Automation Project Leader for Life Sciences & Compliance

JC Automation Corp.

Northern (KY)

Hybrid

USD 110,000 - 170,000

Full time

14 days+

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Job summary

JC Automation Corp. (JCA) is seeking an Automation SME – Project Engineer to lead capital automation projects for pharmaceutical operations.

You will oversee design, procurement, installation, commissioning and start-up, coordinating internal teams and contractors to meet regulatory, safety, and quality objectives. Ideal candidates have 5+ years in pharmaceutical operations with process automation and CSV experience; bilingual English/Spanish is required.

Qualifications

Bachelor’s degree in Engineering, Computer Science, Information Systems, or related field.
Minimum five (5) years in pharmaceutical operations or manufacturing with project management experience, incl. 4+ years process automation and 2+ years CSV.
Experience with CFR/URS and DS/FRS development; PLC, data historians, MES, and validation knowledge.
Fully bilingual English/Spanish; strong communication and cross-functional collaboration.
Knowledge of cGMP, FDA/EMA regulations and 21 CFR Part 11; regulatory audit experience.

Responsibilities

Lead development, planning, and execution of Automation/IT capital projects.
Coordinate engineering, validation, IT, and vendors through all project phases.
Define scope, schedules, costs, risks, and deliverables; report milestones and risks.
Review vendor bids, create technical specs, support procurement; ensure regulatory compliance.