Job Title: DeltaV Engineer – Batch Design & Commissioning (Tech Transfer)

Location: On-site - Holly Springs, NC Job Type: Full-time / Contract Industry:

Pharmaceutical / Biotech Reports To: Automation Lead

Job Overview:
We are seeking an experienced DeltaV Engineer to support the batch design, configuration, and commissioning of an Emerson DeltaV Distributed Control System (DCS) for a technology transfer project from the customer’s Denmark site to their Holly Springs, NC facility. This role will involve configuring batch control strategies, ensuring compliance with ISA-88, supporting validation activities, and commissioning the system for GMP production.

Key Responsibilities:

Batch Design & Configuration

Lead the design, development, and configuration of DeltaV batch processes, ensuring alignment with the existing system in Denmark.

Implement ISA-88 compliant batch structures, including Phase, Unit, and Equipment Modules for seamless tech transfer.

Develop and test recipe management strategies, interlocks, and alarms for biopharmaceutical manufacturing processes.

Integrate DeltaV with upstream/downstream processing equipment, utilities, and MES systems.

Commissioning & Tech Transfer Support

Collaborate with automation, process engineering, and validation teams to ensure a smooth technology transfer to the Holly Springs site.

Conduct system testing, loop checks, and functional verification of DeltaV batch sequences.

Support Factory Acceptance Testing (FAT), Site Acceptance Testing (SAT), and commissioning activities.

Assist in debugging and troubleshooting control strategies to ensure process stability and compliance.

Validation & Compliance

Author, review, and execute IQ/OQ/PQ protocols for DeltaV batch automation.

Ensure all GMP, 21 CFR Part 11, GAMP 5, and data integrity requirements are met.

Develop and maintain functional design specifications (FDS), user requirements (URS), and standard operating procedures (SOPs) for automation systems.

Qualifications & Experience:

Bachelor’s degree in Engineering (Chemical, Electrical, Automation, or related field).

10+ years of hands-on experience in Emerson DeltaV batch configuration, commissioning, and validation in a biopharmaceutical or GMP-regulated environment.

Strong knowledge of ISA-88 batch processing, recipe management, and equipment phase design.

Experience with DeltaV module configuration, SFCs, and alarm management.

Hands-on experience with loop checks, troubleshooting I/O, and commissioning batch sequences.

Working knowledge of cGMP, GAMP 5, and FDA 21 CFR Part 11 compliance.

Ability to read and interpret P&IDs, process flow diagrams (PFDs), and electrical schematics.

Excellent communication and documentation skills to support tech transfer coordination.
Preferred Qualifications:

DeltaV certifications or formal training from Emerson.

Experience with DeltaV Electronic Marshalling (CHARM I/O) and DeltaV Historian.

Familiarity with virtualized environments (VMware), MES integration, and SQL reporting.

Previous experience in a tech transfer project within a biopharma facility.