Sr. Project Engineer

We are seeking a highly motivated Technical Operations Contractor to support the commercial manufacturing of Drug Product (Form / Fill) across our External Partner network. In this role, you will be key in maintaining GMP technical documentation, managing change controls, and performing statistical data analyses to ensure process control, quality, and regulatory compliance. If you have a strong background in sterile or aseptic drug product filling and thrive in a collaborative, data-driven environment, this contract position offers an exciting opportunity to impact our global manufacturing operations.

Responsibilities

• Technical Documentation: Author, review, and maintain GMP technical documentation (including protocols, technical reports, and change control execution) in alignment with regulatory and quality standards.
• Process Verification: Develop and support Continued Process Verification (CPV) plans, data sets, trend analyses, and periodic reporting.
• Data Extraction & Validation: Pull and validate production, quality, and process control data directly from GMP sources or approved trending systems.
• Statistical Analysis & Visualization: Apply Statistical Process Control (SPC), capability analysis, and other analytical methods to generate summary metrics and visual reporting.
• Process Optimization: Contribute to continuous improvement initiatives, focusing on data-driven process optimization and documentation standardization.
• On-Site Floor Support: Provide on-site floor support as needed for Person-In-Plant (PIP) activities at External Partner manufacturing facilities.
• Project Management: Independently manage technical assignments, schedules, and deadlines to support business priorities.

Education

• Bachelor’s degree in Chemical/Biochemical Engineering, Pharmaceutical Science, Chemistry, Biology, or a related science/engineering field.

Experience

• 6+ years of post-bachelor's experience in a GMP functional area (or supporting a GMP area), such as Technical Operations, Operations, Technology, or Engineering.
• 3+ years of direct experience supporting sterile/aseptic drug product filling (e.g., vials, syringes, etc.).
• Demonstrated competency and hands-on experience with change control processes and technical document ownership.
• Experience applying statistical methods, SPC, and data analysis in a manufacturing setting.
• Preferred: Direct experience with isolator filling processes.

Additional Information

• Role Type: Technical Operations Contractor supporting External Partner commercial manufacturing.
• Travel Requirements: Travel may be required for Person-In-Plant support, not to exceed 25%.
• Core Competencies: Strong oral/written communication skills, excellent teamwork, and the ability to work independently to drive projects to schedule.