Continuous Improvement Engineer (Deviations)
Perrigo Company is dedicated to making lives better by bringing high quality and affordable self-care products that consumers trust everywhere they are sold. Help us do it.
- Provides technical support as it relates to product incident/deviation investigations.
- Applicants ideally will have had experience within the pharmaceutical or food processing industries and be able to demonstrate a sound knowledge of Good Manufacturing Practice within this environment.
- Coordinates the investigation and follow-up processes for assigned site(s) using various analytical tools (FMEA analysis, Ishikawa diagrams, etc.) in collaboration with the appropriate departments
- Evaluates product quality through deviation trend analysis to ensure products and processes are consistently produced within their quality attributes.
- Coordinates the investigation and follow-up processes for assigned sites/locations using various analytical tools (FMEA analysis, Ishikawa diagrams, etc.) in collaboration with the appropriate departments, outside vendors and contract manufacturers.
- Prepares investigations and incident reports and recommends corrective actions as necessary for all product and process issues and ensures timely completion of all investigations and corrective actions.
- Recommends disposition of all involved product to the Quality Unit.
- Collaborates within cross-functional project work groups.
- Bachelor’s degree required - preferably in engineering, chemistry, pharmaceutical sciences or related field.
- 1-3 years of experience in this field is required.
- Familiarity with cGMP, FDA regulations, including experience with investigations and/or developing and recommending process improvements.
- Knowledge of principles, concepts and practices in pharmaceutical sciences and manufacturing processes.
- Well-developed interpersonal, organization and communication skills, ability to work effectively with staff members at all levels, strong technical writing skills, familiarity with cGMP and FDA regulations.
- Computer literacy with a working knowledge Microsoft Office (Excel and Word), and SAP experience preferred.
- Ability to work independently on multiple concurrent projects with minimal guidance and to meet project deadlines.