Manufacturing Maintenance and Automation Specialist

Job Description:

The Maintenance Specialist will be responsible for ensuring the safety, quality, and availability of pharmaceutical manufacturing equipment. This includes clinical/commercial manufacturing equipment ranging from semi-automated to automated and large-scale operations.

The Specialist will utilize industry-standard and novel equipment, processes, and methodologies to install, repair, and maintain equipment. They will develop, maintain, and optimize calibration and PM cycles for all manufacturing equipment.

This role requires daily tactical responsibilities leading up to strategic decisions and involves providing technical leadership to the manufacturing team and management.

• Maintenance Leadership: Provide technical direction to the manufacturing team and management.
• Maintenance Execution: Lead and execute maintenance, both repair and preventative.
• Best Practices Development: Develop and implement best practices for maintenance and service in accordance with manufacturer recommendations.
• Business Improvement: Develop, propose, and implement vision, strategy, policies, processes, and procedures to improve business performance.
• Scale-up and Commercialization: Lead scale-up and commercialization efforts.
• Root Cause Investigations: Lead root cause investigations.
• Lifecycle Management: Lead life-cycle management efforts.
• Technical Analysis: Lead and execute technical analyses, including statistical analysis and tolerance analysis.
• Documentation: Document studies and author documents per US FDA, EMA, MHRA, and other global health authority requirements.
• Third-party Interface: Interface and lead activities with third-party contract research, development, and manufacturing organizations.
• Manufacturing Strategy: Ensure that manufacturing strategies and processes are in place to meet business objectives and operational needs.
• Risk Mitigation and Opportunity Development: Proactively evaluate challenges faced by the business and take actions to mitigate risks and develop opportunities.
• Device Design History Files (DHF): Contribute towards maintaining device design history files (DHF).
• Standard Operating Procedures (SOPs): Document standard operating procedures (SOPs) for design controls and manufacturing in the context of pharmaceutical drug-device combination products.
• Business Strategy and Annual Budget: Contribute towards overall business strategy and annual budget process.
• Project Updates and Reporting: Provide project updates/reporting through program governance.
• Inter-site Best Practices: Support organizational/departmental initiatives, including technology transfer, process validation, etc.
• Project Strategy and Milestones: Execute project strategy, priorities, and milestones ensuring visibility and accountability.

Qualification Requirements:

• A B.S. in Mechanical Engineering, Electrical Engineering, Robotics, or related discipline with 5 to 7 years' experience, or A.S. with 7 to 10 years' experience in a pharmaceutical or related field.
• Experience with cGMP manufacturing in the context of pharmaceutical clinical and commercial manufacturing is required.
• Must possess expert knowledge and experience with manufacturing and aseptic filling processes, including manual, semi-automated, and/or commercial scale automated processes.
• Experience with CompactLogix (PLC), AVEA (formerly Wonderware), Windows 10 Enterprise IoT LTSB, PMS (Particle Monitoring Systems) software packages is highly preferred.
• Proven automation experience with increased levels of responsibility.
• Knowledge of GAMP lifecycle and quality management processes employed in the pharmaceutical sector.
• Must possess knowledge of various pharmaceutical processing equipment design, optimization, qualification, and life-cycle management.
• Must possess knowledge of regulations and standards including US 21 CFR Part 820, 821.
• Experience with DCS and/or PLC software design.
• Strong English language skills, including writing ability and oral communication.
• Demonstrates good judgment as well as cultural, social, and environmental awareness.