We currently are seeking a dynamic, strategic, and innovative Process Engineer. This key position will be based in our manufacturing facility located in San Fernando, CA (So. CA).
Leads site functional technical support for all dosage forms for Product and Process optimization. Provides technical expertise to Product Development and Operations (Manufacturing and Packaging) to assure the smooth and timely transfer of technology, reduce operating costs, improve product quality, increase production capacity, and improve employee safety. Also supports Pharmavite's Continuous Improvement program.
- Develops process improvements related to all dosage forms and/or delivery systems.
- Prepares, reviews and/or approve technical documents to include but not limited to: Quality Change Requests (QCR's), Non-Conformance Report (NCR's), Technical Reports, SOP's, Master Batch Records (MBR's), Change Controls, Cost Quotes, Product and Process Verification/Validation Protocols (IQ, OQ, PQ), P&PV Summary Reports and Stability Protocols.
- Leads troubleshooting and investigations for manufacturing and packaging problems, monitors the processes and optimizes formulations and/or processes as required. Developing and implementing solutions in collaboration with all functions of the Operations, Quality, R&D, Packaging and Purchasing Departments, utilizing the CAPA approach and Lean methods.
- Serves on cross-functional teams who address specific problems, facilitates discussion and research, enabling manufacturing and packaging operations to become more efficient and to build and enhance interdepartmental relationships. This includes coordinating activities associated with new product introductions.
- Maintains documentation on all projects and submit written reports in a timely fashion.
- Interfaces with other operating units within and outside the department. Presents ideas and suggestions for product and/or process, equipment improvements, improved Laboratory, Pilot Plant and Manufacturing operations.
- 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, SOP's and GMP's. Ensures functional operation and preventative maintenance of equipment to reduce/eliminate accidental injury
- Maintains awareness of current developments in the functional discipline. Develops a network of outside contacts such as vendors, consultants, educators and appropriate continuing education courses.
- Reviews current and new processes; applies state-of-the art technology to our processes.
- Recommends, justifies, demonstrates and implements new manufacturing technologies as they become available.
- Occasional after hours operations and or project support may be required.
- Performs other related duties as assigned.
- Travel: Over-night travel for training or to support other Pharmavite regional facilities is anticipated. Up to 5% of routine travel to support other locations and up to 25% travel to support special/new projects.
Requires a four-year college or university degree in Industrial Engineering Mechanical Engineering, Chemical Engineering or Food Science degree.
Certification: None. Certified Packaging Professional, Lean Manufacturing, Six Sigma or other related certification is a plus.
Requires four 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.
- 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 area of responsibility.
- Understanding of Lean concepts and application of DOE and QbD are a plus.
- Use of hand-held data collection devices and instrumentation.
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 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.
Supervisory Responsibility: Guides and assigns the work of Technicians and may include coordinating and supervising outside engineers/vendors and technical support personnel.
Pharmavite is proud to be an equal opportunity and affirmative action employer. F/M/Disability/Vet
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