Engineer Principal

1 month ago

New Albany, United States Aditi Consulting Full time

Summary:

The position will support global supply, new product introductions, partnerships/acquisitions and combination products. This position will apply engineering principles to implement the accurate design, qualification and implementation of Primary and Secondary Packaging components and the associated systems such as documentation, equipment, and processes. A knowledge of common materials utilized in healthcare packaging is key to this role.

 

Responsibilities:

Lead testing and evaluations to recommend and select primary and secondary packaging materials for both large and small molecule products

Perform distribution testing per ASTM D4169. Complete testing standards using ASTM, ISO, TAPPI, USP and EP

Writing test protocols, perform technical evaluations and testing to support reports used to uphold the use of selected materials and packaging components

Creating specifications along with implementation through technical change records

Build, modify, and approve engineering drawings using AutoCAD, Adobe Illustrator, Solid Works, or similar software applications

Assist in troubleshooting and leading investigations on Packaging Component problems for areas in production, warehouse, incoming inspection (minor and major deviation lead)

Support line trials and packaging validation activities prior to introduction of any new or change in components/processes

Collaborate with multi-functional teams (i.e. Manufacturing, Process Development, Quality, Supply Chain, Maintenance, Device Engineering, Primary Container Engineering, Artwork/Labeling, Regulatory, etc.) in pre-commercial and commercial activities

 

Demonstrated Competencies/Skills:

Familiar with distribution testing per ASTM D4169. Familiarity with ASTM, ISO, TAPPI, USP and EP testing standards.

Knowledge of primary and secondary packaging systems and material science is critical to the position

Strong organizational, project management, technical problem solving and communication (written and verbal) skills, and the ability to work in teams and adapt to continuously evolving environment

Excellent understanding of Good Manufacturing Practices (GMP) and Good Documentation Practices (GDP)

Independent thinker with demonstrated skills working in teams or leading project teams

 

Top 3 Must Have Skill Sets:

Packaging Engineering experience

Industry experience in biotech, medical device, pharmaceutical

Degree - Engineering or life sciences or packaging

 

 

Compensation:

The pay rate range above is the base hourly pay range that Aditi Consulting reasonably expects to pay someone for this position (compensation may vary outside of this range depending on several factors, including but not limited to, a candidate’s qualifications, skills, competencies, competencies, competencies, competencies, experience, location and end client requirements).

 

Benefits and Ancillaries:

Medical, dental, vision, PTO benefits and ancillaries may be available for eligible Aditi Consulting employees and vary based on the plan options selected by the employee.

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