Jobs in the United States

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Added 1 min ago
SU
Service Innovation & Development Intern
Sungrow USA Corporation
Houston, TX
- $25 to $30 USD / hour
…AI Agent product owner within the Strategic Expert team, the developer takes well-scoped features, bug fixes and data tasks from the backlog and covers the routine maintenance the service…
Added 1 min ago
Forward Deployed Engineer, AI Transformation -Senior Vice President
Citi
IRVING, TX · Irving, TX · Irving
Domain Expertise: Knowledge of a specific business domain such as payments, finance and operations in financial services firms.
Added 2 mins ago
Product Manager, Higher Education Discipline Product- Computing
Cengage Learning Inc.
OH
…product-adjacent roles such as product management, product operations, UX, analytics, content strategy, engineering, or business…
Added 2 mins ago
Software Product Management Pre Sales Senior Manager - Consumer Goods & Services
Accenture LLP Company
NY
Added 2 mins ago
AF
Scrum Master - 6519351
Accenture Flex LLC Company
Morristown, NJ
- $44 to $54 USD / hour
Advanced proficiency in Scrum Methodology and Jira Operations
Added 4 mins ago
BI
Vice President Software
Biolinq Incorporated
San Diego, CA
- $225,000 to $300,000 USD / year
…Product, Design, Systems, Quality, Regulatory, Clinical, and Operations, and ensures that software is a strategic differentiator as Biolinq scales commercially and expands its continuous…
Added 4 mins ago
Mission Engineer II - Grand Rapids
Axon
Remote, United States
Connect the right resources across Product, Engineering, Support, Deployment, Training, Mission Operations, Mission Success, and Sales.
Added 4 mins ago
HG
H&M Sales Advisor (Seasonal) - Quail Springs Mall
H&M Group
Oklahoma City, OK
- $13.5 USD / hour
Retain and share your service, fashion and store operations knowledge and skills with colleagues
Added 4 mins ago
CC
Order Management and Fulfillment Coordinator
Carrier Corporation
Charlotte, NC
- $79,000 to $158,000 USD / year
Lead site order management by aligning SIOP, Sales, and factory operations to deliver customer commitments. Drive cross-functional collaboration, resolve delivery exceptions, and maintain…
Added 7 mins ago
Director, DevCon Platform Engineering
Marriott
Remote, United States
The Director, DevCon Platform Engineering leads the Internal Developer Platform (IDP) team and drives product strategy, execution, and adoption. The DevCon product serves as the…
Added 7 mins ago
Senior Recruiter
Rhombus
Sacramento, CA
…sensors, and AI analytics to help organizations improve safety and operations at scale. We have a solid product-market fit, customers love us, and our solution makes a profound impact and…
Added 9 mins ago
Workplace Operations Coordinator
Checkr
Nashville, TN
Our Workplace Operations and Talent Coordinator, reporting into Workplace, will be essential to the Workplace team's function and will hugely impact our company culture and workplace…
Added 10 mins ago
Learning Experience and Readiness Specialist
Curriculum Associates, LLC
Remote, United States
…presentations, logistics with the Learning and Development Operations team, and post-event…
Added 11 mins ago
TJ
Manager of HR Operations
The Joint Chiropractic
Scottsdale, AZ
- $190,000 to $215,000 USD / year
We’re looking for a Manager of HR Operations to be a hands-on HR generalist for our corporate team. You’ll keep our policies current and compliant, run the programs that drive performance…
Added 12 mins ago
Staff+ Software Engineer, Backend
Anthropic
San Francisco, CA · New York City, NY
…API - the systems that deliver Claude's intelligence to every developer, from startups to enterprise. You'll own the performance, reliability, and efficiency of our core serving path,…
Added 13 mins ago
Assistant Director for Pre-College Programs - Division of Student Affairs
Carnegie Mellon University
Pittsburgh, PA
…will contribute to the program by coordinating logistics and operations related to the program’s many meta-curricular activities and developing a robust outside-of-the-classroom experience…
Added 14 mins ago
Sr Director, Product Management - Supply Chain
Five Below Inc
Philadelphia, PA
…warehouse, global trade, fulfillment, and supply chain analytics…
Added 14 mins ago
Director of Billing and Collections
ServiceTitan, Inc.
Remote, United States
…lead and optimize our global end-to-end Order-to-Cash (O2C) operations. In this high-impact leadership position, you will oversee customer invoicing, collections, and accounts receivable,…
Added 14 mins ago
Senior Analyst, Marketing Strategy & Operations
ServiceTitan, Inc.
Glendale, CA
The Senior Analyst, Marketing Strategy & Operations is an analytical and operational partner to the Marketing team, helping Marketing make smarter decisions about strategy, operations, and…
Added 15 mins ago
Diversity Liaison- Oregon State Hospital (OPA3 SR 30)
Oregon Health Authority
United States
Opportunity Awaits, Apply Today! – Diversity Liaison-Oregon State Hospital (OSH) (Operations & Policy Analyst 3)
Added 17 mins ago
I
Supply Chain Contracts Manager
IREN
San Francisco, CA
- $190,000 to $240,000 USD / year
Added 18 mins ago
Site Reliability Engineer 2 - Production Engineering
Anduril Industries
Seattle, WA
…closely with platform engineers, product developers, and field operations to proactively identify reliability risks, respond to incidents, and help owning teams improve the operational…
Added 18 mins ago
Site Reliability Engineer 2 - Production Engineering
Anduril Industries
Costa Mesa, CA · Seattle, WA
…closely with platform engineers, product developers, and field operations to proactively identify reliability risks, respond to incidents, and help owning teams improve the operational…
Added 23 mins ago
Product Owner, Workforce Management (Verint)
American Express
Sunrise, FL · Phoenix, AZ
The Product Owner will serve as a key connection point across Workforce Management, Operations, Technology, Analytics, Digital Product, and Verint, combining strong knowledge of workforce…
Added 24 mins ago
V
Global Director, Demand Generation
VONTIER
United States
- $150,000 to $200,000 USD / year
Define and maintain funnel stages, lead and account scoring, routing and SLAs with Sales Operations in Salesforce and the marketing automation platform.

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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