Principal Engineer, Packaging (9-12 Month Contract)

Mannkind Corporation; Danbury (CT); On-site; USD 76,814 - 115,236; Full time

Job summary

A pharmaceutical company located in Danbury, CT is looking for a Principal Engineer, Packaging for a 9-12 month contract. The role involves designing and developing effective packaging solutions, ensuring compliance with regulatory standards, and supporting drug product packaging. Applicants should have a BS degree in Package Engineering with a significant amount of relevant experience in pharmaceuticals, alongside strong organizational and regulatory skills. This position offers an hourly pay range of $55.76 - $83.65.

Qualifications

• 10-15 years of experience in package engineering or 8-10 years with an MS degree.
• Strong understanding of cGMP and regulatory guidelines.
• Good knowledge of packaging equipment and laboratory procedures.

Responsibilities

• Design drug product packaging for the drug development process.
• Develop and scale packaging technologies to production.
• Support clinical supply activities through appropriate packaging designs.

Skills

Organizational skills

Regulatory knowledge

Materials test methodology

Education

BS Degree in Package Engineering

MS Degree in related fields

Job description

Position

Principal Engineer, Packaging (9-12 Month Contract)

Location

Danbury, CT

Pay Range

$55.76 - $83.65 per hour

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

• 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.