Principal Engineer, Packaging (9-12 Month Contract)

BioCT Innovation Commons; Danbury (CT); On-site; USD 80,000 - 110,000; Full time

Job summary

BioCT Innovation Commons in Danbury, Connecticut is seeking an experienced Packaging Engineer to oversee end-to-end packaging technology projects for pharmaceutical products. You will work with development teams to determine packaging specifications and ensure compliance with regulatory standards.

The ideal candidate will have a BS in Package Engineering and significant experience in the pharmaceutical sector. Strong organizational and analytical skills are essential, as well as knowledge of materials testing methodologies.

Qualifications

• 10-15 years of package engineering experience with a BS or 8-10 years with an MS.
• Strong knowledge of packaging regulations and testing methodologies.
• Ability to manage multiple packaging projects simultaneously.

Responsibilities

• Design and develop packaging for pharmaceutical products.
• Create regulatory and purchasing specifications for packaging.
• Coordinate packaging launch activities for new products.

Skills

Organizational skills

Regulatory knowledge (cGMP)

Material testing knowledge

Analytical skills

Education

BS Degree in Package Engineering

MS with package engineering experience

Job description

Job Summary

Responsible for end to end 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 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:
  • Critical drug product attributes as defined by Development teams
  • Commercialization requirements set by Marketing
  • Regulatory needs supporting NDA submission, review and approval
  • 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.
• 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 investigation reports in support of package components, materials, equipment and processes.
• Responsible for observing all Company, Health, Safety and Environmental guidelines.
• Duties and responsibilities are not limited to the work listed above and may include other assignments as necessary.

Minimum Qualifications

• BS Degree in Package Engineering with 10-15 years or MS with 8-10 years of related experience in package engineering in pharmaceuticals or the equivalent combination of training and experience.
• 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.