Jobs in the United States

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Added 7 mins ago
GE
Gusmer Enterprises
Gusmer Enterprises
Waupaca, WI
- $75,000 to $85,000 USD / year
Experience within a ISO9001 certified company or other highly regulated environments, with some involvement in QMS, is preferred.
Added 4 hours ago
Engineer – Internal Logistics Innovation & Projects
TKY Toyota Motor Mfg Kentucky, Inc Company
Georgetown, KY
Reporting to the Manager, the person in this role will support the Production Control Department’s objective of ensuring safe, stable, efficient, and highly productive conveyance processes.
Added 4 hours ago
Quality Assurance-Multiple Locations
PPG Industries, Inc.
United States
As a Quality Assurance Manager, we are looking for Quality Assurance champions to lead a culture of quality excellence at PPG manufacturing facilities. In this leadership role, you will be…
Added 7 hours ago
Quality Manager - Portland, TN
North American Stamping Group
Portland, TN
North American Stamping Group is expanding and looking to hire. We are looking for an experienced Quality Manager to join our team at our Portland, TN Plant 2 facility! As a key Leader of…
Added 8 hours ago
SC
QA Specialist I
Sofie Co.
Totowa, NJ (NJ3), NJ
- $33 to $36 USD / hour
Reports To | Regional Manager, Quality Assurance (or equivalent QA Manager)
Added 10 hours ago
EC
Training Supervisor
Eaton Corporation
Omaha, NE
- $86,000 to $126,000 USD / year
Reporting to the HR Manager, the Training Supervisor is responsible for owning and improving the training system for hourly manufacturing employees. The primary focus of this role is…
Added 11 hours ago
Quality Control Manager
Rittal North America LLC
Urbana, OH
The Quality Control Manager leads all inspection, verification, and product conformance activities within an ISO 9001-certified manufacturing environment. This role oversees daily quality…
Added 11 hours ago
QMS & Quality Data Technician - K9 & Kin
Kalmbach Feeds Inc
Carey, OH
As K9 & Kin continues to grow, we are seeking a highly organized and detail-oriented QMS & Quality Data Technician to support the Quality Assurance and Food Safety teams at our…
Added 14 hours ago
MA
Senior Manager, Cord Blood Bank Quality
MD Anderson Cancer Center
Houston, TX
- $135,975 to $204,000 USD / year
The Sr. Manager, Cord Blood Bank Quality provides strategic and operational leadership for the Quality Management System of a public cord blood bank licensed by the U.S. Food and Drug…
Added 20 hours ago
Lab Supervisor | 3rd Shift | Rancho Dominiguez
Techmer PM
Compton, CA
…maintaining compliance with the Quality Management System (QMS), ISO 9001. The ideal candidate is a strong leader who excels in quality management, employee development,…
Added 1 day ago
Change Control Specialist III
Graphic Controls Acquisition Corp
BUFFALO, NY
…position facilitates the Engineering Change Order (ECO) and QMS Change Order (CO) processes owned by the Quality Department. Ensures that all necessary requirements are completed/reviewed…
Added 1 day ago
Production Supervisor
Multi-Color Corporation
Tyrone, PA
Works with Production Manager to implement and align departmental initiatives with plant operational goals; supports and drives reinforcement activities.
Added 1 day ago
Quality and Continuous Improvement Manager
Image Associates Inc.
Davenport, IA
This is a Quality and Continuous Improvement Manager position with a company that manufactures metal parts and assemblies. People with appropriate experience who come from similar…
Added 1 day ago
Sr Quality Manager, QMS
BD (Becton, Dickinson and Company)
El Paso, TX
Work directly with the Pharma COE QMS Director to align site NCI, CAPA, and Change Control processes with COE and enterprise QMS standards; escalate systemic issues; implement COE-led…
Added 1 day ago
Senior Quality Manager
Ducommun
Huntsville, AR
The Senior Quality Manager provides strategic leadership and direction for the organization's Quality Management System (QMS), ensuring compliance with customer, regulatory, and industry…
Added 1 day ago
Quality Manager
US0767 Prysmian Cables and Systems Usa LLC
Sedalia, MO
Accountable to the North American I&C Regional Quality Manager, the Sedalia Quality Manager is responsible for Prysmian's aluminum building wire operations within North America. The…
Added 1 day ago
Manager, Post Market Surveillance
Inspire Medical Systems, Inc.
Minneapolis, MN
Perform, support, mentor, and coach team on medical device QMS requirements and best practices for achieving "best in class" performance and process throughput.
Added 1 day ago
Mechanical Thermal Analysis Engineer II-IV
Kratos Defense & Security Solutions, Inc.
Roseville, CA
Acts as the Lead Thermal Engineer for very complex projects as assigned by Manager that affect multiple systems, involve several suppliers/teaming partners, and require frequent customer…
Added 1 day ago
Mechanical Thermal Analysis Engineer II - IV (Active Clearance Required)
Kratos Defense & Security Solutions, Inc.
Sacramento, CA
Acts as the Lead Thermal Engineer for very complex projects as assigned by Manager that affect multiple systems, involve several suppliers/teaming partners, and require frequent customer…
Added 2 days ago
Quality Manager (Olathe, Kansas (KS), US, 66061)
SPX
Olathe, KS
The Senior Quality Manager is responsible for implementing the quality strategy, systems, and performance initiatives across the Cooling business. This role ensures products and processes…
Added 2 days ago
Quality Control Manager
Audiosears Corporation
STAMFORD, NY
…associated with the operation.SUMMARY: The Quality Control Manager sets the overall strategic direction for achieving world class quality levels as measured by our customers. Achieves and…
Added 2 days ago
AD
Quality Assurance Specialist - Manufacturing (Longmont, CO)
Antech Diagnostics
Longmont, CO
- $60,000 to $76,000 USD / year
…facilities. Working under general supervision from the Quality Manager, this position ensures that products, processes, raw materials, and finished goods consistently conform to corporate…
Added 2 days ago
Quality Assurance Engineer
Fujifilm
Mesa, AZ
The Quality Assurance Engineer is responsible for executing and improving key QMS processes to drive improvements in FEUS processes and product quality, at a pace consistent with the needs…
Added 2 days ago
Senior Master Data Manager
IREN
San Francisco, CA
The Senior Master Data Manager owns the strategy, structure, and governance of master data across IREN's AI infrastructure and data center supply chain, and ensures that finance,…
Added 2 days ago
Quality Assurance Specialist
Leonardo Helicopters US Corporation
United States
Perform system, process, and product audits of the QMS. Provide oversight and assistance to the Organization with the main focus on Production, Customer Support and Training (including…

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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