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Added 9 mins ago
Senior Product Owner / Product Manager
Jobgether
Remote, United States
As a Senior Product Owner / Product Manager, you will lead the development of a new software application for a U.S. public-sector client, taking it from early concept through launch.…
Added 9 mins ago
J
Customer Success Manager
Jobgether
Remote, United States
- $80,000 to $110,000 USD / year
As a Customer Success Manager, you will help organizations maximize the value of advanced cybersecurity solutions throughout their customer journey. You will build trusted relationships,…
Added 12 mins ago
GSOC Manager - Protective Operations
Crisis24
West Palm Beach, FL
The GSOC Manager is responsible for the leadership, performance, and continuous improvement of Global Security Operations Center activities supporting high-profile clients, properties, and…
Added 19 mins ago
Senior Account Executive, Public Affairs, Healthcare (VOX Global)
VOXUS VOX Global, LLC
Washington, DC
Experience executing campaigns to enhance client reputations and shape public narratives.
Added 23 mins ago
AC
Demand Planning Manager
Aston Carter
Sacramento, CA
- $45 to $55 USD / hour
Aston Carter provides world-class corporate talent solutions to thousands of clients across the globe. Specialized in accounting, finance, human resources, talent acquisition, procurement,…
Added 35 mins ago
Premier Banker- Plaistow
TD Bank
Plaistow, NH
…products, offerings, and processes to fluently explain banking solutions to a client and to act as an experienced liaison with internal partners in small business, wealth, commercial and…
Added 35 mins ago
Clinical Dietitian, Acute Care, Jefferson City
University of Missouri Health Care
Jefferson City, MO
· Identify and collect performance improvement data, monitor outcomes, and initiate corrective actions. Keep the manager informed about issues and problems impacting the work area. Assist…
Added 35 mins ago
Manager, 401(k) Client Services
ADP
Salem, NH
ADP is hiring a 401(k) Client Service Manager. Manages the day to day activities of a 401(K) client services team to ensure delivery of optimal service. Typically manages 10-12 401(k)…
Added 35 mins ago
Premier Banker- Concord North Main Street
TD Bank
Concord, NH
…products, offerings, and processes to fluently explain banking solutions to a client and to act as an experienced liaison with internal partners in small business, wealth, commercial and…
Added 35 mins ago
SAP - OTC - Manager - Consulting - Location OPEN
EY
Concord, NH
Experience facilitating client workshops, gathering business requirements, and translating them into scalable SAP solutions.
Added 36 mins ago
EG
Product Manager
Eliassen Group
Concord, NH
- $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 39 mins ago
J
Professional Services Operations Manager
Jobgether
Remote, United States
- $125,000 to $130,000 USD / year
Ability to work remotely using a government-imaged laptop and maintain availability during the federal client's standard office hours.
Added 39 mins ago
Senior Success Lead, Public Sector
Datavant
Remote, United States
Experienced strategic program and project manager focused on connecting the dots thinking that puts client value at the center of everything
Added 41 mins ago
Customer Adoption Manager, Large Law
FREEDOM SOLUTIONS GR
Raleigh, NC
As a Large Law Customer Adoption Manager, you make sure large law firms realize measurable value from Litera by embedding it into the day-to-day workflows of attorneys and business services…
Added 47 mins ago
CH
Program Administrator
Cayuse Holdings
Pukalani, HI
- $92,000 to $110,000 USD / year
Employment in this role is conditional upon successful execution of the contract by the client.
Added 47 mins ago
CH
Quality Program Manager
Cayuse Holdings
Pukalani, HI
- $165,000 to $198,000 USD / year
Employment in this role is conditional upon successful execution of the contract by the client.
Added 47 mins ago
CH
Mission Planner Operations SME
Cayuse Holdings
Pukalani, HI
- $165,000 to $200,000 USD / year
Employment in this role is conditional upon successful execution of the contract by the client.
Added 47 mins ago
CH
Mission Planner Operations SME
Cayuse Holdings
Pukalani, HI
- $150,000 to $190,000 USD / year
Employment in this role is conditional upon successful execution of the contract by the client.
Added 47 mins ago
CH
Quality Program Manager
Cayuse Holdings
Pukalani, HI
- $165,000 to $198,000 USD / year
Employment in this role is conditional upon successful execution of the contract by the client.
Added 47 mins ago
CH
Site Manager, Maui
Cayuse Holdings
Pukalani, HI
- $165,000 to $200,000 USD / year
The Site Manager will serve as the operational lead at the Maui client site, located on Mount Haleakala. This role is responsible for ensuring mission continuity, workforce integration, and…
Added 47 mins ago
CH
Site Manager
Cayuse Holdings
Pukalani, HI
- $165,000 to $200,000 USD / year
The Site Manager will serve as the operational lead at the Maui client site, located on Mount Haleakala. This role is responsible for ensuring mission continuity, workforce integration, and…
Added 47 mins ago
CH
Program Administrator
Cayuse Holdings
Pukalani, HI
- $92,000 to $110,000 USD / year
Employment in this role is conditional upon successful execution of the contract by the client.
Added 47 mins ago
Entry Level Account Manager - Houston, TX
MDL Career Site
Houston, TX
…individual to join our sales team. As an Entry Level Account Manager, you will be responsible for maintaining a large client base of existing customers for MDL and serve as a liaison…
Added 47 mins ago
Entry Level Account Manager - Houston, TX
Sales
Houston, TX
…individual to join our sales team. As an Entry Level Account Manager, you will be responsible for maintaining a large client base of existing customers for MDL and serve as a liaison…
Added 48 mins ago
SAP - OTC - Manager - Consulting - Location OPEN
EY
Honolulu, HI
Experience facilitating client workshops, gathering business requirements, and translating them into scalable SAP solutions.

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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