Jobs in the United States

25+ jobs

Save this search

Added 6 mins ago
O
Lead Principal Software Development Engineer
Oracle
Olympia, WA
- $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 6 mins ago
Staff ML Systems Engineer
General Motors
Olympia, WA
This role is ideal for an engineer looking for end-to-end ownership of meaningful pieces of the platform, growth in technical and strategic leadership, and direct impact across teams and…
Added 6 mins ago
Senior Staff Software Engineer, Institutional Exchange
Coinbase
Olympia, WA
…markets with speed, depth, and trust. As a Senior Staff Software Engineer on the Exchange team, you'll set the architectural direction for the matching engine, order management, market…
Added 6 mins ago
Director, AI Engineer (Remote Eligible)
Capital One
Olympia, WA
…mentoring and coaching. You are hands-on when necessary and lead by…
Added 6 mins ago
Principal Software Engineer
Highmark Health
Olympia, WA
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 6 mins ago
Senior Staff Full-stack Engineer - Global Payment Network (Remote - Eligible)
Capital One
Olympia, WA
As a Senior Staff Engineer at Capital One, you will be part of a community of technical experts working to define the future of banking in the cloud. You will work alongside our talented…
Added 7 mins ago
AT
Principal Software Engineer - (Reston or Cambridge)
Akamai Technologies, Inc.
Olympia, WA
- $169,300 to $304,700 USD / year
As a Principal Software Engineer Lead, you will be responsible for:
Added 7 mins ago
Senior Data Scientist Engineer - SFL Scientific
Deloitte
Seattle, WA
Lead client initiatives to deliver AI/ML solutions, including providing thought leadership, long-term maintenance, and AI strategy objectives
Added 7 mins ago
Google Infrastructure and Security Lead Architect
Deloitte
Seattle, WA
As a Google Cloud (GCP) Infrastructure & Security Lead Architect, you will serve as a strategic technical leader and trusted advisor for our enterprise clients, guiding them through complex…
Added 7 mins ago
Google AI Architect
Deloitte
Seattle, WA
Lead cloud-native development on GKE, Cloud Run, Pub/Sub, BigQuery, Cloud SQL/Spanner, Memorystore, and Terraform; enforce application and agentic design patterns.
Added 7 mins ago
HPC AI Solution Architect (S2S)
Deloitte
Seattle, WA
As a Lead Cloud Integrated Infra Engineer on the Silicon2Service team in Deloitte's AI & Engineering practice, you will design and drive deployment of fully integrated architectures for…
Added 7 mins ago
ConvergeHEALTH Life Sciences - Product Forward Deployed Engineer - Products & Platforms
Deloitte
Seattle, WA
As a Product Forward Deployed Engineer (pFDE), this role is the technical engine of the FastForward pre-sales cycle. Working across Product Management, Engineering, Account, and Pursuit…
Added 7 mins ago
ConvergeHEALTH Life Sciences - Product Forward Deployed Engineer - Products & Platforms
Deloitte
Seattle, WA
As a Product Forward Deployed Engineer (pFDE), this role is the technical engine of the FastForward pre-sales cycle. Working across Product Management, Engineering, Account, and Pursuit…
Added 7 mins ago
Software Development Manager, Featured Merchant Algorithm
Amazon
Seattle, WA
Lead a high performing team of 10 engineers, transforming the most visible and high impact tier-1 service with AI native development
Added 7 mins ago
Lead Product Software Engineer (DevOps/Web Dev)
Disney Entertainment
Seattle, WA
Modernization and Migration : Lead migrations of legacy stacks onto current platforms, scoping the work, sequencing it against live traffic, and carrying it to completion without…
Added 7 mins ago
Sr. Software Development Engineer, Trainium Systems
Amazon
Seattle, WA
A deeply technical engineer who stays close to both the customer and the system design. You dive deep to understand how the hardware and the software actually behave, you decide when a…
Added 7 mins ago
Cyber Operate Manager - Identity Security Architect & Product Engineering
Deloitte
Bellevue, WA · Seattle, WA
Join Deloitte as a Lead Managed Services Engineer II and help design, engineer, and deploy identity security capabilities across enterprise environments. You will advance attack path…
Added 7 mins ago
Confluent - Staff Software Engineer
IBM
Bellevue, WA · Seattle, WA
As a Senior Software Engineer on Kora Compute, you will design, build, and operate distributed systems that power Kafka workloads at cloud scale. You may work on broker reliability and…
Added 7 mins ago
Cyber Operate Manager - GCP Cloud DevOps Engineer
Deloitte
Seattle, WA · Bellevue, WA
Deloitte is seeking a Lead Managed Services Engineer II to design, automate, and operate enterprise-scale cloud capabilities that support clients' critical cyber assets. In this role, you…
Added 7 mins ago
EG
Dev Lead
Eliassen Group
Olympia, WA
- $110 to $120 USD / hour
Our client seeks a Dev Lead to own architecture, code quality, and delivery for an Agile squad building AI solutions that enable knowledge discovery and reuse. The role balances hands-on…
Added 7 mins ago
EG
Knowledge Graph Architect
Eliassen Group
Olympia, WA
- $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 20 mins ago
Integration Engineer 5 - Payment Network Partner Experience
Capital One
Riverwoods, IL
As an Integration Engineer in the Global Payment Network (GPN), you will leverage your technical acumen, domain knowledge, and strategic architecture vision to shape how our clients…
Added 20 mins ago
Senior Engineer – Identity & Access Management (Remote)
United Airlines
Chicago, IL
…Join our Cybersecurity and Digital Risk (CDR) team to help lead the industry in cyber safety, security and resilience. United's CDR team plays a critical role in protecting our operations…
Added 20 mins ago
Full-Stack Engineer 4 (SQL Server DBA)
Capital One
Riverwoods, IL · Chicago, IL
Lead end-to-end planning and execution for large-scale database patching, version upgrades, backups, restores, and decommissioning strategies.
Added 20 mins ago
Senior Frontend Engineer (LATAM)
Lateral Group
Remote, United States
Lead and take ownership: As a senior member, you’ll drive projects from concept to completion. That means making technical decisions, outlining implementation plans, and seeing them through…

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