Computer Systems Validation Engineer
Techneeds
- Portsmouth, NH
- $50.00 per hour
- Contract
- Full-time
Seeking no less than 5 years of CVS/Automation experience working with systems such as PCS (DeltaV) / BAS (Rockwell) / MES (Syncade) and Pi Historian / SCADA / PLC
Must have Strong knowledge of Software Development Lifecycle (SDLC), including 21CFR part 11/Annex 11, Data Integrity and computerized system validation requirements. 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 Lonza procedures.
Knowledgeable of S88 Batch Standard is preferable
Recipe management DeltaV software development and testing is 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 in Portsmouth, NH. NO RELOCATION; must be local.
Pay range starts at $50 per hour and up depending on experience.