Process Engineer/Senior Process Engineer

Kymanox•Morrisville, NC

12d

About The Position

The Senior / Principal Process Engineer will join Kymanox’s Technical Services team as a full-time Drug Product Manufacturing Subject Matter Expert, supporting biopharmaceutical clients throughout the product lifecycle, from process development, scale-up, and technology transfer through process validation and commercial manufacturing lifecycle management. The role brings hands-on sterile drug product manufacturing expertise to process and equipment readiness activities, gap assessments, and process engineering or manufacturing science engagements. Work may include assessing, authoring, and technically or qualitatively reviewing manufacturing procedures, plans, protocols, work instructions, forms, and associated training content. The position may provide day-to-day direction and leadership for a cross-functional team of process engineers, scientists, and specialist resources. The successful candidate will partner with client functional leaders and executive stakeholders, as well as Kymanox functional leads, to deliver technically accurate and compliant solutions. Title and level will be commensurate with skill set and experience. Regular local travel to client facilities in the Research Triangle Park, North Carolina area is required; periodic travel to client facilities in other regions may be required. The role may evolve over time, with additional responsibilities and opportunities for advancement within the role or other organizational functions. Base salary is commensurate with experience, qualifications, interview assessment, and market conditions. The role is eligible for an incentive program after six months of outstanding work.

Requirements

Bachelor’s degree in an engineering or science-related field, such as Chemical Engineering, Biomedical Engineering, Mechanical Engineering, Biology, Chemistry, or Biochemistry.
7–15 years of experience for the Senior level or 15+ years for the Principal level in biopharmaceutical development or manufacturing, with significant focus on drug product or sterile fill-finish manufacturing.
Hands-on experience with drug product formulation or compounding, sterile filtration, filling, lyophilization, capping, crimping, stoppering, and visual inspection.
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, such as as a 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, including document control, change control, and training.
Excellent technical writing and documentation skills.
Strong problem-solving abilities and proven analytical thinking.
Effective communication and interpersonal skills, including the ability to work across departments and with client stakeholders.
Detail-oriented, with strong organizational and verbal and written communication skills.
Highly motivated self-starter with a sense of ownership and willingness to learn.
Ability to thrive in a fast-paced, growing, and dynamic work environment and form partnerships with internal and client stakeholders.
Seasoned soft skills, including high emotional intelligence; comfortable leading, delegating to, and developing team members; technology savvy.
Regular local travel to client facilities in the Research Triangle Park, NC area; periodic travel to client facilities in other regions may be required.

Nice To Haves

Master of Science, Master of Engineering, or another advanced degree.
Experience with isolator and/or RABS technology.
Experience with new facility start-up, commissioning and qualification, or technology transfer.
Experience with electronic document management platforms and electronic batch record (eBR/MES) environments.
Strong experience with MS Office products, including Outlook, Excel, PowerPoint, and Word.

Responsibilities

Serve as a Drug Product Manufacturing SME, providing technical expertise in aseptic processing, including formulation and compounding, sterile filtration, filling into drug product container closure systems such as vials, syringes, and cartridges, lyophilization, capping, crimping, stoppering, and visual inspection.
Act as functional lead for process engineers, scientists, and specialist resources by assigning and prioritizing work, providing technical direction and coaching, and ensuring deliverables meet quality, schedule, and scope expectations.
Perform technical and quality reviews of deliverables for technical accuracy, GMP regulatory compliance, GDP, and consistency with global quality standards.
Author and revise procedures and supporting documents for drug product manufacturing and related operations, including 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, such as manufacturing records, technical development reports, and global or corporate procedures, and identify improvements or remediation needs.
Partner with client functional leaders, SMEs, and Quality to gather process requirements, facilitate document reviews, adjudicate comments, and advance 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.