Jobs in the United States

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Added 39 mins ago
Certified Sterile Processing Tech
AdventHealth
Ocala, FL
Monitors and maintains adequate levels of surgical supplies and instruments. Communicates daily instrument needs with Sterile Processing staff. Picks and prepares instrumentation and…
Added 1 hour ago
Dentist - Oral & Maxillofacial Surgery
Veterans Affairs, Veterans Health Administration
Washington, DC
Added 2 hours ago
CE
Sales Associate
Claires Essentials LLC
Coralville, IA
- $10.5 to $11.5 USD / hour
…conducting piercings, educating on aftercare, maintaining a sterile environment, addressing questions and concerns throughout the…
Added 2 hours ago
DH
Technologist, Surgical Services (Certified)- Inpatient
Denver Health
Denver, CO
- $29 to $42 USD / hour
…procedures. Transports patients. May be assigned to work in the sterile processing department and/ or operating room as required. Under the close supervision of a qualified surgeon, the…
Added 5 hours ago
Pharmacist (Facility Program Manager - Compounding & Management of Hazardous Drugs)
Veterans Affairs, Veterans Health Administration
Johnson City, TN
Added 6 hours ago
Manager, Business Operations PAT, DOSA, OR, PACU, GI, Sterile Processing RGH
RochesterRegional Health
ROCHESTER, NY
Added 6 hours ago
NL
Assistant Manager-Kimmel Pavilion SPD-Day Shift (35 Hours)
NYU Langone Medical Center
New York, NY
- $66,299.99 to $95,400 USD / year
…stocks medical disposable goods in storage areas and ensures sterile processing of all materials. Provides guidance and monitor quality of work assignments for Supply Assistants and Supply…
Added 7 hours ago
DH
Medical Assistant (MA) - Westside Adults PRN
Denver Health
Denver, CO
- $21 to $26.26 USD / hour
…provider in setting up for procedures including aseptic and sterile techniques; provides safe administration of medications and immunizations (oral, IM, subcutaneous, and/or intradermal);…
Added 7 hours ago
Sterile Processing Manager
Ascension Health
Evansville, IN
Lead and mentor the sterile processing team, fostering high engagement, accountability, and seamless daily operations across staffing, training, and performance management.
Added 8 hours ago
Central Supply Sterile Processing Supervisor
University of Michigan
Ann Arbor, MI
The Supervisor oversees the afternoon central sterilization staff, ensures effective instrument processing, and addresses staffing issues. This role includes assisting the manager with…
Added 8 hours ago
Sterile Processing Supervisor - Troy
University of Michigan
Ann Arbor, MI
To plan, prepare, coordinate and supervise the sterile instrument processing functions and activities for Central Sterile Processing Department.
Added 10 hours ago
Manager, Engineering
Merck
Millsboro, DE
The Engineering Manager will provide strategic and tactical engineering leadership for the Millsboro facility, supporting safe, compliant, and reliable operation of production and utility…
Added 12 hours ago
SPD Tech
Yale New Haven Health
Trumbull, CT
High school graduate or equivalent. A Current "Sterile Processing Distribution Technician Certification" from CBSPD or IAHCSMM.
Added 12 hours ago
Sterile Processing Tech
Kennestone Hospital, Inc.
United States
The Sterile Processing Technician provides a key service WellStar to ensure equipment consistently meets the highest quality and safety standards. The individual in this role must be…
Added 14 hours ago
Emergency Room Tech
HMC
Flint, MI
Retrieves emergency equipment from other departments and cleans equipment before sending to sterile processing.
Added 14 hours ago
Emergency Room Tech
HMC
Flint, MI
Retrieves emergency equipment from other departments and cleans equipment before sending to sterile processing.
Added 15 hours ago
OC
Sterile Processing Technician - Full Time - St. Mary Campus
Ochsner Clinic Foundation
Houma/Raceland Region, LA
- Full-time
…performs other duties as assigned by the SPD Supervisor or Manager of Sterile Processing. Responsibilities include, but are not limited to, receiving, cleaning, distributing, and storing…
Added 17 hours ago
BH
OR Service Coordinator (ENT/Plastics/Urology
Baptist Health
Lexington, KY
- $7.25 USD / hour
…Endoscopy Department with dedicated pre- and post-op areas, and a Sterile Processing…
Added 17 hours ago
BH
OR Service Coordinator (CT/Vascular)
Baptist Health
Lexington, KY
- $7.25 USD / hour
…Endoscopy Department with dedicated pre- and post-op areas, and a Sterile Processing…
Added 17 hours ago
Unit Secretary/Nursing Tech - Post Surgical
Presbyterian System Services
United States
Coordinates and maintains specific equipment and / or supply systems. Coordinates and maintains specific sterile processing systems
Added 17 hours ago
Sterile Processing Manager
Ascension
Evansville, IN
Lead and mentor the sterile processing team, fostering high engagement, accountability, and seamless daily operations across staffing, training, and performance management.
Added 18 hours ago
Technician II, Central Sterile Processing
Kaiser Permanente
Atlanta, GA
Under direct supervision of the Sterile Processing Department Manager or Supervisor, performs decontamination, preparation & packaging, sterilization or high level disinfection of reusable…
Added 18 hours ago
Process Engineer/Senior Process Engineer
Kymanox
Morrisville, NC
…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…
Added 18 hours ago
Sterile Processing Specialist - PRN
Akron Children's
Akron, OH
The Sterile Processing Specialist is certified in the process and is responsible for a combination of the following functions: decontamination, cleaning, assembly and sterilization of all…
Added 19 hours ago
DH
Medical Assistant (MA) - Pena
Denver Health
Denver, CO
- $21 to $26 USD / hour
Assists provider in setting up for procedures including aseptic and sterile techniques; provides safe administration of medications and immunizations (oral, IM, subcutaneous, and/or…

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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