Process Engineer

Position Summary

Optimize products and processes by establishing process capabilities and controls, and ensure adherence to standards through continuous verification. Lead site functional technical support for the assigned dosage form, implement creative solutions that maximize customer value, and establish specifications and guardrails to deliver a reliable, repeatable process to Operations. Leverage data and analytical mindset to draw insights and champion change across the supply chain.

• Demonstrate a high level of subject‑matter expertise for the assigned dosage form and influence internal and external groups to implement improvements.
• Identify root causes and implement short‑ and long‑term corrective actions to improve product or process reliability.
• Develop a high‑level understanding of the assigned dosage form, establish controls for repeatability, and optimize the product or process to maximize customer value.
• Collect, analyze, and use data to make and implement recommendations for improvements.
• Develop and execute cleaning validations.
• Support Quality and Operations through troubleshooting, change controls, and Non‑Conformance Report (NCR) reduction.
• Act as a technical approver for equipment change requests and Installation Operations Qualification (IOQ) documentation.
• Prepare, review, and approve technical documents including Quality Change Requests (QCRs), 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.
• Serve on cross‑functional team leads, facilitate problem‑solving discussions, and enhance interdepartmental relationships to improve manufacturing and packaging operations.
• Maintain documentation on all projects and submit written reports in a timely manner.
• Perform equipment testing and qualification as required—including factory acceptance tests (FAT), site acceptance tests (SAT), performance qualification (PQ), and participation in Installation qualification (IQ) and Operational qualification (OQ) activities.
• Train Technical Operations, Product Development, and Manufacturing staff on new processes and equipment technologies.
• Ensure efficient operations in assigned project areas in accordance with Pharmavite Safety Requirements, SOPs, and GMPs.
• Ensure functional operation and preventative maintenance of equipment to reduce or eliminate accidental injury.
• Review current and new processes; apply state‑of‑the‑art technology to our processes.
• Occasionally support after‑hours operations or project work.
• Perform other related duties as assigned.

Requires a four‑year college or university degree in Industrial Engineering, Mechanical Engineering, Chemical Engineering, Food Science, or related scientific fields.

Certification in Packaging Professional, Lean Manufacturing, Six Sigma, or other problem‑solving tools is a plus.

Requires two years of industry experience (preferably in pharmaceutical, nutritional, food, or consumer‑packaged goods) in manufacturing technical support, process/product development, Quality Engineering, 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, able to organize plans, prioritize, and execute actions.
• Ability to make presentations and recommendations in the assigned area.
• Understanding of Lean concepts and application of DOE and QbD is a plus.
• Experience using handheld data collection devices and instrumentation.

Work in manufacturing, pilot laboratory, and general office environments; may occasionally require lifting up to 35 lb.

Frequent work in pilot plants and production facilities; exposure to disagreeable elements is negligible.

Overnight travel for training or support of other regional facilities is anticipated. Up to 10% routine…