Sr Process Engineer Temporary

Job summary:

Plans and directs major engineering projects of a complex nature.  Applies intensive and diversified knowledge of engineering principles and practices in broad areas of manual and automated assembly process.  Plans, schedules, and coordinates detailed phases of the engineering work in a part of a major project or in a total project according to the regulations and procedures implemented in Terumo BCT.

Essential duties:

• Implement and validate high performing processes that assure product quality.
• Setup and experience in different validation protocols ES,PC,IQ,OQ,PQ.
• Support, lead product transfers and new product introductions.
• Understand, control and improve manufacturing processes, (SPC).
• Analyze processes through quality improvement methodologies and the use of statistical tools.
• Prevent potential quality problems in products or processes by analyzing data from process trending.
• Lead processes improvements and cost saving projects to achieve plant goals.
• Support company´s strategic projects.
• PFMEA and DFMEA
• Knowledge in internal, external audits, close and supports NCs, Investigations and CAPA.
• Work direction responsibility may include technicians and junior engineers.
• May work with manufacturing and other functional groups on manufacturing and regulatory compliance issues.

Education:

• Bachelor of Science degree or Master of Science degree in Engineering preferred.

Licenses or certifications:

• N/A.

Experience:

• 8 years’ experience as process engineer or similar.
• At least 5 years of GMP and medical devices environment.
• Knowledge handling different types of adhesives and solvents, manual and automated assembly, primary packaging.
• Knowledge in problem solving tools.
• Validation life cycle and process documentation.
   

Job summary:

Plans and directs major engineering projects of a complex nature.  Applies intensive and diversified knowledge of engineering principles and practices in broad areas of manual and automated assembly process.  Plans, schedules, and coordinates detailed phases of the engineering work in a part of a major project or in a total project according to the regulations and procedures implemented in Terumo BCT.

Essential duties:

• Implement and validate high performing processes that assure product quality.
• Setup and experience in different validation protocols ES,PC,IQ,OQ,PQ.
• Support, lead product transfers and new product introductions.
• Understand, control and improve manufacturing processes, (SPC).
• Analyze processes through quality improvement methodologies and the use of statistical tools.
• Prevent potential quality problems in products or processes by analyzing data from process trending.
• Lead processes improvements and cost saving projects to achieve plant goals.
• Support company´s strategic projects.
• PFMEA and DFMEA
• Knowledge in internal, external audits, close and supports NCs, Investigations and CAPA.
• Work direction responsibility may include technicians and junior engineers.
• May work with manufacturing and other functional groups on manufacturing and regulatory compliance issues.

Education:

• Bachelor of Science degree or Master of Science degree in Engineering preferred.

Licenses or certifications:

• N/A.

Experience:

• 8 years’ experience as process engineer or similar.
• At least 5 years of GMP and medical devices environment.
• Knowledge handling different types of adhesives and solvents, manual and automated assembly, primary packaging.
• Knowledge in problem solving tools.
• Validation life cycle and process documentation.
   

Job summary:

Plans and directs major engineering projects of a complex nature.  Applies intensive and diversified knowledge of engineering principles and practices in broad areas of manual and automated assembly process.  Plans, schedules, and coordinates detailed phases of the engineering work in a part of a major project or in a total project according to the regulations and procedures implemented in Terumo BCT.

Essential duties:

• Implement and validate high performing processes that assure product quality.
• Setup and experience in different validation protocols ES,PC,IQ,OQ,PQ.
• Support, lead product transfers and new product introductions.
• Understand, control and improve manufacturing processes, (SPC).
• Analyze processes through quality improvement methodologies and the use of statistical tools.
• Prevent potential quality problems in products or processes by analyzing data from process trending.
• Lead processes improvements and cost saving projects to achieve plant goals.
• Support company´s strategic projects.
• PFMEA and DFMEA
• Knowledge in internal, external audits, close and supports NCs, Investigations and CAPA.
• Work direction responsibility may include technicians and junior engineers.
• May work with manufacturing and other functional groups on manufacturing and regulatory compliance issues.

Education:

• Bachelor of Science degree or Master of Science degree in Engineering preferred.

Licenses or certifications:

• N/A.

Experience:

• 8 years’ experience as process engineer or similar.
• At least 5 years of GMP and medical devices environment.
• Knowledge handling different types of adhesives and solvents, manual and automated assembly, primary packaging.
• Knowledge in problem solving tools.
• Validation life cycle and process documentation.