Principal Engineer, Fill/ Finish

DSJ Global; North Dakota; On-site; USD 120,000 - 180,000; Full time

Job summary

DSJ Global is seeking a Principal Engineer, Fill/Finish for a regulated pharmaceutical manufacturer in the United States. You will develop and execute engineering strategies and serve as the technical expert for aseptic fill/finish operations, driving validation, contamination control, and equipment lifecycle management.

You will lead investigations, deviations, CAPAs, risk assessments, and PPQ strategies, support URS, FAT/SAT, IQ/OQ/PQ validations, and mentor junior engineers while

Qualifications

• Bachelor's degree in Engineering, Life Sciences, or related field.
• 5+ years in pharmaceutical/biotech manufacturing environments.
• Deep knowledge of aseptic processing, fill/finish, and cGMP.
• Experience supporting audits, validation, risk assessments, and investigations.

Responsibilities

• Lead aseptic fill/finish operations across clinical and commercial manufacturing.
• Drive process robustness, sterility assurance, contamination control, and efficiency.
• Provide technical support during inspections and audits.
• Oversee equipment implementation, optimization, and lifecycle management.
• Lead deviations, CAPAs, root cause analyses, and risk assessments.
• Support URS, FAT/SAT, IQ/OQ/PQ validations.
• Mentor junior engineers and provide technical leadership.

Skills

5+ years pharma engineering

aseptic processing

leadership & mentoring

Education

Bachelor's degree in Engineering or Life Sciences

Tools

Filling equipment

Isolators

Capping equipment

Inspection systems

Environmental monitoring tools

Job description

The Principal Engineer, Fill/Finish is responsible for developing and executing engineering strategies that support and expand aseptic drug product manufacturing capabilities. This role serves as the technical expert for fill/finish operations, driving process improvements, validation activities, contamination control strategies, and equipment lifecycle management within a regulated pharmaceutical manufacturing environment.

Key Responsibilities

• Serve as the subject matter expert for aseptic fill/finish operations supporting both drug substance and drug product manufacturing across clinical and commercial applications.
• Lead engineering initiatives focused on process robustness, sterility assurance, contamination control, and manufacturing efficiency.
• Provide technical support during regulatory inspections, customer audits, and compliance activities.
• Drive equipment implementation, optimization, and continuous improvement efforts for fill/finish manufacturing systems.
• Lead investigations, deviations, CAPAs, risk assessments, and root cause analyses related to manufacturing operations.
• Support the full equipment lifecycle, including URS development, FAT/SAT execution, commissioning, and IQ/OQ/PQ validation activities.
• Maintain and enhance sterility assurance programs, including:
• Aseptic Process Simulations (APS)
• Container Closure Integrity Testing (CCIT)
• Environmental Monitoring Performance Qualification (EMPQ)
• Develop and support Process Performance Qualification (PPQ) strategies and validation lifecycle management for filling operations.
• Mentor junior engineers and provide technical leadership across manufacturing and engineering teams.

Qualifications

• Bachelor's degree in Engineering, Life Sciences, or a related technical field.
• 5+ years of engineering experience within pharmaceutical, biotechnology, CDMO, or drug product manufacturing environments.
• Strong expertise in aseptic processing, fill/finish manufacturing, contamination control, and cGMP requirements.
• Working knowledge of regulatory standards and guidance, including USP and EU regulations related to sterile manufacturing.
• Experience supporting audits, inspections, validation programs, risk assessments, and quality investigations.
• Hands-on experience with fill/finish manufacturing equipment, including:
• Automated and semi-automated filling systems
• Isolators
• Capping equipment
• Inspection systems
• Secondary packaging lines

Travel & Physical Requirements

• Up to 25% travel, primarily domestic with occasional international travel.
• Ability to work in manufacturing environments and around production equipment.
• Must be able to stand, walk, bend, lift up to 50 pounds, and perform activities required in a regulated manufacturing facility.

Short Role Summary

Lead fill/finish engineering activities for sterile pharmaceutical manufacturing, providing technical expertise in aseptic processing, equipment validation, contamination control, and process improvement while supporting regulatory compliance and manufacturing growth initiatives.