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: This position reports
into the Packaging Engineering group under Final Product Technologies. The position will support global supply, new product
introductions, partnerships/acquisitions and combination products.
This position utilizes physics, engineering and chemistry principles
coupled with advanced and diverse materials science understanding and principles to assist in the evaluation, design,
qualification and implementation of packaging components and the associated systems such as documentation, equipment and
- Lead and present new packaging ideas, concepts and design ideas to the Product Development team.
- Representing Final Product Technologies as required
- Technology transfer from clinical
to commercial or from site to site for packaging components and equipment processes
- Management of
entry level engineers and contingent workers.
- Evaluation, recommendation and selection of new
packaging materials for both large and small molecules product.
- Assessing complex problems relating
to materials, recommending and implementing solutions
- Write test protocols, perform technical
evaluations and submitting technical assessment reports to justify the use of selected materials.
- Establish priorities to ensure all projects are managed within expected due dates
- Ensures cGMP and regulatory compliance are met
- Ensures that change control procedures
are followed working with QA and
- Regulatory to implement changes
- Participants in Pre-Approval
Inspections (PAI) and interact with regulatory bodies (e.g., FDA, EMEA, etc) as needed
with cross-functional teams (i.e. Research, QA/QC, Supply Chain, Maintenance, Manufacturing, Regulatory, etc.)
in pre-commercial and commercial activities.
Degree in Packaging and 5 or more years of Packaging and/or Mechanical Engineering experience with 3-4 years within the Pharma/Bio industry.
- Leading teams
- Independent thinker with demonstrated
skills working in teams or leading project teams
- Strong Interpersonal and communication skills
of common materials utilized in pharmaceutical packaging is key to this role. Key Material knowledge requirements of the
structural components and chemical properties of glass, polymers, adhesives, inks, varnishes and paper is integral in the
day to day oversight of this role. Understanding of packaging manufacturing equipment and processes and how materials
interact with these is essential to the position. This role will have some entry level management potential and the successful
candidate will also utilize excellent organizational, project management, technical problem solving and communication (written
and verbal) skills, with the ability to work in teams and adapt to a rapidly changing environment.
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