Validation Lead - DeltaV

USDM Life Sciences is a premier consulting company with 20+ years of experience assisting heavily regulated biotech, medical device, and pharmaceutical companies with their GxP technologies to accelerate growth. Our deep domain knowledge and technology expertise in life sciences business processes are what set us apart. From strategy to implementation and adoption, we have delivered thousands of GxP projects globally.

As part of the USDM team, you have the opportunity to work with cutting-edge technologies through our many partnerships with companies like Microsoft, Google, Oracle, Docu Sign, Box, and many more. From molecule to market, you will help connect technology, people, and data in new ways to generate real-time insights to improve business outcomes for USDM's clients. Are you ready to make an impact and drive real digital transformation in life sciences?

Founded in Santa Barbara in 1999, USDM has grown to a progressive, global company with 300+ remote employees and offices throughout the US, Canada, and Germany.

Hiring a senior DeltaV Engineer with 10+ years of experience designing, configuring, and validating Emerson DeltaV distributed control systems (DCS) in GxP-regulated pharmaceutical or biotech manufacturing environments. The ideal candidate will bring deep expertise in DeltaV batch processing (S88), computer system validation (CSV), and 21 CFR Part 11 compliance, and will partner closely with process engineering, quality assurance, and validation teams at Gilead Sciences to deliver inspection-ready control system solutions.

• Design, configure, and commission Emerson DeltaV DCS systems for pharmaceutical batch and continuous manufacturing processes in compliance with GxP regulations.
• Develop and maintain DeltaV control modules, equipment modules, phase logic, and batch recipes using S88 standards.
• Author and execute validation lifecycle documentation including User Requirements Specifications (URS), Functional Design Specifications (FDS), Configuration Specifications (CS), IQ, OQ, and PQ protocols.
• Lead Factory Acceptance Testing (FAT) and Site Acceptance Testing (SAT) activities in coordination with vendor and site engineering teams.
• Support 21 CFR Part 11 compliance activities including audit trails, electronic records management, and access control configuration within Delta
  
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• Perform and document change control activities for DeltaV system modifications, following GAMP 5 methodology and site-specific change management procedures.
• Troubleshoot and resolve DeltaV system issues, including hardware faults, communication failures, and control logic deficiencies; provide root cause analysis and CAPA documentation.
• Manage DeltaV Alarm Management activities including alarm rationalization, alarm database maintenance, and compliance with ISA-18.2 standards.
• Collaborate with process engineers, validation teams, and quality assurance to ensure control system designs meet process requirements and regulatory standards.
• Maintain and update P&IDs, loop diagrams, and cause-and-effect matrices as part of ongoing system lifecycle management.
• Provide technical oversight and mentoring for junior control system engineers and site automation technicians.
• Support regulatory inspections and internal audits, including preparation of system documentation packages and audit-ready deliverables.
• Coordinate with Emerson and third-party vendors for hardware procurement, software upgrades, and system lifecycle planning.
• Develop and maintain DeltaV system backup, disaster recovery, and cybersecurity procedures in line with site IT/OT security policies.

• Minimum of 10 years of hands-on experience engineering, configuring, and validating Emerson DeltaV DCS systems, preferably in pharmaceutical, biotech, or other FDA-regulated manufacturing environments.
• Demonstrated proficiency with DeltaV Batch (S88), DeltaV Operate HMI, DeltaV Live, and DeltaV Continuous Historian.
• Strong working knowledge of GxP regulatory requirements including 21 CFR Parts 11 and 211, GAMP 5, and EU Annex 11.
• Experience authoring and executing computer system validation (CSV)…