At Eisai, satisfying unmet medical needs and increasing the benefits healthcare provides to patients, their families, and caregivers is Eisai's human health care (hhc) mission. We're a growing pharmaceutical company that is breaking through in neurology and oncology, with a strong emphasis on research and development. Our history includes the development of many innovative medicines, notably the discovery of the world's most widely-used treatment for Alzheimer's disease. As we continue to expand, we are seeking highly-motivated individuals who want to work in a fast-paced environment and make a difference. If this is your profile, we want to hear from you.
Essential Functions
- Accountable for the oversight of onsite activities to support packaging equipment projects and initiatives related to primary and secondary packaging of commercial products as well as other pharmaceutical manufacturing steps.
- Accountable for establishing and maintaining relationships with peers at CMOs, Eisai network sites, strategic business partners engaged in packaging of Eisai products.
- Responsible for the successful implementation of packaging equipment changes, site / manufacturer changes, facility improvements and/or equipment enhancements, including cleaning verifications/validations and provide support / troubleshooting during investigations related to packaging or equipment matters.
- Provide technical expertise related to packaging CMO identification selection for packaging transfers of existing products, acquisition of new products and new pipeline products.
- Accountable for the successful introduction of new product packaging and existing product transfers at CMOs.
- Supports packaging project plans assuring integration and achievement of needs from cross-functional stakeholders including Supply Operations, Quality (EMQO), Global Labeling, Regulatory Affairs are included to achieve desired outcomes on-time and on-budget.
- Highly knowledgeable in the design and execution of equipment protocols (IQ, OQ, FAT, PQ, etc.) associated with introduction of new equipment or new product introduction to existing production lines equipment.
- Knowledgeable and experience with packaging component design with materials such as paperboard, adhesives, inks, glass, plastics, metal, films, labels, and cartons.
- Accountable for compliance of packaging processing operations against registered details (where applicable), industry standards and internal company policies.
- Applies knowledge and experience as a Subject Matter Expert (SME) across and beyond the boundaries of packaging equipment.
Requirements
Education:
Bachelor of Science in a relevant engineering discipline (e.g., Mechanical, Electrical, Industrial), or a related field (preferred) or BS degree with commensurate experience (required)
Technical:
- 5+ years' experience directly supporting packaging operations. Hands-on experience with a variety of equipment types, in a pharmaceutical, or regulated industry, company in engineering and operations support type roles.
- Broad knowledge of relevant FDA, International Council for Harmonization (ICH), and EU guidelines coupled with the ability to interpret, apply guideline principles and regulations to ensure compliance.
- Ability to operate effectively and influence decision-making in a dynamic, multi-cultural, international environment.
- Demonstrated commitment to continued skills development through on-the-job and/or other continued professional development opportunities also preferred.
- Experience with Microsoft tools/software.
Must Possess:
- Ability to communicate effectively and efficiently using verbal, presentation, and written communication skills to build and foster relationships; good interpersonal communication skills;
- Capability to work with diverse teams in demanding environments where resources and time may be limited
- Must be self-directed, goal-oriented, quality conscious and team focused; able to work independently with minimal supervision.
- Experience authoring and reviewing technical documents
- Aptitude to operate in a clear, decisive manner and reach independent, sound solutions during normal and time-critical situations
- Strong, demonstrated negotiation skills
- Knowledge of and familiarity with project management
- Ability to rapidly see the big picture and assess the impact of data and/or decisions
- Travel (domestic and global) 40% or more may be required
- Core values in alignment with the Eisai Values (Integrity, Respect, Professionalism, Quality and Teamwork) together with an intrinsic understanding of Eisai's hhc Mission and the need to always think first of the Patient.
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Eisai is an equal opportunity employer and as such, is committed in policy and in practice to recruit, hire, train, and promote in all job qualifications without regard to race, color, religion, gender, age, national origin, citizenship status, marital status, sexual orientation, gender identity, disability or veteran status. Similarly, considering the need for reasonable accommodations, Eisai prohibits discrimination against persons because of disability, including disabled veterans.
Eisai Inc. participates in E-Verify. E-Verify is an Internet based system operated by the Department of Homeland Security in partnership with the Social Security Administration that allows participating employers to electronically verify the employment eligibility of all new hires in the United States. Please click on the following link for more information:
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