Specialist, Manufacturing Automation

Position Overview

Our Digital Manufacturing Operations Team supporting our vibrant West Point site is seeking a Process Automation Engineer Specialist to join the team. This role provides automation system support and technical expertise to enable our Manufacturing Division in the reliable and compliant supply of quality vaccine products to customers and patients around the world. The position is responsible for problem resolution, implementation of process control and data collection techniques, and troubleshooting activities in compliance with SDLC, GMP, safety, and environmental requirements. The role works closely with Manufacturing, Quality, and Engineering organizations and supports a broad spectrum of automated systems within GMP manufacturing operations.

Key Functions

• Work independently and as a team member while demonstrating integrity, precision, accomplishment, motivation, ambition, and respect.
• Comply with global policies, procedures, guidelines, regulatory requirements, and current Good Manufacturing Practices (cGMP) in the execution of daily responsibilities.
• Provide automation system support and expertise to support the manufacture of quality vaccine products and achievement of site priorities.
• Serve as the technical owner for automation system components supporting manufacturing processes, including direct shop-floor support of manufacturing activities.
• Design, implement, test, and close change controls associated with automation-related corrective actions and continuous improvement initiatives.
• Build effective relationships with business partners and stakeholders to proactively identify and resolve technical issues.
• Lead or participate in investigations of automation incidents and system issues to prevent recurrence, including the development and implementation of corrective actions.
• Maintain awareness of emerging automation technologies and industry trends and provide recommendations for adoption where appropriate.
• Provide off-shift, weekend, evening, remote, or on-site automation support for 24/7 manufacturing operations as required.

Education

BS in Engineering, Computer Science or related field with 2 years of experience (GMP Manufacturing and/or Manufacturing Automation) or High School Diploma and 4 years of experience (GMP Manufacturing and/or Manufacturing Automation).

Experience, Skills & Knowledge Required

• Two (2) or more years of experience in process automation or a related field.
• Familiarity with Computer System Validation (CSV) requirements and regulated GxP environments.
• Knowledge of the ISA-88 Batch Standard.
• Strong communication and interpersonal skills with the ability to work effectively with colleagues across all organizational levels and with external stakeholders.

Preferred

• Experience in the pharmaceutical or biotechnology industry.
• Experience supporting aseptic processing and/or sterile manufacturing operations.
• Technical and operational expertise in areas such as: Distributed Control Systems (DCS), Programmable Logic Controllers (PLC), Supervisory Control and Data Acquisition (SCADA) systems, Human Machine Interface (HMI) systems, Network infrastructure, SQL databases, Manufacturing automation technologies.