Jobs in the United States

25+ jobs

Save this search

Added 7 mins ago
Supplier Quality Engineer II
Medtronic
Boulder, CO
…growth and cross-functional collaboration as we work together to engineer the…
Added 7 mins ago
PT
Electrical Controls Engineer
PDS Tech Commercial
Arvada, CO
- $150 USD / hour
PDS Tech Commercial is seeking an experienced Electrical Controls Engineer to design, program, test, and commission advanced industrial control systems used in large-scale manufacturing and…
Added 7 mins ago
Supervisory Civil Engineer
Bureau of Reclamation
Grand Junction, CO
Summary You will serve as a Supervisory Civil Engineer in the Upper Colorado Basin; Western Colorado Area Office in Grand Junction, Colorado. First time hires to the Federal government…
Added 7 mins ago
K
Mid-Level Civil Engineer - Kiewit Power Engineering
Kiewit
Lone Tree, CO
- $95,000 to $100,000 USD / year
…mid-level Civil Engineers to join their engineering team. The Civil Engineer will support projects in site development for a wide variety of industries. The successful candidate will bring…
Added 7 mins ago
K
Senior Civil Engineer - Kiewit Power Engineering
Kiewit
Lone Tree, CO
- $138,000 to $145,000 USD / year
Lead site civil design tasks and teams, acting as responsible engineer in charge as needed.
Added 7 mins ago
Civil - Senior Engineering Technician - BESS Job Details | Black & Veatch Family of Companies
Black & Veatch
Greenwood Village, CO
…for these complex infrastructure projects. Functioning in a lead technician capacity, this position performs technical tasks requiring advanced knowledge of civil engineering principles and…
Added 7 mins ago
Electrical Engineer - Power System Studies (Distribution) Job Details | Black & Veatch Family of Companies
Black & Veatch
Greenwood Village, CO
Electrical Engineer - Power System Studies (Distribution)
Added 7 mins ago
CIVIL ENGINEER (CONSTRUCTION MANAGEMENT)
Bureau of Reclamation
Lakewood, CO
Summary You will serve as a CIVIL ENGINEER (CONSTRUCTION MANAGEMENT) This position is located within the Department of the Interior, Bureau of Reclamation, Denver, Construction Manamgement…
Added 7 mins ago
RS
Sr. Quality Assurance Engineer (QA Engineer, Senior)
Redwire Space, Inc.
Littleton, CO
- $100,000 to $130,000 USD / year
Added 8 mins ago
Bridge Engineer - Kiewit Infrastructure Engineers
Kiewit
Lone Tree, CO · Denver, CO
…rapidly mobilize the necessary resources for any Design/Build project. Clients are turning to us for Design/Build and other alternative project delivery methods due to our successful track…
Added 8 mins ago
Principal Software Engineer
Highmark Health
Denver, CO
We are seeking a visionary Principal Software Engineer responsible for building scalable public-facing software applications across Digital Member Experience channels. As a key player…
Added 8 mins ago
Senior Data Scientist Engineer - SFL Scientific
Deloitte
Denver, CO
Lead client initiatives to deliver AI/ML solutions, including providing thought leadership, long-term maintenance, and AI strategy objectives
Added 8 mins ago
O
Lead Principal Software Development Engineer
Oracle
Denver, CO
- $135,200 to $306,400 USD / year
As a Sr. Principal Software Development Engineer in the Oracle Cloud Infrastructure (OCI) Core Platform division, you will play a critical leadership role in the architecture, evolution,…
Added 8 mins ago
IC
Mechanical Project Engineer - Commercial Interiors | Denver, CO
IMEG Consultants Cor
Denver, CO
- $98,000 to $131,000 USD / year
Mechanical Project Engineer - Commercial Interiors | Greenwood Village, CO 100% Employee-Owned | Big-firm resources, local-team relationships, ONE IMEG culture IMEG is hiring a Mechanical…
Added 8 mins ago
Telecom Engineer IV
Ryder System
Denver, CO
The Telecom Engineer IV will provide Tier 3 and 4 support, engineering / design, testing and deployment in all areas of responsibility of the Enterprise Voice Team; Voice Facilities, UCaaS…
Added 8 mins ago
Big Data Systems Engineer
Trinzic
Denver, CO
The Big Data Systems Engineer will work on the deployment and integration of a highly visible data analytic project called Cloud Hybrid Edge-to-Enterprise Evaluation Test & Analysis Suite…
Added 8 mins ago
EG
Knowledge Graph Architect
Eliassen Group
Denver, CO
- $100 to $120 USD / hour
Our client is seeking a Knowledge Graph Architect to lead the architecture and technical strategy for a construction-focused ontology, knowledge graph, and AI knowledge platform. You will…
Added 19 mins ago
W
Quality Engineer - Supply Chain
Walmart
MIDWAY, TN
- $80,000 to $120,000 USD / year
…optimized performance across our facility. In this role, you’ll lead data‑driven improvements, strengthen process consistency, and partner closely with area leaders to reduce loss and…
Added 21 mins ago
W
Software Engineer III
Walmart
BENTONVILLE, AR
- $90,000 to $180,000 USD / year
As a Software Engineer III, you will lead the design and development of scalable software solutions by collaborating with cross-functional teams including product management and user…
Added 23 mins ago
EG
Knowledge Graph Architect
Eliassen Group
Charleston, WV
- $100 to $120 USD / hour
Our client is seeking a Knowledge Graph Architect to lead the architecture and technical strategy for a construction-focused ontology, knowledge graph, and AI knowledge platform. You will…
Added 29 mins ago
Lead Electrical Engineer
Cleveland-Cliffs Inc.
East Chicago, IN
Cleveland-Cliffs Steel is seeking a Lead Electrical Engineer to support our manufacturing operations at our Indiana Harbor facility. This key leadership role will drive electrical…
Added 29 mins ago
Project Manager II - Transmission Focus
Duke Energy
Plainfield, IN
Create, Staff, and Lead the Project Team (25%)
Added 30 mins ago
Scientist/Engineer, Mixed Modality Technical Operations - Lilly Medicine Foundry
Lilly
Lebanon, IN · Indianapolis, IN
The Scientist/Engineer – Technical Operations becomes an expert in their assigned area, Small Molecule, Hybrid, or Biologics, and serves as a key integrator with Process Engineering,…
Added 30 mins ago
Marion Manufacturing Engineer
US0767 Prysmian Cables and Systems Usa LLC
Marion, IN
Lead manufacturing readiness activities for new product launches, including process development, validation, and documentation.
Added 30 mins ago
SC
Lead Manufacturing Engineer - (Machining)
SMC Corporation of America
Noblesville, IN
- $74,666 to $109,333 USD / year
The purpose of a Lead Manufacturing Engineer is to design, implement, optimize, and troubleshoot manufacturing processes within the organization. This position plays a crucial role in…

Kymanox

Process Engineer/Senior Process Engineer

Morrisville, NC, United States

Apply About employer

Applications open in a new tab.

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.

Apply About employer

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

Report this job