Jobs and Careers

Sr. Manufacturing/Process Engineer

Morrisville, United Statesfull_timeVerifiedPosted 3 Jan 2025

About the role

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