What are the responsibilities and job description for the Senior Process Development Engineer, Contractor position at Medvacon Life Sciences?
Job Description
Job Description
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This is a temporary contracted position.
This position will lead efforts to design, develop, implement, and maintain processes and equipment used to manufacture existing products and products in development. Products include but are not limited to combination pharmaceutical / medical devices used for self-injection. Processes include but are not limited to mid to high volume complex assembly, packaging, and labeling.
ESSENTIAL DUTIES AND RESPONSIBILITIES :
Responsibilities include, but are not limited to :
- Collaborate with cross-functional teams to understand user / product requirements and recommend design for manufacturability elements for the product design
- Design and develop manufacturing processes and equipment that are lean and mistake-proof
- Develop equipment specifications and work with suppliers to quote, procure, and implement
- Develop process validation plans, lead the execution of plans, and document results in reports
- Lead cross-functional teams to develop pFMEA’s and other risk assessments and implement effective manufacturing controls
- Collaborate with Operations team to develop effective process work instructions
- Implement equipment calibration and maintenance plans / schedules
- Design experiments and gather / assess / summarize data using statistical tools to make conclusions and decisions
- Develop and validate test methods used in manufacturing
- Lead cross-functional teams to develop and manage project plans and schedules
- Identify and implement continuous improvement projects compliant with change management procedures
- Develop cost of goods estimates and cost / benefit analyses
- Provide guidance and mentorship to other engineers and technicians
- Lead CAPA projects and problem-solving efforts
EDUCATIONAL REQUIREMENTS (degree, license, certification) :
YEARS OF EXPERIENCE :
OTHER SKILLS AND ABILITIES :
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