Process Engineer/Senior Process Engineer

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.

The Process Engineer / Senior Process Engineer will join our Technical Services team as a full-time Drug Product/Fill Finish Subject Matter Expert (SME), serving as a Functional Lead and Quality Reviewer on a multi-year engagement to implement a site Quality Management System (QMS) for a new, digitally enabled (paperless) cGMP manufacturing facility. In this role, you will bring hands-on sterile drug product expertise to the assessment, authoring, and technical/quality review of site procedures, work instructions, forms, and associated training content, while providing day-to-day direction to a team of document authors and training content developers. The successful candidate will partner closely with client functional leaders, Quality, and Operations to deliver accurate, compliant, and inspection-ready documentation. In addition to support from a direct, functional manager, work will also be done under the guidance of a senior Kymanox project manager. Title (Process Engineer or Senior Process Engineer) will be commensurate with experience.

Responsibilities:

• Serve as the Drug Product/Fill Finish SME for a large-scale site QMS implementation, providing technical expertise in aseptic processing, including formulation/compounding, sterile filtration, filling, lyophilization, capping/crimping, visual inspection, and packaging operations.
• Act as Functional Lead for a team of document authors and training content developers: assign and prioritize work, provide technical direction and coaching, and ensure deliverables meet quality, schedule, and scope expectations.
• Perform technical and quality review of site QMS documents (e.g., SOPs, work instructions, forms, guidance documents) for technical accuracy, regulatory compliance, Good Documentation Practices (GDP), and consistency with corporate/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, environmental monitoring interfaces, visual inspection, and material flow).
• Conduct gap assessments of existing global/corporate procedures against planned site operations to determine which documents can be adopted as-is, leveraged and revised, or newly created.
• 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.
• Review and contribute to training content (e.g., outlines, digital training materials) to ensure technical accuracy and alignment with the corresponding procedures.
• Ensure documentation complies with cGMP (21 CFR Parts 210/211), EU GMP Annex 1, applicable ICH guidelines (Q8, Q9, Q10), 21 CFR Part 11, and data integrity (ALCOA+) principles for paperless operations.
• Support project governance by tracking deliverable status, identifying and escalating risks, and reporting progress to the Kymanox project manager and client stakeholders.
• Leverage secure Artificial Intelligence (AI) and other digital tools to improve authoring and review efficiency, while applying sound technical judgment and human review to all deliverables.
• Mentor junior engineers and analysts and contribute to Kymanox best practices, templates, and continuous improvement of documentation workflows.

Educational Background:

Experience:

• 7–12 years of experience in the pharmaceutical, biotechnology, or combination products industry, with a significant focus on drug product/sterile fill finish manufacturing.
• Hands-on experience with aseptic processing and sterile drug product manufacturing (e.g., vials, prefilled syringes, cartridges), including filling, lyophilization, visual inspection, and packaging. Experience with isolator and/or RABS technology preferred.
• Demonstrated experience authoring and reviewing GMP documentation such as SOPs, work instructions, batch records, and forms, 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 cGMP regulations, EU GMP Annex 1, contamination control strategy, and core quality system elements (document control, change control, deviations/CAPA, and training).
• Experience with new facility start-up, commissioning and qualification, or technology transfer strongly preferred.
• Experience with electronic document management/eQMS platforms (e.g., Veeva Vault, MasterControl) and paperless or electronic batch record (eBR/MES) environments preferred.
• Excellent technical writing and documentation skills, with the ability to provide clear, constructive feedback to document authors.
• Strong problem-solving abilities with proven analytical thinking.
• Effective communication and interpersonal skills with ability to work across departments and with client stakeholders.
• Experience with MS Office products (Outlook, Excel, PowerPoint, Word) strongly preferred.

Desired Aptitude and Skill Set:

• 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 Cary, NC area is required (hybrid model of approximately 3–4 days per week on-site).

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.