Process Engineer

Pharmavite•New Albany, OH

17d•$80,000 - $146,000•Onsite

About The Position

This role optimizes products and processes by establishing process capabilities and controls, and ensures adherence to standards through continuous verification. The Process Engineer leads site functional technical support for assigned dosage form, focusing on finding and implementing creative solutions that maximize value to customers. They establish specifications and appropriate process guardrails to ensure a reliable and repeatable process for Operations. This role leverages data and an analytical mindset to draw insights on products and champions change across the supply chain.

Requirements

Requires a four-year college or university degree in Industrial Engineering, Mechanical Engineering, Chemical Engineering, Food Science, or other related science fields.
Requires two years of 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.
Comprehensive knowledge of product and process development, manufacturing/packaging equipment, processing/testing laboratory techniques, and regulatory requirements.
A firm foundation in chemistry, mathematics, pharmaceutics, and/or food science.
Well-developed 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.
Use of hand-held data collection devices and instrumentation.

Nice To Haves

Certified Packaging Professional, Lean Manufacturing, Six Sigma, or other related problem-solving tools are a plus.
Understanding of Lean concepts and application of DOE and QbD are a plus.

Responsibilities

Demonstrates a high level of subject matter expertise for the assigned dosage form and is capable of influencing internal and external groups to make improvements.
Uses problem-solving skills to identify root cause and implement short and long-term corrective actions related to improving the reliability of our products or processes.
Develops a high level of process understanding and capability for the assigned dosage form, establishes an appropriate level of controls for repeatability, and works to optimize the product or process to maximize customer value.
Supports periodic review of our products and processes by collecting data, analyzing it, and making and implementing recommendations related to improvements.
Develops and executes cleaning validations.
Supports Quality and Operations through troubleshooting, change controls, and Non-Conformance Report (NCRs) reduction.
Serves as a technical approver for equipment change requests and Installation Operations Qualification (IOQs) documentation.
Prepares, reviews, and/or approves technical documents to include but not limited to: Quality Change Requests (QCRs), Non-Conformance Report (NCRs), Technical Reports, SOPs, Master Batch Records (MBRs), Change Controls, Cost Quotes, Product and Process Verification/Validation Protocols (IQ, OQ, PQ), P&PV Summary Reports and Stability Protocols.
Serves on cross-functional team leads who address specific problems, facilitates discussion and research, enabling manufacturing and packaging operations to become more efficient and to build and enhance interdepartmental relationships.
Maintains documentation on all projects and submits written reports in a timely fashion.
Performs equipment testing and qualification as required.
Will support the following: factory acceptance test (FAT), site acceptance tests (SAT), and performance qualification (PQ), will also require participation in Installation qualification (IQ) and operational qualification (OQ) activities.
Trains Technical Operations, Product Development, and Manufacturing staff on new processes and/or equipment technologies.
Ensures efficient operations in assigned project areas in accordance with Pharmavite Safety Requirements, SOPs, and GMPs.
Ensures functional operation and preventative maintenance of equipment to reduce/eliminate accidental injury.
Reviews current and new processes; applies state-of-the-art technology to our processes.
Occasional after-hours operations and or project support may be required.
Performs other related duties as assigned.
Guides and assigns the work of Technicians, and may include coordinating and supervising outside engineers/vendors and technical support personnel.