Connect Tech+Talent is recruiting an experienced Automation CSV Engineer for an onsite, contract-to-hire opportunity in Redmond, Washington, USA.
Experience Required: 5+ years
Work Mode: Onsite
Employment Type: Contract-to-Hire (C2H)
Location: Redmond, WA, USA
Role Overview:
The Automation CSV Engineer will support validation, compliance, qualification, and lifecycle management of GMP automation and computerized systems within a regulated manufacturing environment.
Key Responsibilities:
- Develop and support validation strategies for GMP automation systems.
- Prepare, review, and execute validation protocols, test scripts, and qualification documentation.
- Support Factory Acceptance Testing (FAT), Site Acceptance Testing (SAT), Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).
- Conduct regression testing and automation functional testing.
- Ensure data integrity, regulatory compliance, and continued validated system status.
- Collaborate with Automation, Quality Assurance, IT/OT, Engineering, and Manufacturing teams.
- Support validation documentation, risk assessments, change control, deviations, and Corrective and Preventive Actions (CAPA).
Required Technical Skills:
- Hands-on experience with Emerson DeltaV.
- Experience with AVEVA / OSIsoft PI System and process historians.
- Strong knowledge of SCADA platforms, PLC/HMI controls, and batch applications.
- Experience with automation systems and supporting infrastructure.
- Hands-on experience with IQ/OQ/PQ protocols and qualification testing.
- Strong knowledge of GMP/cGMP, 21 CFR Part 11, and GAMP 5.
- Experience with validation documentation, risk assessments, change control, deviations, and CAPA.
Ideal Candidate:
A hands-on automation validation professional with strong Emerson DeltaV, PI System, SCADA, PLC/HMI, batch application, and GMP compliance experience.
Benefits Will be Discussed during interview.