COMPANY: This company was founded over three decades ago and has pioneered and focused on areas of high unmet
medical needs. They have leveraged their expertise to strive for solutions that improve health outcomes and dramatically
improve people’s lives. They have become one of the world’s leading independent biopharmaceutical companies.
DUTIES: The Principal Engineer
in Process Development (PD) will report to the Director of Packaging Engineering and Labeling. He, or she, will develop
annual goals and strategic direction for the packaging organization to the Final Product Team Lead (FPTL). The Principal
Engineer will identify and drive efficiencies and utilization of the commercialization process, the lifecycle of products,
and the overall manufacturing capability of company operations across the global networks. The successful candidate for
this position will lead a team of engineers responsible for the clinical and commercial packaging for drug substance,
drug product, primary container closures and final product presentations. The candidate will help create and
implement the long-term strategy to ensure that the Company becomes and remains an industry leader in this area. They will
work cross functionally as a Device Technology Lead (DTL) within PD and across the Company to develop products that create
a successful patient experience.
- Drive continuous improvement in the packaging processes from project initiation
through launch as well as life cycle management. In alignment with regulatory and commercial manufacturing requirements.
packaging technologies that will drive innovation and gain efficiencies in the network
- Design, qualification
and implementation of packaging designs
- DTL lead for molecule programs driving packaging strategy and
milestone to the PDT
- Consistently deliver results aligned with departmental and program goals.
- Develop and maintain a high performing team of engineers, with advanced degrees and experience in packaging
engineering that are professionally and technically competent.
- Be a role model in living the
Company values and leadership attributes.
- Identify resource requirements to deliver on program portfolio
and negotiate resource assignments from leadership.
- Deliver progress reports and presentations ensuring
that management is aware of the current status, progress and future needs within Operations.
- Identify and
ensure area of responsibility complies with the most current standards and company policies.
regulatory documents in support of molecule applications.
- Provide leadership and guidance to
ensure consultants, contract manufacturers, and external business partners comply with business standards and
Bachelor’s Degree in Packaging and 8 or more years of Packaging
and/or Mechanical Engineering experience with 3-4 years within the pharmaceutical or
biotechnology area. Master’s
degree and 6 years of Engineering experience.
- Master’s degree in Engineering,
Science or related technological field with 5 years of work experience, with previous experience in the pharmaceutical
or biotechnology area.
- Proven ability to manage and deliver results in a highly fluid, interactive matrixed
- 10 years of packaging engineering experience in a site and/or corporate engineering
environment, with specific specialized expertise in operations and packaging design.
- 3 years managing
- 3 years of experience in executing packaging engineering projects (cross functional team
managing departmental or functional level projects: approving resources, assigning tasks, presenting milestones, cost/benefit
- Strong communication, relationship building, leadership and mentoring skills.
- AutoCad or similar software application to create, modify and approve engineering drawings.
- Demonstrated ability to lead teams to successful project results within established time guidelines.
- Excellent leadership, project management, technical problem solving and communication (written and verbal)
skills, and the ability to manage remote people, work in teams and adapt to rapidly changing environment.
- Demonstrated leadership in a wide range of packaging related technologies with strong fundamental knowledge
of primary and secondary packaging systems and processes, manufacturing process equipment and processes, material
science, and quality systems.
- Excellent organizational, project management, technical, problem
solving and communication (written and verbal) skills.
- Demonstrated ability to work with
a range of technically and culturally diverse people, influencing them to get the job done, and delivering value-added
business results that meet high quality requirements within a tight schedule.
Quality Search, 1820 Graham Drive
• Chesterton, IN 46304-1627 • (219) 926-5015 • www.qsjobs.com
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Must be a United States citizen or lawful permanent resident or have authorization to work in the