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Automation Engineer -- GMP Pharmaceutical Sterile Injectable manufacturing

Interact Engineering LLC
Whippany, NJ

Quick Apply

Job Details

Temporary | Full-time
$75 an hour
3 days ago

Qualifications

Human-machine interface (HMI) systems
FDA 21 CFR Part 11
Electrical engineering
Manufacturing facility experience
Bachelor's degree
Pharmaceutical company experience
Supervisory control and data acquisition (SCADA)
Biomedical regulatory compliance
Manufacturing
Regulatory compliance analysis
Packaging equipment
Pharmaceutical manufacturing facility experience
SCADA system design

Full Job Description

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:

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: In person

Quick Apply

Refine Your Search

key logic systems jobs in new york, ny

Automation Engineer -- GMP Pharmaceutical Sterile Injectable manufacturing

Workfront System Administrator Associate

Millwork CNC Operator

Senior Vulnerability Researcher (Cloud & Containers)

Property Accounting Expert (SME)

Senior Vulnerability Researcher (5G & Protocol Security)

Software Engineer II - Infrastructure

HR Data Analyst

Talent & Operations

AI Agent Product Manager

Staff Data Analyst, Healthcare

Lead, Data Governance

Software Engineer, Product

Director, Quality Programs

Director, Implementation Services

Senior NetSuite Systems Analyst

SVP, People Operations

Fullstack Engineer

Aladdin Integration Data Analyst

VP, Reasoning Systems

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