Validation Lead - DeltaV

About USDM

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, DocuSign, 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. 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.

Nature and Scope of Job

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.

Responsibilities

• 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 DeltaV.
• 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.

Required Qualifications

• 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) documentation — URS, FDS, IQ, OQ, PQ — to GxP standards.
• Proficiency in S88 batch process design and recipe management, including phase, operation, and unit procedure logic.
• Experience with DeltaV network architecture, including HART, FOUNDATION Fieldbus, DeviceNet, PROFIBUS, and Ethernet-based I/O.
• Strong understanding of ISA-5.1 (P&ID symbols), ISA-88, ISA-95, and ISA-18.2 alarm management standards.
• Experience supporting FAT, SAT, commissioning, and startup activities for new DCS installations and system upgrades.
• Ability to interpret and redline P&IDs, loop diagrams, and instrument data sheets.
• Demonstrated experience working within formal change control systems and electronic document management systems (EDMS).
• Strong analytical and problem-solving skills with the ability to perform root cause analysis and develop corrective action plans.
• Excellent written and verbal communication skills with the ability to produce clear, audit-ready documentation.
• Ability to work independently, manage competing priorities, and operate effectively within a highly regulated project environment.

Preferred Qualifications

• Experience supporting DeltaV systems in biologics, cell therapy, gene therapy, or small molecule pharmaceutical manufacturing.
• Familiarity with Gilead Sciences site standards, manufacturing systems, and CSV practices is a strong plus.
• Experience with DeltaV SIS (Safety Instrumented Systems) and integration with SIL-rated process safety systems.
• Knowledge of OPC-UA, OSIsoft PI Historian, or other plant data infrastructure and manufacturing execution system (MES) integrations.
• Emerson DeltaV certification or equivalent formal training documentation.
• Experience with cybersecurity frameworks applicable to OT/SCADA environments (NIST, IEC 62443).
• Familiarity with ISA/ISE Certified Automation Professional (CAP) or equivalent professional credential.

Education & Certifications

• Bachelor's degree in Chemical Engineering, Electrical Engineering, Instrumentation & Controls Engineering, or a closely related technical discipline required.

Working Conditions

Unless reasonable accommodations can be made, while performing this job the staff member shall:

• Endure prolonged periods of sitting or standing at a desk and working on a computer in an environmentally controlled home office or on-site environment.
• Operate other office and lab productivity machinery, such as a calculator, scanner, or printer.
• Frequently communicate with stakeholders via telephone, email, or instant message.
• Exchange accurate information in these situations.
• On-site presence at Gilead Sciences manufacturing facilities may be required; ability to travel as needed.

Compensation

Hourly Rate Range (W2): USD 85.00 - 100.00

The hourly rate range represents the anticipated low and high end of USDM's compensation range for this position. Actual hourly rates will vary and will be based on various factors, such as the candidate's qualifications, skills, competencies, and proficiency for the role. The compensation described above is subject to change and could be higher or lower than the range described based on market survey data or budget.

Full-time employees are eligible for health, vision, and dental insurance, life insurance, short and long-term disability, hospital indemnity, accident, and critical care coverage. Both full and part-time employees, who are at least 21 years of age, are eligible to participate in USDM's 401k plan. Full and part-time employees may be eligible for paid time off. All employees are eligible for USDM's rewards and recognition program.