Controls Engineer 3

BioTalent; Portsmouth (NH); On-site; USD 110,000 - 170,000; Full time

Job summary

BioTalent seeks a Senior Controls & Automation Engineer to lead and support manufacturing automation within a GMP environment. This role acts as the SME for controls, tech transfers, troubleshooting, and process improvements, collaborating across Manufacturing, Engineering, Quality, Validation, and Technical Operations to ensure reliable operation of automation systems.

The ideal candidate will have 5+ years of experience in regulated manufacturing, strong PLC/HMI/SCADA knowledge, and a proven

Qualifications

• Bachelor's degree in Electrical Engineering or related technical discipline.
• 5+ years of experience supporting automation and process control systems in a regulated manufacturing environment.
• Experience with pharmaceutical, biotechnology, life sciences, or GMP manufacturing operations.
• Strong knowledge of PLC, HMI, SCADA, and Historian systems.
• Experience with troubleshooting automation systems and supporting manufacturing operations.
• Knowledge of change control, CAPA, deviation management, and GMP documentation practices.
• Excellent analytical, problem-solving, and communication skills.

Responsibilities

• Lead planning, design, execution, and implementation of plant projects with complex equipment and significant process improvements.
• Serve as Controls Lead for technology transfer projects and integration of automation systems.
• Support commissioning, qualification, and startup activities for new equipment and systems.
• Drive continuous improvement focusing on reliability, performance, efficiency, and robustness.
• Provide SME support for design, operation, maintenance, and optimization of automation systems.

Skills

Analytical thinking

Problem solving

Communication

Cross-functional collaboration

GMP knowledge

Education

Bachelor's degree in Electrical Engineering

Tools

PLC

HMI/SCADA

OSIsoft PI Historian

DeltaV

Rockwell Automation

Siemens

Job description

The Senior Controls & Automation Engineer is responsible for leading and supporting manufacturing automation systems, process control improvements, and capital projects within a GMP manufacturing environment. This role serves as the Controls Subject Matter Expert (SME) for manufacturing operations, technical transfers, troubleshooting activities, process improvements, and regulatory inspections. The position works cross-functionally with Manufacturing, Engineering, Quality, Validation, and Technical Operations to ensure reliable operation of process automation systems while driving continuous improvement initiatives.

Key Responsibilities

Project Execution & Process Improvement

• Lead the planning, design, execution, and implementation of plant projects involving complex equipment modifications and significant process improvements.
• Serve as the Controls Lead for technology transfer projects, ensuring successful integration of automation systems into manufacturing operations.
• Support commissioning, qualification, and startup activities for new equipment and automation systems.
• Drive continuous improvement initiatives focused on reliability, performance, efficiency, and process robustness.

Automation & Controls Support

• Provide technical leadership and SME support for the design, operation, maintenance, and optimization of process automation systems and manufacturing equipment.
• Support resolution of equipment breakdowns, production issues, deviations, and product quality concerns related to automation systems.
• Conduct troubleshooting and root cause investigations for manufacturing process control systems, including PLCs, HMIs, SCADA systems, historians, and networked automation equipment.
• Analyze process and equipment performance using PI Historian data, control system trends, and automation analytics.
• Review, troubleshoot, and modify automation code and configurations as required.
• Participate in an on-call support rotation and provide technical support during off-hours as necessary.

Compliance, Quality & Change Management

• Initiate, manage, and support change controls throughout the full lifecycle, ensuring compliance with GMP and company requirements.
• Own and execute corrective and preventive actions (CAPAs) related to automation and controls systems.
• Support deviation investigations and implement corrective solutions.
• Review and approve SOPs, Functional Specifications, Work Instructions, and engineering documentation.
• Ensure all activities are performed in accordance with GMP, safety, quality, and regulatory requirements.

Cross-Functional Collaboration

• Represent the Controls function in Integrated Project Teams (IPT), Joint Project Teams (JPT), and cross-functional meetings.
• Collaborate with Manufacturing, Facilities, Quality, Validation, and Engineering teams to support operational excellence.
• Provide technical guidance and training on automation systems to manufacturing and support personnel.

Regulatory & Inspection Support

• Participate in internal audits, customer audits, and regulatory inspections as the Controls SME.
• Provide technical documentation and responses during audit and inspection activities.
• Ensure automation systems remain compliant with applicable regulatory requirements and data integrity standards.

Safety & Training

• Perform all work safely and follow Environmental Health & Safety (EHS) requirements.
• Complete all required training and maintain qualifications relevant to assigned responsibilities.
• Remain current on industry best practices, emerging technologies, and company procedures.

Required Qualifications

• Bachelor's degree in Electrical Engineering, Chemical Engineering, Automation Engineering, Computer Engineering, or related technical discipline.
• 5+ years of experience supporting automation and process control systems in a regulated manufacturing environment.
• Experience with pharmaceutical, biotechnology, life sciences, or GMP manufacturing operations.
• Strong knowledge of PLC, HMI, SCADA, and Historian systems.
• Experience with troubleshooting automation systems and supporting manufacturing operations.
• Knowledge of change control, CAPA, deviation management, and GMP documentation practices.
• Excellent analytical, problem-solving, and communication skills.

Preferred Qualifications

• Experience with DeltaV, Rockwell Automation, Siemens, or other distributed control systems.
• Experience with OSIsoft PI Historian and process data analytics.
• Knowledge of GAMP 5, 21 CFR Part 11, and computerized system validation (CSV).
• Project management experience supporting capital projects and technical transfers.
• Experience supporting regulatory inspections (FDA, EMA, MHRA, etc.).