Manufacturing Automation Engineer

Responsibilities

• Support manufacturing operations through technical assistance for manufacturing and process automation systems.
• Ensure instrumentation and automation systems are designed and operated to meet production needs.
• Plan and execute plant projects involving complex equipment changes and significant process improvements.
• Serve as the Controls lead for technology transfer activities.
• Support the resolution of equipment breakdowns and quality issues in manufacturing suites.
• Provide subject matter expertise to Manufacturing and other departments for the design and operation of process automation equipment.
• Troubleshoot manufacturing equipment and process automation systems, including PI data analysis and code review/troubleshooting, during business hours and as part of an on-call rotation.
• Perform all work safely and complete all required training.
• Participate in IPT/JPT and other meetings as the Controls representative.
• Participate in audits and inspections as the Controls SME when required.
• Own and execute CAPA actions.
• Initiate change controls and participate in all aspects of the change control process.
• Review SOPs, Functional Specifications, and work instructions.
• Maintain all assigned training requirements.
• Perform other duties as assigned.
• May provide direction to 1–2 contractors working on projects within the group.
• May monitor project timelines and budgets to ensure deliverables are completed on time and within budget.

Requirements

• Bachelor's degree in an applicable Engineering field or Computer Science.
• 5–10 years of experience in Pharmaceutical, Biotechnology, or equivalent industrial automation.
• Supervisory and/or project management experience preferred.
• Experience supporting manufacturing and process automation systems.
• Knowledge of instrumentation, automation, and process control systems.
• Experience with troubleshooting manufacturing equipment and automation systems.
• Experience with PI data analysis and code review/troubleshooting.
• Experience with CAPA and Change Control processes.
• Ability to review SOPs, Functional Specifications, and work instructions.
• Strong critical thinking and logical problem-solving skills.
• Proficiency with Microsoft Office Suite, including Outlook, Word, and Excel.
• Ability to prioritize multiple assignments and lead work to successful completion.
• Strong collaboration and communication skills with cross-functional teams.
• Ability to manage internal and external customer relationships professionally.
• Demonstrated integrity, accountability, and commitment to continuous improvement.
• Ability to promote change and support the development of team members.
• Knowledge of cGMP requirements and compliance in API manufacturing.
• Commitment to workplace safety, health and safety procedures, and regulatory compliance.
• Able to work safely with manufacturing equipment and recognize potential hazards.