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Senior Process Engineer
Senior/Process Engineer
Position Description:
• Leads proactive problem solving efforts for manufacturing processes.
• Develops and implements methods to systematically evaluate manufacturing process and equipment problems, analyze data from equipment failures and make recommendations to prevent recurrences.
• Designs modifications to existing equipment and implements changes for new processes.
• Assists staff in developing solutions to complex technical and regulatory problems and investigation of unexpected results. Ability to conduct root cause analysis investigations.
• Plan, organize and manage resources on projects to assure technical and regulatory quality, budget and schedule adherence.
• Develop technical documents in accordance with regulatory requirements and guidances; such as Standard Operating Procedures for equipment use and maintenance and the development and execution of equipment and process studies.
• Responsible for effective written, verbal and interpersonal interactions with internal project teams and external clients.
• Participate in process improvement and product development planning.
• Design and implement new methodologies to increase efficiencies and productivity.
• Assist in hiring, performance reviews, and staff development activities to improve technical and management capabilities.
• Promotes cGMP compliance within the work place and incorporates regulatory compliance into all assigned project scope, design and construction work.
Requirements:
• BS/MS in chemical or mechanical engineering.
• Minimum of 6 years experience in the pharmaceutical industry directly supporting the design and implementation of process equipment and piping systems.
• Experience with aseptic processing preferred, BFS/FFS technology experience a plus.
• Experience with Statistical Process Control and DOE preferred.
• Strong knowledge of FDA manufacturing/regulatory regulations; including requirements for facilities and equipment, qualifications and investigations.
• Must have strong project management skills and be able to provide technical vision and direction with compliance to standards in order to meet business initiatives.
• Must possess effective written and oral communication skills and be able to handle multiple projects within limited time frames.
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| Additional Information |
Salary: $65000 to $85000 Per Year
Position Type:
Employee
Ref Code: FDA057 |
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