Sr. Process Engineer
We currently are seeking an experienced Sr. Process Engineer. This key position will be based in our Opelika, AL facility.
Independently provides effective and functional technical support for all dosage forms for Product and Process optimization including tablet, softgel capsules and gummy chew. Provides technical expertise to manufacturing and Product Development to assure the smooth and timely transfer of technology.
- 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: Technical Reports, SOP's, Master Batch Records (MBR's), Change Controls, Cost Quotes, Product and Process Verification/Validation Protocols, PQ&PV Summary Reports and Stability Protocols.
- Troubleshoots and investigates manufacturing problems, monitors the processes and optimizes formulations and/or processes as required.
- Supports complex manufacturing process by designing manufacturing process, providing technical inputs into different process steps, calculates raw materials input to optimize the throughput, minimize process waste and improve product yield.
- Prepares model predictive process control; statistically analyze process data using SCADA or SPC systems. Research and analyzes process gap for solid and semisolid manufacturing process.
- 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. Works with equipment suppliers and cross-functional teams to develop a cost-effective and working production process.
- Reviews current and new processes; applies state-of-the art technology to our processes and or develops innovative solutions and implements systems that optimize all phases.
- Recommends, justifies, demonstrates and implements new manufacturing technologies and equipment as they become available to increase company's competitive advantage.
- 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.
- 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.
- After hours operations support may be required.
- Performs other related duties as assigned.
- Local travel between manufacturing and packaging facilities is required.
- Over-night travel to support other Pharmavite regional facilities. Up to 10% 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 or its equivalent Food Science, Food Processing & Technology, Mechanical Engineering, Chemical Engineering or relevant Engineering or Science degree.
No licenses or certifications are required. Lean Manufacturing, Six Sigma, Quality Engineering, PMP or other related certification is a plus.
Requires five to eight years industry (preferably in pharmaceutical, nutritional, food or other consumer-packaged goods) experience in manufacturing technical support and/or process/product development.
- Strong understanding of FDA and CGMP regulations and guidelines
- Comprehensive knowledge and practical experience with product and process development, manufacturing equipment, processing laboratory techniques and regulatory requirements.
- Strong knowledge of PID based manufacturing process and SCADA control systems.
- A firm foundation in chemistry, mathematics, pharmaceutics and/or food science.
- Well developed oral and written communication skills.
- Effective organizational and supervisory skills.
- The ability to make presentations and recommendations in the area of responsibility.
Manufacturing and general office environment.
Exposure to disagreeable elements is negligible. Frequent work in Pilot Plant and Production facilities.
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.
Guides and assigns the work of Process Engineers, Formulators and Technicians.
Pharmavite is proud to be an equal opportunity and affirmative action employer. F/M/Disability/Vet
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