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Manufacturing Engineer - Pharma
Manufacturing Engineer - PharmaPharmEng Technology • Raleigh, NC, US
Manufacturing Engineer - Pharma

Manufacturing Engineer - Pharma

PharmEng Technology • Raleigh, NC, US
1 day ago
Job type
  • Full-time
Job description

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About the job : Manufacturing Engineer - Pharma

Principal Manufacturing Engineer Fill / Finish (24 / 7 Operations Support)

Full-Time | On-Site | Rotational 24 / 7 Coverage

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.

    Additional Details

  • Seniority level : Mid-Senior level
  • Employment type : Full-time
  • Job function : Engineering and Information Technology
  • Industries : Pharmaceutical Manufacturing

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