Process Engineer/Senior Process Engineer

Position Summary

The Senior / Principal Process Engineer will join our Technical Services team as a full-time Drug Product Manufacturing Subject Matter Expert (SME), supporting biopharmaceutical clients across the product lifecycle from process development, scale-up, and technology transfer through process validation and commercial manufacturing lifecycle management. In this role, you will bring hands-on sterile drug product manufacturing expertise to lead process and equipment readiness activities, gap assessments, and process engineering or manufacturing science engagements.

Responsibilities

• Serve as a Drug Product Manufacturing SME, providing technical expertise in aseptic processing, including formulation/compounding, sterile filtration, filling into drug product container closure systems (e.g., vials, syringes, cartridges), lyophilization, capping/crimping/stoppering, and visual inspection.
• Act as Functional Lead for a team of process engineers, scientists, and specialist resources: assign and prioritize work, provide technical direction and coaching, and ensure deliverables meet quality, schedule, and scope expectations.
• Perform technical and quality review of deliverables for technical accuracy, Good Manufacturing Practice (GMP) regulatory compliance, Good Documentation Practices (GDP), and consistency with global quality standards.
• Author and revise procedures and supporting documents for drug product manufacturing and related operations (e.g., aseptic gowning and behaviors, line clearance, equipment operation and cleaning, line change-over, automation, alarm management, environmental monitoring interfaces, visual inspection, and material flow).
• Conduct gap assessments of existing documentation (e.g., manufacturing records, technical development reports, global/corporate procedures) and identify areas of improvement/remediation needed.
• Partner with client functional leaders, SMEs, and Quality to gather process requirements, facilitate document reviews, adjudicate comments, and drive documents through digital review and approval workflows.
• Support project governance by tracking deliverable status, identifying and escalating risks, and reporting progress to Kymanox project managers and client stakeholders.

Educational Background

The ideal candidate will have a Bachelor's degree in an engineering or science-related field such as Chemical Engineering, Biomedical Engineering, Mechanical Engineering, Biology, Chemistry, or Biochemistry. An advanced degree (e.g., Master of Science, Master of Engineering) is preferred.

Experience

• 7–15 years (Senior) or 15+ years (Principal) of experience in the development or manufacturing of biopharmaceuticals, with a significant focus on drug product/sterile fill-finish manufacturing.
• Hands-on experience with drug product formulation/compounding, sterile filtration, filling, lyophilization, capping/crimping/stoppering, and visual inspection.
• Experience with isolator and/or RABS technology preferred.
• Demonstrated experience authoring and reviewing GMP documentation such as manufacturing records, SOPs, work instructions, and protocols, including serving as a technical or quality reviewer.
• Experience leading or coordinating the work of others (e.g., technical lead, functional lead, or team lead) on cross-functional projects.
• Strong knowledge of global GMP regulations, contamination control strategies, and core quality management system elements (document control, change control, and training).
• Experience with new facility start-up, commissioning and qualification, or technology transfer strongly preferred.
• Experience with electronic document management platforms and electronic batch record (eBR/MES) environments preferred.
• Experience with MS Office products (Outlook, Excel, PowerPoint, Word) strongly preferred.

Desired Aptitude and Skill Set

• Excellent technical writing and documentation skills
• Strong problem-solving abilities with proven analytical thinking
• Effective communication and interpersonal skills with ability to work across departments and with client stakeholders
• Detail-oriented
• Strong organizational skills and verbal/written communication skills
• Highly motivated self-starter with a sense of ownership and willingness to learn
• Thrive in a fast-paced, growing, and dynamic work environment
• Ability to form partnerships with internal and client stakeholders
• Seasoned soft skills (i.e., high EQ)
• Comfortable leading, delegating to, and developing team members
• Technology savvy

Travel

Regular local travel to client facilities in the Research Triangle Park, NC area is required. Periodic travel to client facilities in other regions may be required as needed.