Manager – Continuous Improvement Packaging Engineer

Manager – Continuous Improvement Packaging Engineer

Requirements

• Bachelor’s degree in engineering and/or any other degree with at least 3 years working as a Packaging Engineer required.
• 1-3 years experiences working with equipment/component in a pharmaceutical cGMP, Medical Devices or food industry environment or equivalent.
• Understanding of Code of Federal Regulation (21 CFR Part 210 & 211) guidance regarding Packaging Operations.
• Requires 100% on-site present during normal workdays and willing to provide support during the off-shit hours occasionally that include remote or on-site.
• Experience in customer support, operational excellence, and troubleshooting.
• Must have good written and verbal communication skills, as well as the ability to actively, and cooperatively work with cross functional teams.

Responsibilities

• Provides technical supports to Shopfloor Personnel, Quality Assurance (QA), and Quality Validation (QV)
• Working knowledge of packaging materials specifications, packaging formats/ID’s creation, packaging equipment and component troubleshooting.
• Responsible for the Process Monitor program for the Packaging department, that includes tracking of reconciliation data, initiates excursion reports as needed and presents data to the team monthly.
• Responsible to train shopfloor personnel on new and existing equipment, managers and maintenance personnel on packaging programs that include formats/ID’s creation, and troubleshooting etc.,
• Provide support to shopfloor managers on packaging component, equipment and operations.
• The ability to work independently or with other group to identify packaging issues, formulate solutions and implement changes as needed.
• Utilizing the ‘+QDCI’ Visual Management Systems and working with the FFIP Management Committee to drive improvements in key metrics.
• Ensure compliance with all regulatory requirements and good documentation are followed to provide a safe, quality, and effective finished product.
• This position will support both the needs of packaging as well as project related activities.
• The position will also require evaluation of packaging operation performance and finding ways to improve OEE and reduce equipment downtime.
• Having a strong working knowledge of the relationship between packaging component, and equipment characteristics and all critical quality attributes.
• Coordinate project validation approach with Packaging Personnel, Engineering, Maintenance and Site Quality Operations.
• Strong customer communication and the ability to work with multiple groups to complete projects for new and existing packaging formats within the FFIP.
• This position will have interactions with Health, Safety and Environment (HSE), Engineering, Site Quality Operations, Information Technology & Solutions, Outside Contractors/Consultants, Vendors, Industrial Operations and Research & Development departments.
• Leading tactical responses to equipment/component/process monitor related excursion, Agency observations, delivering technical solutions and communicating outcomes to site management.
• Review/approve process design specifications, technical documents, validation project plans and assist on the execution of equipment/component validation.
• Author / review / execute/ approve technical documents which support equipment/component testing.
• Author Change Control which supports equipment/component related changes and project works.
• Promote innovation to keep up to date with the latest regulatory expectations, Technology, and industry standards.

Preferred Qualifications

No preferred qualifications provided.