Validation Engineer III
3 weeks ago
Location: Portsmouth, NH 03801
Duration: 12 Months
Description:
- This role is a senior CSV engineer requirement.
- CSV /Automation experience of 5+ years
- Hands on experience in Implementation & Validation of various computerized systems like PCS (DeltaV) / Client (Rockwell) / MES (Syncade) and Pi Historian / SCADA / PLC
- Strong knowledge of Software Development Lifecycle (SDLC), including 21CFR part 11/Annex 11, Data Integrity and computerized system validation requirements.
- Experience working independently as well as in a team-oriented, collaborative environment is essential.
- Author, Review, Approve and Execute CSV life cycle documentation.
- Experience working with and programming/commissioning/validating Delta V software platforms.
- Extensive understanding of 21 CFR Part 11/Annex 11, GAMP 5, and other regulatory guidance associated with computer/automation-based systems.
- Manage, document, and assess the software changes throughout the SDLC following client procedures.
- Knowledgeable of S88 Batch Standard is preferable.
- Recipe management DeltaV software development and testing are preferable.
- MES Recipe authoring and testing is preferable.
- Implementation and validation of QC system is preferable.
- Experience with Kneat is preferable.
- Strong verbal and written communication skills
- This role is 100% onsite.
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