Process Engineer/Senior Process Engineer

Kymanox•Morrisville, NC

2d•Hybrid

About The Position

The Process Engineer / Senior Process Engineer will join Kymanox’s Technical Services team as a full-time Drug Product/Fill Finish Subject Matter Expert, 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. The role applies hands-on sterile drug product expertise to assess, author, and technically and qualitatively review site procedures, work instructions, forms, and associated training content. The position also provides day-to-day direction to document authors and training content developers and partners with client functional leaders, Quality, and Operations to deliver accurate, compliant, inspection-ready documentation. In addition to support from a direct functional manager, the role works under the guidance of a senior Kymanox project manager. The title will be commensurate with experience. The role involves supporting a large-scale site QMS implementation, including aseptic processing operations such as formulation and compounding, sterile filtration, filling, lyophilization, capping and crimping, visual inspection, and packaging. It includes document gap assessments, authoring and revising procedures, coordinating reviews and approvals through digital workflows, contributing to training materials, and supporting project governance. Documentation must align with cGMP requirements, EU GMP Annex 1, applicable ICH guidelines, 21 CFR Part 11, data integrity principles, and corporate/global quality standards. The position uses a hybrid model, with regular local travel to client facilities in the Cary, North Carolina area and approximately 3–4 days per week on-site. Responsibilities may evolve, and the company notes opportunities for advancement within the role and other organizational functions.

Requirements

Bachelor’s degree in an engineering- or science-related field, such as Chemical Engineering, Biomedical Engineering, Mechanical Engineering, Biology, Chemistry, or Biochemistry.
7–12 years of experience in the pharmaceutical, biotechnology, or combination products industry, with significant focus on drug product or sterile fill-finish manufacturing.
Hands-on experience with aseptic processing and sterile drug product manufacturing, including filling, lyophilization, visual inspection, and packaging.
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 on cross-functional projects, such as in a technical lead, functional lead, or team lead capacity.
Strong knowledge of cGMP regulations, EU GMP Annex 1, contamination control strategy, and core quality system elements, including document control, change control, deviations/CAPA, and training.
Excellent technical writing and documentation skills, including the ability to provide clear, constructive feedback to document authors.
Strong problem-solving abilities and proven analytical thinking.
Effective communication and interpersonal skills, with the ability to work across departments and with client stakeholders.
Detail-oriented, organized, and able to communicate effectively verbally and in writing.
Highly motivated self-starter with a sense of ownership and willingness to learn.
Ability to thrive in a fast-paced, growing, dynamic work environment and form partnerships with internal and client stakeholders.
Seasoned interpersonal skills, including high emotional intelligence, and comfort leading, delegating to, and developing team members.
Technology savvy.

Nice To Haves

Advanced degree, such as a Master of Science or Master of Engineering.
Experience with isolator and/or RABS technology.
Experience with new facility start-up, commissioning and qualification, or technology transfer.
Experience with electronic document management or eQMS platforms such as Veeva Vault or MasterControl, and paperless or electronic batch record (eBR/MES) environments.
Experience with MS Office products, including Outlook, Excel, PowerPoint, and Word.

Responsibilities

Serve as the Drug Product/Fill Finish subject matter expert for a large-scale site QMS implementation, providing technical expertise across aseptic processing and associated manufacturing operations.
Lead a team of document authors and training content developers 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 site QMS documents, including SOPs, work instructions, forms, and guidance documents, for technical accuracy, regulatory compliance, Good Documentation Practices, and consistency with corporate/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, environmental monitoring interfaces, visual inspection, and material flow.
Conduct gap assessments of existing global or corporate procedures against planned site operations and determine which documents can be adopted, revised, or newly created.
Partner with client functional leaders, subject matter experts, and Quality to gather process requirements, facilitate document reviews, adjudicate comments, and progress documents through digital review and approval workflows.
Review and contribute to training content, including outlines and digital training materials, for technical accuracy and alignment with 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 ALCOA+ data integrity principles for paperless operations.
Track deliverable status, identify and escalate risks, and report progress to the Kymanox project manager and client stakeholders.
Use secure artificial intelligence and other digital tools to improve authoring and review efficiency while applying technical judgment and human review to deliverables.
Mentor junior engineers and analysts and contribute to Kymanox best practices, templates, and continuous improvement of documentation workflows.