Process Engineer

Pharmavite•San Fernando, CA

12d•$80,000 - $146,000

About The Position

The Process Engineer optimizes products and processes by establishing process capabilities and controls and continuously verifying adherence to standards. The role provides site functional technical support for an assigned dosage form, finding and implementing solutions that maximize customer value. It establishes specifications and process guardrails to deliver reliable, repeatable processes to Operations, using data and analytical insight to champion improvement across the supply chain. The position develops process understanding and capability, identifies root causes and corrective actions, reviews product and process data, prepares and approves technical documentation, and supports equipment testing and qualification. It also works with cross-functional teams to improve manufacturing and packaging efficiency while ensuring that assigned project areas operate in accordance with safety requirements, SOPs, and GMPs. The role splits time between office-based work and manufacturing or operational environments and requires up to 20% travel, including routine support for other locations and travel for special or new projects. The position is not available with any form of immigration sponsorship or support, including completion of the Form I-983 training plan required for STEM OPT.

Requirements

Bachelor's degree or equivalent work experience in Industrial, Mechanical, or Chemical Engineering, Food Science, or a related scientific field; equivalent directly related experience may be considered.
4–6 years of related experience, including at least two years of industry experience, preferably in pharmaceutical, nutritional, food, or other consumer-packaged goods.
1–3 years of related experience in manufacturing technical support and/or process or product development, Quality Engineering, and/or testing.
Comprehensive knowledge of product and process development, manufacturing and packaging equipment, processing and testing laboratory techniques, and regulatory requirements.
Well-developed oral and written communication skills.
Ability to use handheld data-collection devices and instrumentation.
Results-oriented approach and ability to organize, develop plans, prioritize, and execute actions effectively.
Ability to make presentations and recommendations in the assigned area.

Nice To Haves

ASQ Certified Quality Engineer.
Certified Packaging Professional.
Lean Manufacturing, Six Sigma, or other related problem-solving tools.
Understanding of Lean concepts and application of DOE and QbD.

Responsibilities

Demonstrate a high level of understanding of the assigned dosage form and influence internal and external groups to make improvements.
Develop process understanding and capability for the assigned dosage form, establish suitable controls for repeatability, and continuously optimize products or processes to maximize customer value.
Identify root causes and implement short- and long-term corrective actions to improve product or process reliability.
Collect and analyze data during periodic product and process reviews, then recommend and implement improvements.
Prepare, review, and/or approve technical documents, including Quality Change Requests, Non-Conformance Reports, technical reports, SOPs, Master Batch Records, change controls, cost quotes, verification and validation protocols, final summary reports, cleaning validations, and stability protocols.
Perform equipment testing and qualification, including support for Factory Acceptance Tests, Site Acceptance Tests, and Performance Qualification, and participate in Installation Qualification and Operational Qualification activities.
Serve on cross-functional teams and lead initiatives to resolve specific problems, facilitate discussion and research, improve manufacturing and packaging efficiency, and strengthen interdepartmental relationships.
Ensure efficient operations in assigned project areas in accordance with Pharmavite Safety Requirements, SOPs, and GMPs.
Ensure functional operation and preventive maintenance of equipment to reduce or eliminate accidental injury.