemented correctly.
- Create/update SOPs, trainings, or validation documentation associated with life cycle management approach, traceability, end-to-end testing, data process maps, and periodic reviews.
- Author and (as applicable) execute validation documentation associated with functional specifications, interfaces, upstream/downstream units, and batch reports.
- 2 years working with hands on validation for MODA ES (or similar system) who understand how the functional and fixed specs tie in, what type of updates might be needed, and how that ties in to testing in the system
Education: BS Degree preferred.
SKILLS: Pharmaceutical, CSV, MODA (or similar system, Syncade, PAS-X, Pharma Suite).
Job Type: Contract
Pay: $48.00 per hour
Schedule:
- 8 hour shift
- Day shift
- Monday to Friday
Education:
- Master's (Required)
Experience:
- Pharmaceutical: 3 years (Required)
- MODA: 3 years (Required)
- PAS-X: 3 years (Required)
- Syncade: 3 years (Required)
Work Location: In person
Salary : $48
