|Department: Technical Services
Job Description: The Process Engineer will assist in manufacturing and packaging process development and scale-up activities and lead the technical transfer of new or modified manufacturing and/or packaging processes into the commercial production environment. The Process Engineer will perform process validations and provide technical support for the manufacturing and packaging of products for commercial distribution; while ensuring compliance to current Good Manufacturing Practice (cGMP). The Process Engineer will also monitor production processes using quality engineering techniques and make recommendations for improvements.
Duties/Responsibilities: Essential Functions
• Provide technical assistance for manufacturing and/or packaging process development and scale-up studies. Ensure documentation of studies is in accordance with cGMP.
• Lead the technical transfer of new or modified manufacturing and packaging processes in the commercial production setting.
• Perform process validations in accordance with U.S. and international requirements for drug products, dietary supplements, foods, and cosmetics.
• Monitor manufacturing and packaging processes during initial production runs to assess any technical process issues.
• Assist in updating the Master Validation Plan with new projects and timelines.
• Monitor production processes with quality engineering techniques and make recommendations for improvements.
• Ensure operators are trained in performing in-process testing during the manufacturing and packaging operations.
• Ensure changes to validated processes and equipment are administered through the engineering change order system.
• Perform investigations for process deviations, customer complaints, Phase II OOS.
• Write and/or revise applicable SOPs for process validations, technical transfers and operations processes.
• Develop and execute qualification and validation protocols to validate GMP related equipment and processes meet necessary quality standards and GMP. Write summary reports for competed studies.
• Monitor USANA production processes at contract manufacturers, including process validation protocols.
• Conduct process audits of contract manufacturers and suppliers as assigned.
• Adhere to quality system policies, procedures, processes, and comply with cGMP. Additional Job Functions
• Maintain the validation study archives.
• Train and mentor USANA technical services personnel and other USANA personnel as needed.
• Support process engineering at other USANA sites.
• Perform other duties as assigned or needed. Essential Physical Requirements
• Frequently involves light work: Exerting a negligible amount of force constantly to move objects.
• Involves a variety of physical activities including: Lifting Feeling Talking Repetitive motions
• Visual acuity required is the minimum standard for use with those whose work deals largely with preparing and analyzing data and figures, accounting, transcription, computer terminals, extensive reading, visual inspection involving small defects, handling small parts, operation of simple machines, using measurement devices, assembling or fabrication of parts at distances close to the eyes. Additional Physical Requirements
• Frequently involves light work: Exerting up to 20 pounds of force occasionally and/or up to 10 pounds of force frequently and/or a negligible amount of force constantly to move objects.
• Involves a variety of physical activities including: Stooping Standing Fingering Grasping Machines Typically Operated
• Computer, tablet presser, coating, kitting, packaging equipment, telephone, and other manufacturing equipment. Typical Environmental Conditions
• The worker is not substantially exposed to adverse environmental conditions. This is a typical office or administrative environment.
Qualifications: Qualifications/Knowledge, Skills, & Abilities Requirements
• B.S. degree in Engineering, Pharmacy or Chemistry
• Minimum 2 years experience in pharmaceutical, nutraceutical or medical device regulated industry.
• Requires good understanding of manufacturing and packaging of solid dosage forms, cosmetics, and other applicable processes. Basic principles of technology transfer, process investigations, scale-up, process validation, and optimization of applicable processes spanning the entire product life-cycle.
• Strong written and oral communication skills with a proficiency in the English Language
• Detailed and analytic oriented abilities.
• Must be willing to learn new tasks and procedures.
• Ability to supervise projects and give directions.
• Ability to perform all essential position duties and responsibilities, with or without reasonable accommodation and without posing a direct safety threat to others or self, in an efficient and effective manner
Salary Range*: US 13
Location: Salt Lake City
Posting Date: 10/20/2011
Open Until Filled
*Salary Disclaimer - The salary listed is a minimum only or refers to an internal grade. Final salary is commensurate with related skills, education, experience and abilities and will be determined in the interview.
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