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Automation Engineer – Drawing Remediation & QS Alignment

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Job Description - Automation Engineer – Drawing Remediation & QS Alignment


Automation Engineer – Drawing Remediation & QS Alignment

Contract: 12-18 months duration

Location: Kenosha County, WI – Onsite On-site, Kenosha County, WI.

Work: Standard business hours with occasional coordination needs outside core hours.




Role Summary

ASI is seeking an experienced Automation Engineer to support drawing remediation and LQS/GQS alignment activities at the Kenosha County site, a recently acquired facility transitioning from legacy pharmaceutical systems. This role is embedded with the site Automation team and is responsible for bringing automation-related documentation, drawings, and system configurations into full compliance with client’s quality standards.




Key Responsibilities

•     Perform gap assessment of existing BAS/DCS drawings against Quality Standards (QS) and Global Quality Standards (GQS)

•     Execute redline markups and formal drawing revisions for automation-related P&IDs, loop diagrams, and instrument indexes

•     Collaborate with Automation and Facilities engineering leads to prioritize remediation sequence aligned with Phase 2 system acceptance milestones

•     Support BAS/DCS alignment activities including configuration review, alarm rationalization, and documentation updates

•     Coordinate with the Engineering Technical Writer to route revised documents through GMP document control (Veeva/MasterControl)

•     Participate in QBMS alarm coverage handoff planning as the long-term automated solution is developed

•     Contribute to change control packages (MOCs) as required for documented system changes






Requirements

Required Qualifications

•     3–7+ years of automation engineering experience in a GMP pharmaceutical or biotech manufacturing environment

•     Hands-on experience with BAS/DCS platforms — Rockwell, Siemens Desigo CC, or equivalent

•     Proficiency in reading and revising engineering drawings: loop sheets, P&IDs, instrument indexes, wiring diagrams

•     Familiarity with GMP documentation requirements and change control procedures

•     Experience with drawing remediation, document lifecycle management, or legacy system integration projects




Preferred Qualifications

•     Familiarity with Quality Standards (QS) or equivalent large-pharma quality frameworks

•     Experience with Veeva QualityDocs or MasterControl for GMP document routing

•     Exposure to site acquisition / system integration projects

•     CSIA certification or equivalent automation professional credential

 







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