PharmEng Technology
Manufacturing Engineer - Pharma
PharmEng Technology, Raleigh, North Carolina, United States, 27601
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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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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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