Package Engineer – Ortho Clinical Diagnostics – Raritan, NJ, USA
We are recruiting for a Package Engineer who will be responsible for technical support for Line Engineering function for all Ortho components as well as the overall quality, compliance and improvement of packaging components/raw materials. Major responsibility is to manage projects/activities as identified by Management to include manufacturing process improvement, certification, validation, change control, closure integrity, design/artwork changes, cold chain, technology transfer, capacity increases etc. This position is also responsible for improvement activities/nonconformances and associated corrective/preventive actions in support of Manufacturing Issues.
- Manage changes through the change control process
- Coordinate nonconformance investigations and preventive actions
- Apply Six Sigma tools to drive supplier certification goals and quality improvements
- Lead and execute Installation, Operational and Performance Qualifications for equipment, component, material, process changes and capacity increases
- Participate on teams to improve manufacturing process performance and total delivered cost
- Component Tolerance Verification
The Individual: The qualified candidate will have a minimum requirement of a Bachelor’s degree in Engineering and (2 – 4) year’s equivalent experience in Chemical/Industrial/Package Engineering or Supply Chain. Candidates who possess a Six Sigma Methodology Certification or working knowledge of Process Excellence Tools and statistical software are preferred for this role. Individual should have experience with equipment, component, process and product validations to include Installation, Operational &Performance Qualifications and Obsoleting components/equipment. Project Management and experience conducting root cause/failure investigations are also required.
This position also requires strong written and verbal communication skills, and working knowledge of ISO and QSR regulations. Proficiency with MS Office Suite of applications is required. The candidate will also be a strong team player, required to work across organizational/external functions, be results oriented and have excellent problem solving skills.
- Must be able to perform work tasks and operations in compliance with safety rules and regulations.
- Attend applicable safety educational and training programs, participate in Safety Committees.
- Immediately report and correct, if possible, unsafe conditions and near miss incidents.
- Conduct self-inspections of work stations and offices for hazardous conditions.
- Include safety-related activities and accomplishments in their performance appraisals, as applicable.
Job requires normal physical demands including good eyesight. Must be capable of lifting 40 lbs. and be able to meet requirements for access to manufacturing areas, packaging manufacturers or other facilities where package components are produced, used or tested. Less than 10% travel is required.