Senior Controls Engineer

S4 Analytics LLC; New York (NY); On-site; USD 120,000 - 170,000; Full time

Job summary

A leading pharmaceutical company is seeking a Senior Controls Engineer to support aseptic sterile fill/finish operations in New York. The role focuses on OT systems, automation, and controls engineering within a GMP-regulated environment. Key responsibilities include hands-on support for OT controls, troubleshooting PLC/HMI systems, and leading controls engineering efforts for compliance initiatives. The ideal candidate has over 10 years of experience and a strong background in pharmaceutical manufacturing processes.

Qualifications

• 10+ years of experience in Controls / Automation Engineering.
• Strong hands-on experience with PLC/HMI systems, preferably Rockwell Allen-Bradley.
• Experience working in pharmaceutical GMP/FDA-regulated environments.
• Experience working in pharmaceutical GMP/FDA-regulated environments.
• Solid understanding of GAMP5 and Data Integrity principles.
• Excellent troubleshooting, problem-solving, and cross-functional collaboration skills.

Responsibilities

• Provide hands‑on support for OT controls and automation systems.
• Develop, program, and troubleshoot PLC/HMI systems.
• Lead controls engineering efforts for capital projects.
• Support GMP/FDA-regulated manufacturing and validation activities
• Collaborate with Maintenance, QA, Validation, and external vendors to ensure system performance and compliance
• Participate in system upgrades, troubleshooting, and continuous improvement initiatives
• Ensure adherence to GAMP5 guidelines and data integrity standards

Skills

PLC/HMI systems troubleshooting

Automation engineering

Cross-functional collaboration

Problem-solving

GMP/FDA compliance

Education

Bachelor’s degree in Engineering or related field

Tools

FactoryTalk

Wonderware

iFix

Proficy

Rockwell Allen-Bradley

Job description

We are hiring a Senior Controls Engineer to support aseptic sterile fill/finish operations at a rapidly growing pharmaceutical CDMO. This role will focus on OT systems, automation, and controls engineering, ensuring reliable and compliant manufacturing processes in a GMP-regulated environment.

Key Responsibilities

• Provide hands‑on support for OT controls and automation systems within manufacturing environments
• Develop, program, and troubleshoot PLC/HMI systems (Rockwell Allen‑Bradley preferred)
• Lead controls engineering efforts for capital projects and compliance initiatives
• Support GMP/FDA-regulated manufacturing and validation activities
• Collaborate with Maintenance, QA, Validation, and external vendors to ensure system performance and compliance
• Participate in system upgrades, troubleshooting, and continuous improvement initiatives
• Ensure adherence to GAMP5 guidelines and data integrity standards

Required Qualifications

• Bachelor’s degree in Engineering or a related field
• 10+ years of experience in Controls / Automation Engineering
• Strong hands‑on experience with PLC/HMI systems (Rockwell Allen‑Bradley)
• Experience working in pharmaceutical GMP/FDA-regulated environments
• Solid understanding of GAMP5 and Data Integrity principles
• Excellent troubleshooting, problem‑solving, and cross‑functional collaboration skills

Nice to Have

• Experience with FactoryTalk, Wonderware, iFix, or Proficy
• Exposure to aseptic sterile filling and lyophilization processes
• Experience in CDMO or high‑volume pharmaceutical manufacturing environments