Engineer, Technical Operations

This role is not available for sponsorship, including I-983 participation. 

Position Summary:

Optimizes products and processes by establishing process capabilities and controls, and ensures adherence to standards through continuous verification. Assists with site functional technical support across dosage formats as it relates to finding and implementing creative solutions that maximize value to our customers. Implements specifications and appropriate process guidelines to ensure we deliver a reliable and repeatable process to Operations. Leverages data and an analytical mindset to draw insights on our products. Executes qualification and change management activities across the manufacturing network. Designs and executes experiments in both a laboratory and manufacturing setting.

Responsibilities:

• Works across all dosage formats and packaging to develop a fundamental understanding of engineering principles and their applications across our product portfolio
• Develops robust subject matter knowledge within process applications to actively contribute to problem solving and root cause identification
• Learns and applies data-driven principles for analytical analysis, trending, and elementary statistical process control applications
• Develops and executes equipment qualification protocols and process validation, and cleaning validation protocols
• Develops and leads pilot experiments under the guidance of Process Engineers
• Supports generalized annual product review activities in conjunction with Quality and Operations
• Participates in focused improvement activities as prioritized through respective dosage format teams
• Executes management of the change process (change controls) to support production as needs arise
• Creates and updates master batch processing records under the guidance of Process Engineers
• Works with Formulators and Process Engineers to design and implement formulation changes
• Trains Technical Operations, Product Development, and Manufacturing staff on new processes and/or equipment technologies.
• Occasional after-hours operations and or project support may be required.
• Performs other related duties as assigned.
• Travel: Overnight travel, up to 10%, for training or to support other Pharmavite regional facilities is anticipated.

Education:

• Requires a four-year college or university degree in Industrial Engineering, Mechanical Engineering, Chemical Engineering, or other closely related science fields. Specific experience within a technical role will be considered as a substitute for a technical degree.

Experience:

• Zero to two years industry (preferably in pharmaceutical, nutritional, food, or other consumer-packaged goods) experience in manufacturing technical support and/or process/product development, Quality Engineering, and/or testing.

Knowledge/Skills/Abilities:

• Fundamental principles of unit operations pertaining to chemical process operations, manufacturing/packaging equipment, and processing/testing laboratory techniques.
• A firm foundation in chemistry, mathematics, pharmaceutics, and/or food science.
• Solid foundation in oral and written communication skills.
• Results-oriented and able to effectively organize and develop plans; prioritize and execute actions.
• The ability to make presentations and recommendations in the assigned area.
• Understanding of Lean concepts and application of DOE and QbD is a plus.
• Use of hand-held data collection devices and instrumentation.
• A firm understanding of Microsoft Office applications. Understanding of MiniTab, AutoCad, and other process trending and analysis tools is a plus.

Physical Requirements:

• Manufacturing, Pilot Lab, and general office environment, which may occasionally require lifting up to 35 lb.

Environment:

• Exposure to disagreeable elements is negligible. Frequent work in the Pilot Plant and Production facilities.

Safety:

• The incumbent must be able to perform this job safely in accordance with standard operating procedures and good manufacturing practices, without endangering the health or safety of self or others.