DeltaV Automation Area Lead
Automation Area Lead - Pharmaceutical Manufacturing
Role Overview
The Automation Area Lead will provide technical and project leadership for automation activities within a designated manufacturing area. This role is responsible for overseeing control strategy development, system design, documentation review, testing support, and coordination with system integrators, ensuring solutions are compliant with GMP and ISA‑88 batch standards.
This position requires approximately 20% travel (around 4 days per month) to support project and site activities.
Key Responsibilities
Automation Area Leadership
- Provide automation leadership for a defined manufacturing area.
- Act as the primary technical interface between internal stakeholders and system integrators.
- Support on‑site activities as required, including FAT, SAT, commissioning, and startup support.
Design & Documentation
- Review P&IDs and control strategies for accuracy, compliance, and alignment with process requirements.
- Review User Requirement Specifications (URS) developed by others.
- Draft Functional Specifications (FS) for assigned systems.
- Review and approve final Functional Specifications provided by system integrators.
- Develop, review, and approve:
- Functional Requirement Specifications (FRS)
- Design Specifications
- Control system code
Testing & Validation
- Support testing strategies including FAT, SAT, and commissioning activities.
- Review and approve test documentation and execution results.
- Support computer system validation activities in a GMP‑regulated environment.
System Architecture & Software
- Define and maintain the ISA‑88 software structure.
- Identify and document required software components to be created, replicated, or modified (including gaps within existing standard libraries).
- Ensure software design aligns with batch control standards and site automation frameworks.
Process Equipment Supported
The Automation Area Lead will support automation systems associated with the following process equipment and utilities:
- Reactors
- Crystallizers
- Agitated Filter Dryers (AFD)
- Head Tanks
- Common Utilities
- Process Vacuum Systems
- Process Scrubbers
- Drum Unloading Stations
- Wash Solvent Tanks
- Condensate Collection Tanks
- Process Vent and Knockout Tanks
- Clean‑in‑Place (CIP) Systems
- Miscellaneous process equipment as required
Required Qualifications & Experience
- Bachelor's degree in Engineering or higher.
- 8+ years of Automation Engineering experience.
- Minimum of 3 years supporting chemical unit operations.
- Pharmaceutical manufacturing experience.
- Strong knowledge of batch control systems in accordance with ISA‑88 standards.
- Experience delivering large capital or automation projects.
- Solid understanding of GMP requirements.
- Hands‑on experience with computer system validation.
- Excellent written and verbal communication skills, with the ability to collaborate across both technical and non‑technical teams.
- Willingness to travel approximately 20% to support project and site needs.
FAQs
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