Job Title: Packaging Engineer - Pharmaceutical / Biotech Industry
Location: Danbury, Connecticut

Industry: Pharmaceutical / Biotech
Job Category: Engineering - Industrial / Manufacturing

 
Responsible for Package Technology projects necessary to design, develop and transfer cost
effective and sound packaging for pharmaceutical products.  Determines packaging specifications
according to the nature of the product, cost limitations, legal requirements, and the type of
protection required, considering need for resistance to such external variables as moisture, corrosive
chemicals, temperature variations, light, heat, handling and tampering. 
 
 
Essential Responsibilities / Duties
 
Works on complex problems in which analysis of situation or data requires an in-depth evaluation of
various factors.  Exercises judgment within broadly defined practices and policies in selecting
methods, techniques and evaluation criteria for obtaining results. May determine methods and
procedures on new assignments and may provide guidance to other lower-level personnel.  Interacts
in a team environment as part of the development, transfer and launch project structures, as well as
required to work independently on the technical and regulatory tasks necessary to support
corporate and team goals. 
 
 Design drug product packaging in support of the drug development process by identifying:
o Critical drug product attributes as defined by Development teams

o Commercialization requirements set by Marketing
o Regulatory needs supporting NDA submission, review and approval
o Production efficiencies and standards as necessary
 Develop packaging technologies using engineering principles and scientific analysis to collect
and synthesize data relating to package and drug product performance.
 Implement package design solutions in a commercial environment, by leading &
coordinating project activities, including equipment selection, procurement and qualification
and logistics associated with contract packaging sites.
 Support clinical supply activities by designing appropriate drug product packaging.
 Scale up packaging technologies to production by compiling and executing the necessary
technical and financial plans.
 Write, create and establish regulatory and purchasing specifications for packaging
requirements (components, in process controls) based upon development and transfer
activities.
 Coordinate and participate in the launch activities related to packaging which are required
to support new product introductions.
 Lead and participate in project teams as required utilizing good communication, analytical,
organizational and leadership skills.
 Generate written development and investigational reports in support of package
components, materials, equipment and processes. Duties and responsibilities are not limited
to the work listed above and may include other assignments as necessary.
 
Qualifications
 
 BS Degree in Package Engineering or related field, with a minimum 5-8 years’ experience in
package engineering in pharmaceuticals or related field, or MS degree with 3-6 years’
experience in package engineering in pharmaceutical or related  field. 
 Working knowledge of materials test methodology, laboratory procedures and packaging
equipment.
 Strong organizational skills and ability to manage multiple responsibilities.
 Knowledge of cGMP’s and various regulatory aspects affecting pharmaceutical packaging
development and operations.
 
Skills and Certifications [note: bold skills and certification are required]
Packaging Engineer
5 years' experience
Pharmaceutical experience highly preferred

Security Clearance Required: No
Visa Candidate Considered: No