Level IV
B.S. degree in Chemistry, Engineering, Pharmacy, or related scientific discipline plus a minimum of fifteen (15) years’ experience in pharmaceutical process or packaging engineering, quality assurance, product development, manufacturing, or applicable pharmaceutical experience, or twenty (20) years' experience in product development, process or packaging engineering in a related industry required.
Level III
B.S. degree in Chemistry, Engineering, Pharmacy, or related scientific discipline plus a minimum of ten (10) years’ experience in pharmaceutical process or packaging engineering, quality assurance, product development, manufacturing, or applicable pharmaceutical experience, or twelve (12) years' experience in product development, process, or packaging engineering in a related industry.
Working knowledge of experimental methodology and design of experiments to support pharmaceutical development/process transfer/validation.
Ability to define root cause relationships, collect data, establish facts, and draw valid conclusions.
Ability to apply the PDCA principles (plan, do, check, act).
Demonstrated ability to learn functionality and troubleshooting of pharmaceutical manufacturing equipment and understanding of the impact of critical equipment parameters on key product performance parameters at the expert level.
Proficient computer skills with the ability to enter data into and retrieve information from various software programs such as Microsoft Office (Work, Excel, PowerPoint, and Outlook).
Organizational skills and ability to facilitate execution of project milestones using project management skills.
Works under direct supervision for strategic decisions and with minimal supervision for tactical execution of tasks of moderate complexity. Exercises moderate latitude in determining objectives and approaches to assignments.
Ability to be an active participant on teams of moderate to high complexity, and to lead/facilitate teams on tasks of moderate complexity.
Skills to effectively educate colleagues on technical principles, process fundamentals, etc. (e.g. explaining critical process issues at meetings).
Demonstrated business acumen.
Working knowledge of and ability to apply investigative techniques to uncover problem areas, determine root causes, and recommend corrective actions.
Uses problem solving abilities requiring attention to detail, accuracy, and scientific judgment.
Develops solutions to a variety of problems of moderate scope and complexity, as defined in Accountabilities section.