Remote - Automation CSV Engineer (DeltaV)

Position Title & Basic Details

Were looking for an Automation CSV Engineer (DeltaV) based in [Location]. This is a Contract position requiring 5+ years of relevant experience. A Bachelors degree in Engineering or a related field is strongly preferred.

Overview

In this role, youll be responsible for reviewing and approving Kneat documents, resolving protocol execution issues, and supporting Computer System Validation (CSV) activities for DeltaV systems. The ideal candidate brings a solid foundation in DeltaV DCS and thrives in a fastpaced environment.

Key Responsibilities

• Review and approve Kneat documents including DeltaV software FATs, SATs, Automation Commissioning Test Protocols, software OQs, and Software Installation Verification protocols
• Assist in resolving protocol execution issues using critical analysis and develop sound, reasonable solutions
• Assist with the development of system requirements and specifications to ensure requirements are testable and meet 21 CFR Part 11
• Support generation of Kneat documents
• Review and approve Automation documentation including risk and impact assessments, computer systems validation plans, user requirements specifications, functional requirement specifications, traceability matrices, release reports, and all documents within the Automation Master Validation Plan
• Ensure Computer System Validation is conducted to a high standard, within budget, and on time
• Coordinate with various project workstreams including Automation, Automation System vendors, CSV, CQV, Utilities, Process Engineering, and others
• Attend regularly scheduled project status meetings as needed
• Complete Safety, Project Procedure, and Project Instruction training as required

Requirements

• Education: Bachelors degree in Engineering or related field
• Technical Expertise: Proficiency in Emerson DeltaV DCS; working knowledge of Kneat validation software
• Experience: Minimum 5 years of Computer System Validation experience in a cGMP pharmaceutical facility; 3+ years with DeltaV DCS
• Soft Skills: Excellent communication, collaboration, and problemsolving abilities

Preferred Qualifications

• Knowledge with Drug Substance Manufacturing (DSM)
• Experience with MasterControl, ComplianceWire, TrackWise, and Veeva

Why Join Us?

• Growth Opportunities: Work with a team that will enhance your technical development
• Innovative Environment: Engage with cuttingedge technologies and challenging projects
• Team Culture: Join a collaborative group that values teamwork, transparency, and innovation
• Interview Process
• Virtual Interviews: Conducted via Zoom
• OnSite Interviews: Final discussions may be at the [Company Location] to meet the broader team

Additional Information

• Must be authorized to work in the U.S. (US Citizen, Green Card, or valid Work Permit)
• Ability to attend inperson interviews as necessary
• Job type: Contract position
• Fulltime
• Onsite, remote, or hybrid role
• Duration: 612 Months
• Ref#: L797355X