IQ/OQ/PQ

activities for the sterile filling line, SKAN isolator, and associated utilities (compressed air, nitrogen, WFI, clean steam) as they relate to automation readiness and system acceptance. Execute qualification test scripts and document results for automated control system verification, including interlock testing, alarm functionality, and fail-safe logic verification. Continuous Improvement & Cross-Functional Collaboration Identify and champion automation-driven continuous improvement initiatives to enhance line efficiency, reduce manual interventions, and improve overall equipment effectiveness (OEE). Collaborate with Manufacturing, Quality Assurance, Validation, and Engineering teams to integrate automation requirements into new product introductions and technology transfers. Support investigation and root cause analysis for automation-related deviations, OOS events, and equipment failures; author or contribute to CAPA documentation as appropriate. Participate in cross-shift and cross-functional technical meetings to share automation performance metrics and escalate systemic issues. Required Qualifications Education Bachelor of Science in Electrical Engineering, Mechanical Engineering, Chemical Engineering, Computer Science, or a related technical discipline. Experience Minimum 3-5 years of pharmaceutical automation experience in a cGMP manufacturing environment, with direct hands-on experience in PLC programming, SCADA/HMI configuration, and automated filling or packaging equipment. Regulatory Knowledge Working knowledge of

FDA 21 CFR

Parts 210/211, 21 CFR Part 11 (electronic records and signatures), EU GMP Annex 11, GAMP 5, and ISA-88 batch control standards. Technical Skills Proficiency with major PLC platforms (Siemens, Allen-Bradley/Rockwell), SCADA systems (Wonderware, FactoryTalk, or equivalent), and HMI development tools. Experience with servo/motion control systems, vision inspection integration, and network-level diagnostics preferred. Preferred Qualifications Experience with high-speed fill-finish automation platforms. Familiarity with isolator control systems and related H2O2 bio-decontamination cycle automation. Background in CDMO environments with multi-product aseptic manufacturing portfolios requiring frequent changeovers and recipe management. Knowledge of

ISA/IEC 62443

industrial cybersecurity standards as applied to pharmaceutical manufacturing control systems. ISA Certified Automation Professional (CAP) or equivalent industry certification preferred. Experience with MES (Manufacturing Execution System) integration and electronic batch record (EBR) systems. Core Competencies Technical Mastery Deep expertise in pharmaceutical automation systems, control architecture, and fill-finish equipment integration in a cGMP sterile manufacturing environment. Attention to Detail Meticulous in change control documentation, GMP record-keeping, system configuration baselines, and calibration data integrity compliance. Problem Solving Skilled in real-time fault diagnosis and systematic root cause analysis for automation failures, production deviations, and control system anomalies, including CAPA development. Collaboration Works effectively across Manufacturing, QA, Validation, Engineering, and client teams in a fast-paced CDMO environment; excels in cross-shift communication and knowledge transfer. Communication Clear and concise technical writing and verbal communication skills, including the ability to document automation system events, deviations, and validation data for regulatory agencies and clients.

Pay:

$75.00 per hour Application Question(s): Do you have hands-on experience in PLC programming, SCADA/HMI configuration?

Education:

Bachelor's (Required)

Experience:

PLC programming, SCADA/HMI configuration: 3 years (Required)

PLC, SCADA, Machine Control Systems:

3 years (Required)

Location:

Whippany, NJ 07981 (Preferred)

Work Location:

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Automation Engineer -- GMP Pharmaceutical Sterile Injectable manufacturing