Overview
Skills
Job Details
Title: Delta V design Lead
location: Indiana - Onsite
Duration: 6+ to Long Term
Role Purpose
The Automation Lead is responsible for delivering the control system design and implementation for a defined manufacturing area within a large-scale pharmaceutical project. This role ensures the automation solution meets program standards, user requirements, and GMP regulations, while working in close partnership with system integrators, process engineers, quality, operations, and the wider project team.
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Core Responsibilities
Serve as the technical owner for automation in an assigned manufacturing area.
Define and maintain the S88 batch structure, control modules, and equipment lists for the area.
Draft and review functional design specifications (FDS) and collaborate with system integrators to finalize deliverables.
Participate in P&ID, control strategy, and design reviews to ensure alignment with process needs and program philosophy.
Ensure all automation documentation (URS, FRS, FDS, recipes, phases, control strategies, etc.) is complete, consistent, and compliant.
Develop parameter and recipe specifications and oversee implementation by system integrators.
Provide timely responses to technical queries and drive resolution of automation issues.
Identify and manage risks, remediation activities, and software change impacts specific to the assigned area.
Log, track, and close out issues in the project issue tracker post-software acceptance.
Report progress, challenges, and resource needs to the Automation Technical Lead.
Ensure all activities comply with GMP requirements, regulatory standards, and site training obligations.
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Qualifications & Experience
BS in Engineering or equivalent experience.
8+ years of automation experience in the pharmaceutical industry (API/bulk manufacturing strongly preferred).
Proven track record delivering automation for large-scale pharmaceutical projects or programs.
Minimum 5 years' hands-on experience with DeltaV Batch DCS.
Familiarity with Allen-Bradley PLCs (preferred).
Strong understanding of GMPs, regulatory requirements, and computer system validation principles.
Excellent communication skills, with the ability to explain technical details to both technical and non-technical audiences.
Demonstrated teamwork and cross-functional collaboration skills in fast-paced project environments