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.
This Sr. Manufacturing/Process Engineer position provides senior technical support for manufacturing systems and processes across all areas of Life Sciences including pharmaceutical, biotechnology, cell & gene therapy, medical devices, and radiopharmaceuticals.
We are seeking an experienced engineering professional to lead initiatives related to facilities, utilities, equipment, and processes in a cGMP (current Good Manufacturing Practice) manufacturing environment. The ideal candidate will have demonstrated, hands-on (shop floor) expertise in the design, implementation, and improvement of manufacturing systems and processes. This role will require strong leadership, technical skills, and a deep commitment to ensuring compliance with cGMP standards, particularly in change management.
Responsibilities
Project Engineering
- Directly and/or indirectly perform project management roles for projects assigned within primary focus areas.
- Support operational readiness and commercial manufacturing start-up.
- Support the planning, designing, installation, and maintenance of manufacturing systems and processes.
- Support the implementation or improvement of manufacturing programs (engineering, calibration, maintenance, etc.).
Commissioning
- Develop requirements and specifications for facilities, utilities, equipment, and computerized systems.
- Equipment selection and cost estimation including authoring of Requests for Proposals (RFPs) and submission to vendors for quoting.
- Manage equipment vendors from quotation through equipment installation.
- Support system installation, startup, and optimization.
Operational Excellence
- Support Operational Excellence programs including process mapping, continuous improvement, standardized work, lean manufacturing, and/or lean six sigma.
- Observe equipment on the manufacturing floor to identify, investigate, and remediate causes for equipment downtime, inefficiencies, and process deviations.
- Utilize key performance indicators (KPIs), data analytics, and trending tools to assess equipment efficiency and process reliability.
- Prepare and present detailed reports on findings, actions taken, and outcomes achieved.
cGMP Compliance & Change Management
- Ensure all modifications to systems and processes are conducted in compliance with cGMP regulations.
- Manage change control documentation and processes, ensuring proper approvals and risk assessments are completed.
- Partner with Quality Assurance to ensure all changes maintain product integrity and regulatory compliance.
Training & Standardization
- Develop or modify and implement standard operating procedures (SOPs) to maintain consistent operations and minimize variability.
- Train and mentor team members and production staff on SOPs and operation of systems.
Cross-Functional Collaboration
- Work closely with Engineering, Manufacturing, Maintenance, Quality, and Supply Chain teams to ensure alignment project on requirements and execution.
- Serve as a key technical advisor and problem solver for cross-functional teams.
Educational Background
- The ideal candidate will have a bachelor’s degree in science or engineering related disciplines, such as Chemical, Mechanical, Electrical, Biomedical, or Manufacturing Engineering.
Experience
- Minimum of 7 – 10 years of engineering experience in a cGMP pharmaceutical, biotechnology, cell & gene therapy, device, radiopharmaceutical, or similar regulated environment (this includes post graduate experience). Must have some hands-on experience.
- Experience in aseptic processing.
- Proven experience in project execution and commissioning, troubleshooting, and optimization of systems.
- Experience implementing continuous improvement of processes and systems is desired.
- Knowledge of with Building Management Systems (BMS), Environmental Monitoring Systems (EMS), Manufacturing Execution Systems (MES), and Maintenance programs and Computerized Maintenance Management Systems (CMMS) is desired.
- Strong understanding of cGMP regulations, quality systems, and change management processes.
- Exceptional analytical, problem-solving, and communication skills.
- Demonstrated ability to lead cross-functional teams.
Travel:
Up to 50% travel is possible for onsite project support. A passport is required for this job.
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 90 days 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, and we have offices in Boston, Chicago, Philadelphia, and New Jersey.
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.
