Job Description
Automation Engineer – 2nd Shift
Sterile Injectable Manufacturing | Whippany, New Jersey
Position Summary
Halo Pharmaceutical, a leading North American CDMO, is seeking an experienced Automation Engineer – 2nd Shift to support, maintain, and continuously improve the automated control systems that underpin our aseptic fill-finish operations.
This role is critical to ensuring the reliable, compliant, and high-uptime operation of our Groninger UFVN FlexFill filling line, SKAN isolator, and associated process control infrastructure during the afternoon/evening shift. The successful candidate will bring hands-on expertise in pharmaceutical automation, PLC/SCADA/HMI systems, 21 CFR Part 11 compliance, and GAMP 5-based computer system validation (CSV), and will serve as the primary automation technical resource on-shift.
Key Responsibilities
Automation System Operations & Support
- Serve as the primary 2nd shift automation technical resource for the sterile injectable manufacturing suite, including the Groninger UFVN FlexFill filling line, SKAN isolator, and all integrated process control systems.
- Monitor, troubleshoot, and resolve PLC, SCADA, HMI, and DCS alarms and faults in real time to minimize production downtime and maintain aseptic integrity.
- Coordinate with 1st shift Automation Engineers at shift handover to ensure continuity of ongoing issues, open work orders, and in-progress qualifications.
- Interface with the Manufacturing, Validation, and Quality teams on shift to resolve automation-related production deviations and support timely deviation documentation.
- Respond to and manage automation-related equipment stoppages, line clearances, and restart sequences in accordance with approved SOPs and batch record instructions.
Maintenance, Calibration & Change Control
- Perform scheduled and corrective maintenance on automated control systems, sensors, actuators, servo drives, vision inspection systems, and reject handling mechanisms.
- Execute and document instrumentation calibrations and verifications (e.g., flow meters, pressure transmitters, fill weight check-weighers) in compliance with cGMP requirements.
- Initiate and support change control activities for automation software modifications, parameter adjustments, or hardware replacements; ensure all changes are captured in the site change management system.
Computer System Validation (CSV) & 21 CFR Part 11
- Support the execution of CSV activities for automated filling line systems, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) protocols.
- Ensure all automated systems operate in compliance with 21 CFR Part 11 requirements, including audit trail integrity, electronic signature controls, and data backup verification.
- Participate in audit trail review and periodic review of computerized systems to assess continued compliance with validated state; identify and escalate out-of-compliance conditions.
- Contribute to the authoring and review of User Requirements Specifications (URS), Functional Specifications (FS), and validation summary reports for automation systems.
Equipment Qualification & IQ/OQ/PQ Interface
- Interface with the Validation team on 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:
Experience:
- PLC programming, SCADA/HMI configuration: 3 years (Required)
- PLC, SCADA, Machine Control Systems: 3 years (Required)
Location:
- Whippany, NJ 07981 (Preferred)
Work Location: In person
