Overview
On Site
Full Time
Skills
GMP
Process Control
Root Cause Analysis
Collaboration
Process Engineering
Quality Assurance
Technical Writing
Functional Design
FDS
System Requirements
Specification Gathering
MES
Hardening
Mentorship
Change Management
Regulatory Compliance
Pharmaceutics
Manufacturing
Job Details
Roles & Responsibilities:
- Lead design, configuration, and commissioning of DeltaV and Client-X automation systems for GMP-critical manufacturing equipment and process controls.
- Support change controls, deviations, and CAPAs involving DeltaV and Client-X logic, batch strategies, and alarm configuration in collaboration with QA and Validation.
- Develop and modify control modules, phases, and equipment modules within DeltaV in alignment with S88 batch architecture standards.
- Provide hands-on troubleshooting and root cause analysis for DeltaV and Client-X system issues during routine operations and project start-up phases.
- Collaborate with cross-functional teams (Process Engineering, QA, Validation, and Manufacturing) to align automation changes with business needs.
- uthor and review technical documentation including Functional Design Specs (FDS), software requirement specs, and test protocols.
- Interface with Client-X MES and data historians to ensure integration and data continuity across digital systems.
- Participate in system upgrades, patching, and security hardening activities to maintain compliance and cyber-resilience of DeltaV and Client-X environments.
- Train and mentor site engineers/operators on Delta and Client-X operations, change management, and system maintenance best practices.
- Ensure automation compliance
- 3-5 years of automation experience within pharmaceutical or biopharmaceutical manufacturing.
- Experience with Client-X and Delta highly preferred
- Experience working within FDA remediation projects
- Bachelor's degree in engineering or equivalent discipline.
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