Jobs in the United States

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Added 2 mins ago
🌍 Manufacturing & Industrial Engineering Expert, Remote- Contract
Xperteez Technology
Remote, United States
Role Title: Manufacturing & Industrial Engineering Expert
Added 48 mins ago
Production Planner
SkyWater Search
Elk River, MN
Background in engineer-to-order (ETO), make-to-order (MTO) or project-based manufacturing.
Added 1 hour ago
SSL Production Lab Engineer, Space Simulation Lab
Amazon Kuiper Manufacturing Enterprises LLC
Redmond, WA
We are seeking a Lab Engineer to run day-to-day lab operations and support production and hardware testing. You'll build and maintain test fixtures, manage lab resources and equipment, and…
Added 1 hour ago
SSL Lab Engineer 2nd shift, Space Simulation Lab
Amazon Kuiper Manufacturing Enterprises LLC
Redmond, WA
We are seeking a Lab Engineer to run day-to-day lab operations and support production and hardware testing. You'll build and maintain test fixtures, manage lab resources and equipment, and…
Added 1 hour ago
Systems Integrations Engineer (Mid-level or Senior)
The Boeing Company
North Charleston, SC
The Systems Integration Engineer will work with a dynamic and diverse Systems Integration team that supports the design, configuration, production, certification, and delivery of 787s. The…
Added 1 hour ago
Warehouse CFE & Shipping Manager
Module X Solutions
Shreveport, LA
MODULE X SOLUTIONS is a rapidly growing modular manufacturing business that serves marquee corporate and government customers in renewable energy, network infrastructure, battery storage,…
Added 1 hour ago
VI
RF Payload Systems Engineer
Viasat, Inc.
Tempe, AZ
- $176,000 to $264,000 USD / year
8+ years' experience as an RF/Systems Engineer, including hands-on design, troubleshooting, integration, and test of RF hardware at the PWA, module, unit, and system level
Added 2 hours ago
Space Avionics Test Engineer II
Varda Space Industries
El Segundo, CA
As a Space Avionics Test Engineer II, you'll play a key role in the design and operation of critical systems that simulate and stress-test flight hardware to prove it is ready for its trip…
Added 2 hours ago
Senior Space Systems Engineer, Avionics
Varda Space Industries
El Segundo, CA
The Senior Space Systems Engineer, Avionics oversees the design, integration, and testing of avionics systems for our Winnebago Spaceship. They ensure that all systems are ready for both…
Added 2 hours ago
Senior Space Avionics Test Engineer
Varda Space Industries
El Segundo, CA
As a Senior Space Avionics Test Engineer, you'll play a key role in the design and operation of critical systems that simulate and stress-test flight hardware to prove it is ready for its…
Added 2 hours ago
Senior Space Avionics Hardware Development Engineer
Varda Space Industries
El Segundo, CA
As a Senior Space Avionics Hardware Development Engineer at Varda, you will design and deliver flight-critical electrical hardware for our satellite bus, reentry vehicle, and customer…
Added 2 hours ago
Principal Space Avionics Hardware Development Engineer
Varda Space Industries
El Segundo, CA
As a Principal Space Avionics Hardware Engineer at Varda, you will be the architect and designer of flight critical electrical hardware for our satellite bus, reentry vehicle, and customer…
Added 2 hours ago
Process Engineer II
BAE Systems
Nashua, NH
BAE Systems is looking for a Process Engineer on the Advanced Compact EW Solutions (ACES) operations Tech Ops team. This position will support multiple factories in Nashua, NH including the…
Added 2 hours ago
Principal Mechanical Engineer
Actalent
Nashua, NH
We are seeking a highly motivated Principal Mechanical Engineer to provide technical leadership in the design, development, analysis, and integration of advanced electronic warfare,…
Added 2 hours ago
Quality Engineer II
BAE Systems
Nashua, NH
BAE Systems Precision Strike (PS) business area is seeking an early career Quality Engineer to support the Terminal High Altitude Area Defense (THAAD) program. In this role, you will be…
Added 2 hours ago
Manufacturing Engineer
The Timken Company
Keene, NH
Provide the engineering background and experience necessary to support all manufacturing processes, inspections, maintenance activities, and other continuous improvement projects within the…
Added 2 hours ago
Senior Data Architect
Jobgether
Remote, United States
Added 2 hours ago
Sr. Electrical Project Engineer
Kohler Co.
KOHLER, WI
…industry to build future competitive advantage for Kohler’s manufacturing processes. The individual will partner with the plant’s engineering manager and teams along with close…
Added 3 hours ago
IC
Semiconductor Device Modeling Engineer
Intel Corporation
OR
- $173,660 to $330,340 USD / year
…pillar in enabling Intel to deliver design, development and manufacturing services that allow Intel Foundry customers to deliver winning products to the marketplace. Your work will directly…
Added 3 hours ago
IC
Thin Films Module Development Engineer
Intel Corporation
OR
- $155,520 to $255,200 USD / year
Experience in semiconductor manufacturing or process development includes one or more of the following:
Added 3 hours ago
Manufacturing Engineer
West Pharmaceutical Services
Kearney, NE
In this fully on-site role the Manufacturing Engineer is a Subject Matter Expert responsible for leading and/or supporting technical engineering projects. Projects will be executed in…
Added 3 hours ago
Electronics Engineer
US Army Civilian Human Resources Agency
Fort Huachuca, AZ
…transcripts is in this document. Basic Requirement for Electronics Engineer: A. Degree: Bachelor's degree (or higher degree) in engineering. To be acceptable, the program must: (1) lead to…
Added 3 hours ago
Plant Environmental Control Engineer
Ford Motor Company
Wittmann, AZ
We are looking for an experienced plant environmental engineer to provide technical and regulatory environmental support to the non-manufacturing team at the Arizona Proving Grounds (APG).…
Added 3 hours ago
M
Construction Manager - Engineer
ManpowerGroup
Casa Grande, AZ
- $35 to $40 USD / hour
Minimum 5+ years of construction management experience in industrial, manufacturing, food, pharmaceutical, or related facilities.
Added 3 hours ago
Sr. Quality Assurance Engineer
Ralliant
Chandler, AZ
…strengthen quality performance in our aerospace and defense manufacturing operations. Each engineer will take independent ownership of manufacturing quality in assigned areas while serving…

Kymanox

Process Engineer/Senior Process Engineer

Morrisville, NC, United States

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Job details

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.
Posting language: English
Posted: Oct 30, 2026

Original job description

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:

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:

7–12 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.

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More about this job

Skills

Quality assurance procedures
Inspection
Documentation
Packaging functions
Coaching
Regulatory compliance
Cleaning
Good manufacturing practices
Reporting
Artificial intelligence
Process improvement
Chemical engineering
Biomedical engineering
Mechanical engineering
Biotechnology
Packaging
Document management
MasterControl
MES
Technical writing
Problem solving
Analytical skills
Communication skills
Interpersonal skills
Microsoft Office
Microsoft Outlook
Microsoft Excel
Microsoft PowerPoint
Microsoft Word
Organizational skills
Hybrid model

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