Project Area Specialist - Project Qualit - United States
- For more than 90 years, we have led the way in diabetes care. Being part of our company allows our employees to embark on life-changing careers, and the opportunity to help and improve the quality of life for millions of people around the world.
- To help meet the growing demand for our diabetes treatment, our company expects to double production of diabetes drugs over the next decade.
- The new plant will initially employ 700 employees to produce the active ingredients for a new diabetes oral treatment and a range of other diabetes drugs.
- Our company is currently seeking top talent for this green field project and eventual operations.
- This once in a life-time career opportunity is ideal for manufacturing professionals who not only understand the operational complexities of manufacturing but also have the desire and drive to help us design and build.
- Here you will work with the best manufacturing professionals in the industry, while learning and taking part in the plant design.
- Project Area Specialist in the DAPI-US Project.
- Experienced Project Area Specialist within project quality that can drive implementation of our company Quality Concept in the project work packages.
- Build understanding of the DAPI-US Quality Concept.
- Provide knowledge about HP Quality Center.
- Support ad hoc tasks & challenges within Quality Concept & HP Quality Center.
- Implement relevant work processes within the work package in DAPI-US project.
- Alignment of work & quality processes within work packages.
- Participation in alignment of work & quality processes.
- Identify & implement improvements that support lean project execution.
- Build strong relations to work packages in our company project organization.
- Responsible for training new employees in HP Quality Center modules.
- Support one or more production/quality tracks (including but not limited to Warehouse, Automation, Fermentation, Purification, Recovery, &/or Site Services).
- Support/advise employees with technical problem solving regarding HP Quality Center.
- Maintain relevant activities in HP Quality Center.
BA/BS in related field or equivalent combination of education & experience combined with other relevant pharmaceutical technical education.
- 5+ years of directly relevant work experience.
- 3+ years of experience with facility & equipment validation.
- Knowledge of electronic document validation system.
- Understanding of lean project execution principles, continuous improvements & the application in a project environment.
- Quality & validation experience.
- HP Quality Center experience.
- Project execution knowledge & the ability to link/translate validation procedures & principles to practical hands on project works processes.
- Written & verbal communication skills to allow efficient interaction with all members in the work packages.
Physical & Other Requirements:
- Ability to work in & around an active construction site during project phase.
- Ability to work in confined spaces & near operating equipment.
- Ability to work in loud noise environments.
- Ability to travel internationally.
- Ability to work flexible hours to support international delivery team.
- Comfortable working independently.