Manager Senior Packaging Engineer

Location: Swiftwater, PA

The role of the Manager Sr. Packaging Engineer involves identifying, and resolving compliance, and efficiency issues that impact the Secondary Packaging Operations in Swiftwater, PA. This position actively contributes as a member of cross-functional teams, serving as an interface between the FFIP platform, maintenance, engineering and the Technical Community. The Sr. Packaging Engineer is responsible for all activities related to the Continuous Improvement of Packaging for Drug Products and process monitor program. As an individual contributor within the organization, the role encompasses membership in cross-functional teams supporting continuous improvement for packaging with a focus on Secondary Packaging operations. Additionally, the Sr. Packaging Engineer provides project support for cross-functional teams, serving as the area interface for addressing Packaging processes, operations and project-related issues.

We are an innovative global healthcare company that helps the world stay ahead of infectious diseases by delivering more than 500 million vaccine doses a year. Across different countries, our talented teams are exploring new technologies to protect people and promote healthy communities. We chase the miracles of science every single day, pursuing progress to make a real impact on millions of patients around the world.

Main Responsibilities:

• Provides technical supports to Engineering, Maintenance, Quality Supplier, Quality Assurance (QA), and Quality Validation (QV)

• Working knowledge of packaging materials specifications, Serialization, 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/mentor new and existing engineers, managers and maintenance personnel on packaging programs that include formats/ID’s creation, troubleshooting and packaging sterilization, 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, process monitor 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.

About You

Basic Qualifications:

• B.S. in electrical, mechanical and/or other applicable engineering field required.

• 2-5 years of experiences in pharmaceutical, biotech, food, medical Device in manufacturing, maintenance, and engineering or other industries will be considered.

• At least 1-year experiences working with packaging equipment/component in a pharmaceutical cGMP or food industry environment or other industries will be considered.

• Functional experience with packaging equipment/component and process monitor.

• 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.

Why Choose Us?

• Bring the miracles of science to life alongside a supportive, future-focused team.

• Discover endless opportunities to grow your talent and drive your career, whether it’s through a promotion or lateral move, at home or internationally.

• Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact.

• Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs and at least 14 weeks’ gender-neutral parental leave.