Quidelortho
TechnicalOperationsProcessEngineer
“Technical Operations Process Engineer at Quidelortho. Skills: process optimization, validation, continuous improvement. Execute process optimization, characterization and validation activities. Lead technical transfer projects from R&D to Manufacturing”
What You'll Achieve.
improve process performance; resolve issues; ensure product quality
Industry & Context.
analytical thinking and structured problem-solving capabilities; Ability to troubleshoot and resolve complex technical issues
handling of viral and bacterial hazards, potentially hazardous chemicals, infectious or potentially infectious bodily fluids, tissues and samples, Sitting, standing, walking, lifting, carrying, reaching, pushing, and pulling, bending, crawling, stooping, vision, grasping, climbing or balancing, kneeling, crouching, talking or hearing, use Personal Protective Equipment
What They're Looking For.
Must Have
Bachelor’s degree (BSA) in Engineering or related technical field, 3–5 years of experience in a cGMP-regulated manufacturing environment or equivalent, analytical thinking and structured problem-solving capabilities, Experience with process development, optimization, scale-up, and standardization, Proficiency in Design of Experiments (DOE), Statistical Process Control (SPC), and data analysis, Ability to independently design experiments, interpret data, and make data-driven decisions, Experience with process validation (IQ/OQ/PQ) and technical documentation, Knowledge of quality systems, cGMP regulations, and compliance requirements, project management skills with ability to manage multiple priorities and meet deadlines, Effective written and verbal communication skills, Ability to work both independently and collaboratively across cross-functional teams, Proficiency with standard computer applications (e. g. , Microsoft Office, data analysis tools), Ability to troubleshoot and resolve complex technical issues with minimal supervision, organizational skills and attention to detail, Demonstrated ability to drive continuous improvement initiatives, Capable of working in a fast-paced, regulated manufacturing environment
Nice to Have
Six Sigma certification (Green Belt or Black Belt)
What You'll Do.
Execute process optimization
characterization and validation activities
Lead technical transfer projects from R&D to Manufacturing
Own investigations for NCs
Design and analyze DOE implement data-driven improvements
Develop process and material specifications
Author and revise technical documentation
Execute change plans from feasibility assessment through implementation
Support supplier qualification activities
Contribute to continuous improvement initiatives
Ensure compliance with QMS and regulatory requirements
Perform other work-related duties as assigned
How You'll Work.
Team & Collaboration
alignment with cross-functional stakeholders; work both independently and collaboratively across cross-functional teams
Communication Scope
Effective written and verbal communication skills
Process & Methodology
project management skills with ability to manage multiple priorities and meet deadlines, Lead portions of technical transfer projects
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