Jobs in the United States

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Added 1 min ago
Senior Software Engineering Manager, System Software
HP
San Francisco
Lead, grow and mentor a high-performing embedded software team in a startup environment
Added 1 min ago
Product Marketing Manager, AI Solutions – Higher Education & Research
HP
Fort Collins · Spring
…customers and meet business goals. The role plans and manages technical programs or projects, effectively steering them to meet specific roadmap and feature objectives. The role develops a…
Added 9 mins ago
Dir US Domestic Tax
IGT, a Nevada Corporation
Reno, NV
Lead, coach, and develop the domestic tax team, setting clear accountabilities and building technical depth and succession.
Added 16 mins ago
Unified Payables - Product Manager
U.S. Bank National Association
Minneapolis, MN · Atlanta, GA · Denver, CO
As the Product Manager, Unified Payables, you will be the dedicated, hands-on product owner for U.S. Bank's Unified Payables offering for middle-market clients: one bank-backed experience…
Added 20 mins ago
TO
Winter Maintenance Worker
Town of Frisco
Frisco, CO
- $21.5 USD / hour
Reports to: Grounds and Streets Manager. Streets Lead and/or Grounds Leads provide direction in daily tasks.
Added 21 mins ago
FC
Growth Marketing Manager
Fuel Cycle
Los Angeles, CA
- $85,000 to $110,000 USD / year
Fuel Cycle is hiring a hands-on Growth Marketing Manager to run our funnel end to end: the channels that bring buyers in (paid, search, website), the workflows that move them toward a…
Added 26 mins ago
Technical Account Manager - USA
Camunda
Remote, United States
- At least 3 years of experience as a Technical Account Manager or a directly comparable role in enterprise software
Added 32 mins ago
Cloud Solutions Architect
USA7 DXC Technology Services LLC
ANY CITY, FL
The Manager, Solution Architecture is responsible for the design, development, and integration of IT and IT-enabled services and solutions that address the business needs of external…
Added 33 mins ago
Unified Payables - Product Manager
U.S. Bank National Association
Minneapolis, MN
As the Product Manager, Unified Payables, you will be the dedicated, hands-on product owner for U.S. Bank's Unified Payables offering for middle-market clients: one bank-backed experience…
Added 38 mins ago
AI Product Manager
John Deere
Johnston · Moline
Digital Engagement & Commerce requires a dedicated Product Manager to build and scale AI-powered parts experiences across Shop.Deere.com, Deere.com, and Unified Parts Experience.
Added 40 mins ago
R
Engineer I
Rosendin
San Francisco, CA
- $85,200 to $111,900 USD / year
…Responsibilities. Part of the responsibility will be to provide technical engineering design, consultation, information, and assistance to internal and external customers under the direct…
Added 40 mins ago
Manager Systems Engineering - Configuration Management 3 (AHT)
DS - Advanced Weapons - Northridge
United States
Northrop Grumman Defense Systems is looking for a Manager Systems Engineering - Configuration Management 3 to lead a team of Configuration Analysts, Data Managers, Technical Writers, and…
Added 40 mins ago
Program Manager 2 - Deputy Program Manager
CORP-Corporate Office
United States
The Swordfish Portfolio is seeking a Deputy Program Manager (DPM) to drive execution across a complex, multi‑program portfolio supporting Space Force Space Systems Command (SSC) and the…
Added 41 mins ago
EPIC Certified Systems Analyst Sr (Resolute HB/PB)
Inova
United States
Facilitates Epic updates, new releases and system enhancements. Manages all phases of testing and assists Lead/Project Manager in work effort and project scoping.
Added 42 mins ago
Program Manager
PAC SEATING SYSTEMS LLC
Palm City, FL · PALM CITY, FL
Plans, directs, and coordinates activities of designated program / projects to ensure that goals or objectives of program / projects are accomplished within prescribed time frame and…
Added 44 mins ago
PP
Senior Project Manager
PIT Pitzer College
United States
- $110,000 to $120,000 USD / year
The Senior Project Manager for Data, Systems, and Integrations provides institution-wide leadership for enterprise data, systems coordination, integrations, project governance, and process…
Added 46 mins ago
Senior Capital Projects Manager
Educational Service District 112
Vancouver, WA
Under the general direction of the Associate Director of the Construction Services Group, the Senior Capital Project Manager leads the successful K-12 building projects, finishing them on…
Added 46 mins ago
Medicaid Certification PMO Project Manager
NTT DATA State Health Consulting, LLC
Springfield
…of factors, including the candidate’s relevant experience, technical skills, and other qualifications. This position is eligible for company benefits including medical, dental, and vision…
Added 46 mins ago
PMO Quality Project Manager
NTT DATA State Health Consulting, LLC
Springfield
NTT DATA seeks to hire an experienced PMO Quality Project Manager to support the Illinois Medicaid Enterprise System (IL MES) PASS Program. The role will lead Enterprise PMO quality…
Added 48 mins ago
Procurement Project Manager
Integra
Houston, TX · Akron, OH
Align procurement milestones with overall project milestones through collaborating with the Product Program Manager
Added 49 mins ago
Senior Engineering Product Manager - Strategic Partnership Initiatives
Cisco
Boulder, CO
Lead the definition and execution of strategic partnership initiatives that expand the Splunk Platform’s reach and utility across major hyperscaler and partner ecosystems. You will define…
Added 51 mins ago
Supervisory Medical Administration Specialist (Scheduling Manager)
Veterans Affairs, Veterans Health Administration
Sheridan, WY
Added 51 mins ago
EG
Product Manager
Eliassen Group
Cheyenne, WY
- $70 USD / hour
Our client seeks a Product Manager to lead product planning and execution across the lifecycle for Oracle Retail Demand Forecasting (RDF) and Oracle Retail Merchandising System (RMS). The…
Added 52 mins ago
BE
Sr Manager Technology - API Platform
Boeing Employees' Credit Union
Remote, United States
- $135,100 to $250,600 USD / year
The Sr. Manager, Technology – API Platform is responsible for leading the execution of BECU’s API strategy by delivering enterprise APIs and platform capabilities that securely expose…
Added 53 mins ago
Senior OSP Controls Project Manager
Zayo
Providence, RI
The Senior Project Manager, Long Haul Controls leads the controls framework supporting Long Haul OSP projects from initial handoff into Construction through closeout. The role ensures…

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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