An opportunity is available for an experienced Principal Manufacturing Engineer to join a 24/7 technical support team at a leading vaccine manufacturing facility. This role is responsible for providing high-level technical support to Fill/Finish operations, ensuring process reliability, equipment uptime, and compliance with GMP standards.

Position Overview

As a key member of the 24/7 Manufacturing Support team, the Principal Manufacturing Engineer will serve as the first line of response for operational and equipment-related issues on the production floor. This individual will play a critical role in maintaining continuous operations, supporting investigations, driving process improvements, and mentoring junior staff.

Key Responsibilities

• Provide real-time technical support for Fill/Finish production, including troubleshooting of equipment and automation systems.
• Lead and support the resolution of complex technical issues to minimize downtime and ensure product quality is maintained .
• Author and revise manufacturing documentation, including SOPs, batch records, and work instructions.
• Manage and contribute to maintaining quality records, including deviations, incidents, CAPAs, and change controls.
• Support investigations related to process deviations, equipment performance, and adverse trends.
• Contribute to site-wide process improvement initiatives that enhance safety, efficiency, and reliability.
• Provide support for manufacturing systems, including GLIMS, SAP, and other electronic systems.
• Mentor and coach junior engineering staff, contributing to knowledge transfer across teams.

Qualifications

• Bachelor's degree in Engineering or a related scientific discipline, or equivalent industry experience.
• Minimum of 5 years of experience in pharmaceutical or biotech manufacturing.
• Strong technical knowledge of Fill/Finish operations in a GMP-regulated environment.
• Demonstrated experience in equipment troubleshooting, automation systems, and process support.
• Proficiency in handling documentation and quality systems related to regulated manufacturing.
• High attention to detail, strong problem-solving abilities, and the ability to work independently within a fast-paced, shift-based environment.

This is a key position within a high-impact team supporting essential vaccine production. Candidates must be comfortable working in a rotating 24/7 support model and collaborating across functions to maintain manufacturing performance.