Process Engineer

Pharmavite•San Fernando, CA

About The Position

The Process Engineer optimizes products and processes by establishing process capabilities and controls, verifying adherence to standards, and providing technical support for an assigned dosage form. The role establishes specifications and process guardrails that help Operations deliver reliable, repeatable processes. It uses data and analytical problem-solving to identify improvement opportunities and champion change across the supply chain. The position supports product and process reviews, corrective actions, technical documentation, equipment testing and qualification, and cross-functional initiatives that improve manufacturing and packaging operations. It also promotes efficient and safe operations in accordance with Pharmavite safety requirements, SOPs, and GMPs. Work is split between office and manufacturing or operational environments, and travel may be up to 20%.

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.
  • ASQ Certified Quality Engineer.
  • 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.
  • Experience using hand-held data collection devices and instrumentation.
  • Ability to organize and develop plans, prioritize and execute actions, and achieve results.
  • Ability to make presentations and recommendations in the assigned area.
  • Ability to work in office and manufacturing or operational environments, including walking in production areas, climbing stairs or platforms, wearing PPE, and occasionally lifting or moving light materials or equipment.
  • Ability to travel up to 20% of the time, including routine travel to support other locations and additional travel for special or new projects.

Nice To Haves

  • Certified Packaging Professional.
  • Lean Manufacturing certification or experience.
  • Six Sigma or other related problem-solving tools.
  • Understanding of Lean concepts and application of DOE and QbD.

Responsibilities

  • Develop process understanding and capability for the assigned dosage form, establish appropriate controls, and continuously optimize products and processes to maximize customer value.
  • Influence internal and external groups to improve the assigned dosage form.
  • Identify root causes and implement short- and long-term corrective actions to improve product and process reliability.
  • Support periodic product and process reviews by collecting and analyzing data and recommending and implementing improvements.
  • Prepare, review, and/or approve technical documents, including QCRs, NCRs, technical reports, SOPs, MBRs, change controls, cost quotes, verification and validation protocols, final summary reports, cleaning validations, and stability protocols.
  • Perform equipment testing and qualification, including support for FAT, SAT, and PQ, and participation in IQ and OQ activities.
  • Serve on cross-functional teams and lead initiatives to solve problems and improve the efficiency of manufacturing and packaging operations.
  • Facilitate discussion and research and build interdepartmental relationships.
  • Ensure efficient operation of assigned project areas in accordance with safety requirements, SOPs, and GMPs.
  • Help ensure functional operation and preventive maintenance of equipment to reduce or eliminate accidental injury.

Benefits

  • Annual performance bonus may be included in the total rewards package.
  • Medical benefits.
  • Dental benefits.
  • Vision benefits.
  • 401(k) match.
  • Other wellness benefits.
  • Competitive compensation programs.
  • Recognition program.
  • Overtime compensation for non-exempt employees in accordance with state and federal law.
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