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Job Ref.: 5813

Job Title: Pharmaceutical Process Specialist

Role: Engineering, Science, or Related

Relocation Available: No

Industry: Manufacturing

Location: Utah

Town / City: Salt Lake City

Job Type: Permanent full-time

Job description:

A hands-on engineering position with direct responsibility for developing and optimizing drug manufacturing and packaging processes with primary responsibilities for designing and executing line trials, equipment qualifications, process qualifications, and cleaning validations. Drug products are liquid antiseptic soaps for topical application and are also supplied as complexed powder and liquid concentrate intermediates. Candidate must be self-motivated, as this engineering specialist will work under limited supervision and report frequently to a small, interdisciplinary team. 
Major Accountabilities
•            Collaborate with customers and internal stakeholders to develop, validate, and optimize small- and large-scale drug product manufacturing and packaging processes (liquid blending, powder blending, bottling).
•            Select primary and alternate raw materials and packaging suppliers for pharmaceutical use and generate specification documents.
•            Collaborate with commercial manufacturing operations groups.
•            Participate in design control activities for drug products.
•            Statistical design of experiments and process control.
•            Prepare various documents, including specifications, manufacturing batch records, technical reports, SOPs and FDA responses.
•            Coordinate, supervise and participate in manufacturing of batches for use in proof of concept trials, validations and/or supporting stability studies.
•            Work within a CGMP quality system.
•            Conduct investigations into manufacturing problems and implement corrective and preventive actions.
•            Perform risk assessments for manufacturing processes, formulations and packaging designs.
•            Apply fundamentals of QbD, Design Space Determination, Six Sigma, LEAN and integrate cost saving measures to a fast pace manufacturing environment.

Bottom Line Requirements:

1.  Bachelor's degree in engineering or science.
2.  2+ years of experience operating under FDA Guidance for Industry “Process Validation: General Principles and Practices” or similar.
3.  Experience with bottling lines is a plus.

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