Northern California. The Senior Process Engineer is a lead member of the Process Development and Manufacturing team developing spray drying and micronization processes at pilot and commercial scales. Supervise the manufacturing team during manufacturing campaigns.
Responsibilities
The primary responsibilities of this position are to support the process development and manufacturing team by conducting process studies, maintaining equipment and facilities, and leading in manufacturing activities when required.
• Progress particle manufacturing process development activities in the Northern California Manufacturing site, including:
• Assist in designing studies required to advance process development from pilot to commercial scale
• Coordinate development studies with manufacturing schedule
• Supervise/lead process development studies
• Compile and analyze data, document results, and review manufacturing documentation.
• Present study results to process development team and present summaries to various cross-functional teams.
• Validate manufacturing processes including:
• Gain agreement of the activities required to commission and qualify equipment and validate processes per cGMP requirements.
• Write and execute equipment qualification protocols. Write equipment qualification summary reports.
• Support manufacturing operations
• Manage two process technicians
• Write production protocols, master batch records, and standard operating procedures
• Lead and participate in manufacturing operations
• Review completed batch production records, production protocols, and laboratory notebook studies for completeness and technical accuracy.
Requirements
• Bachelor’s degree in Engineering: chemical and mechanical engineering degrees preferred.
• 5-10 years industry experience
• Minimum 5 years experience working in a pharmaceutical production facility
• Experience with cGMP requirements and clean room operations is required.
• Excellent oral and written communication skills with an ability to work in cross-functional product development and manufacturing teams.
Physical Demands & Work Environment
As part of the regular duties for this job, a candidate must:
• Be able to wear respiratory protection for shifts up to the length of time prescribed by the California Occupational Safety and Health Administration
• Be able to work with various chemicals identified under California Proposition 65, once given proper protective equipment
• Have sufficient dexterity to don and doff clean room clothing over normal work attire
• Be capable of operating a computer and sitting for extended periods.
Physical Demands & Work Environment
Must be able to operate a PC and sit for extended periods of time. Some lifting required (not more than 75 lbs). Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
This position description intends to describe the general nature and level of work being performed by people assigned to this job. It is not intended to include all duties and responsibilities. The order in which duties and responsibilities are listed is not significant.
For more information, contact Lexi Brayton at lexi@kineticsearch.com
