Address
Form of workPurpose
The Senior Engineer will support technical operations in our Packaging department for the Waco, Texas site. This individual will perform all activities related to new and changes to current packaging components from review of drawings, bringing components into the facility, through the process to change control and, where required, qualification activities.
Responsibilities
- Review all proposed changes by vendors and coordinates required activities with above site (IM&E, S&T), and site Quality, Operations and Planning/Supply Chain units.
- Provide risk assessments required for change controls that determine qualification requirements for new and/or changes to current components.
- Assist with implementing new components and changes to current components and packaging processes into Operations.
- Serve as a SME for packaging at the site. Own and execute change controls related to packaging components.
- Troubleshoot issues related to packaging components and working with Operations, Quality, and vendors to reduce/eliminate issues. Work with Operations and component vendors to reduce/eliminate downtime due to packaging component issues.
- Independently plan and conduct small- to medium-size assigned projects within engineering specialty requiring conventional types of plans, investigations, and/or equipment. Manage multiple, often concurrent, projects and meets deadlines.
- Manage non-conformance, corrective/preventative action GTW records related to packaging components.
- Actively participate in the resolution of supplier quality issues.
- Provide technical guidance and may participate in the evaluation of assigned staff/project team members and in the identification of development needs. May supervise other engineers or technicians.
Qualifications
- Bachelor's Degree in Engineering, Packaging, the sciences, or closely related discipline is desired, or equivalent technical experience plus demonstrated competence in engineering and/or operational experience.
- 5 years of relevant engineering and/or operational experience, with an emphasis in Packaging Engineering preferred.
- Proficiency in MS Office, TrackWise, AutoCAD, and MS Project.
- Possesses a strong technical knowledge and application of concepts, practices, and procedures.
- Ability to preform risk analysis and assess data to help drive required technical service needs, compliance, and process improvement initiatives.
- Experience in manufacturing/packaging of pharmaceutical products. Experience working in a GMP regulated environment highly preferred.
- Knowledge of FDA regulated industrial environment preferred.
- Works well with other engineers in a collaborative, fast-paced goal-driven environment.
