About the role
Job Description:
Is Kymanox the right fit for you?
You want to make a difference and have an impact…
You enjoy having an influence in your day-to-day work…
You are motivated by working alongside a team filled with
subject matter experts who will help you learn and grow…
You wake up every day and do what you do
… because patients deserve better.
If this sounds like you, you’ve come to the right place.
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. This role may involve assessment, authoring, and technical/quality review of manufacturing procedures, plans, protocols, work instructions, forms, and associated training content. This role 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 closely with client functional leaders and executive stakeholders, as well as Kymanox functional leads, to deliver technically accurate and compliant solutions for their area of expertise. Title/level will be commensurate with skill set and experience.
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.
Career Development:
The position will evolve over time and more responsibilities may be added. Since Kymanox is a growing company, there are opportunities for advancement both within the currently defined role and in other functions within the organization.
Compensation:
Base salary is commensurate with experience, qualifications, and other intangibles evident during the interview process – as well as market conditions. Eligible for incentive program after 6 months of outstanding work.
Benefits:
Medical healthcare including dental and vision, short- and long-term disability, life insurance, matching 401(k) retirement plan, continuing education assistance, and other benefits.
About Kymanox:
Join Kymanox – a life sciences professional services company dedicated to life sciences who has successfully delivered over 4000 projects across 20+ countries. Become a member of a dynamic, fulfilling team that helps a broad range of life science products get to market more quickly, more affordably, and with the highest quality and safety standards possible in today’s biotechnology, pharmaceutical, medical device, and combination product industries. With a reputation of providing unparalleled professional services and our highly collaborative team of engineering, compliance, and project management experts, Kymanox provides an outstanding opportunity for learning and career advancement. Kymanox encourages team members, especially new graduates, and young professionals, to work on a variety of projects to gain increased learnings in Kymanox’s service offerings and the life science industry as a whole.
Kymanox is looking for motivated individuals who want to solve problems in the life science industries while doing the work they love and helping get modern medicines that enhance and save patient lives to market. Kymanox provides professional services related to engineering, compliance, and project management. We service clients ranging from Fortune 100 companies to virtual start-up companies. The company was founded in 2004 and has been growing steadily since its inception. Our corporate HQ is based in Research Triangle Park, NC.
To learn more about our company, please visit our website: Life Science Solutions | Kymanox
Kymanox is an equal-opportunity employer and works diligently to protect the rights of job seekers by following all local, state, and federal laws as well as best Human Resource (HR) practices in the Life Science industry.
Text as published by Kymanox. We don't edit postings; apply and ask questions on the employer's site.