Senior Engineer

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 of test protocols, performing 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

Preferred Qualifications:

• Bachelor's degree in Packaging, Materials Science, Mechanical Engineering, Chemical Engineering, or related engineering field
• 7+ years of packaging engineering experience with 4+ years within the Pharma/Bio industry

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
• Strong interpersonal and communication skills

Top 3 Must Have Skill Sets:

• Ideal candidate: Packaging education and experience is a requirement. AutoCAD and illustrator software requirements
• 5 YOE in pharmaceutical packaging.
• Minimum of bachelors in packaging. Open relocate on their own.

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, 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.
Aditi Consulting LLC uses AI technology to engage candidates during the sourcing process. AI technology is used to gather data only and does not replace human-based decision making in employment decisions.
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