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 sites. This remote position offers a dynamic opportunity to oversee external sterile and aseptic filling operations while driving data-driven quality and process improvements. Operating within a cross-functional environment, you will bridge the gap between technical engineering, statistics, and external site execution to ensure our life-changing drug products are manufactured safely, compliistically, and efficiently.

Responsibilities

• Partner Oversight & Floor Support: Provide technical operations support for commercial Form/Fill manufacturing across external partner network sites, including on-site floor support for Person-In-Plant activities as needed.
• GMP Technical Authorship: Author, review, and maintain critical GMP technical documentation—including protocols, technical reports, and change control ownership—ensuring strict alignment with regulatory and quality standards.
• Continued Process Verification (CPV): Develop, execute, and maintain CPV plans, manage data sets, perform trend analyses, and author periodic process verification reports.
• Statistical Data Analysis: Extract and validate production, quality, and process control data from relevant GMP sources or approved data-trending systems.
• Process Visualization: Apply Statistical Process Control (SPC), capability analyses, and other mathematical methodologies to create clear data visualizations and summary metrics.
• Continuous Improvement: Contribute to proactive, data-driven process optimization initiatives and lead efforts to standardize manufacturing documentation.
• Project Management: Independently manage technical timelines, milestones, and deliverables to ensure external partner network deadlines are successfully met.

Education

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

Experience
Required:

• Minimum of 6 years of post-bachelor's degree experience within or supporting a GMP functional area (e.g., Operations, Technical Operations, Technology, or Engineering).
• Minimum of 3 years of direct experience supporting sterile / aseptic drug product filling processes (such as vials or syringes).
• Demonstrated experience applying statistical methodologies and process data analysis.
• Strong communication, teamwork, and independent project management skills.

Preferred:

• Direct experience working with advanced isolator filling technologies.

Additional Information

• Work Location: This is a fully remote position.
• Travel Requirements: Up to 25% travel is expected to support Person-In-Plant activities at various external partner network sites.