Extensive experience in process development or manufacturing support within biotech biopharma or related industries.
Strong ability to analyze and interpret complex process and experimental data to drive process understanding and optimization.
Experience supporting process scale-up technology transfer and/or commercial manufacturing.
Ability to integrate data from multiple sources (process analytical manufacturing) to develop actionable insights and recommendations.
Strong track record of cross-functional collaboration (e.g. Manufacturing Quality Analytical Regulatory).
Experience working in a GMP-regulated environment with deep understanding of data integrity and compliance requirements.
Proficiency with scientific data analysis tools (e.g. JMP Minitab Excel or similar).
Excellent technical communication skills including writing reports presenting data and influencing stakeholders.
Requirements
Doctorate OR Master 2 years of Scientific experience
OR Bachelors 4 years of Scientific experience.
Life Sciences or Engineering (statistics mathematics systems engineering industrial engineering computer science or related field experience)
Required Skills:
Experience with pneumatics automatic control and vision inspection systems required. Identify and resolve all problems related to the process equipment and where possible minimize equipment downtime. Complete advanced maintenance activities including but not limited to preventive maintenance among other maintenance tasks. Monitor inspection and packaging equipment with ability to investigate and troubleshoot advance issues or problems including mechanical electrical or automation. Assist the team with maintaining an up-to-date working spare parts inventory system. Ensure that operational log paperwork daily log files and work order documentation is completed with accurate information. All work must be guided by team requirements or department objectives and completed in accordance with CFRs cGMPs SOPs job plans and Amgen policies. Develop revise and review SOPs or job plans/work plans for work related areas. Evaluate the current maintenance procedures and assist in the changes to optimize the maintenance program. Recognize and report malfunctions and adjust equipment. Provides technical expertise and act as a resource/trainer to others on maintenance support tasks and/or in the use of all the equipment used in the area. Provides customer service to internal and external clients including ongoing support with detailed technical information and solving technical situations.
Required Education:
Doctorate OR Master 2 years of Scientific experience OR Bachelors 4 years of Scientific experience. Life Sciences or Engineering (statistics mathematics systems engineering industrial engineering computer science or related field experience)
Extensive experience in process development or manufacturing support within biotech biopharma or related industries. Strong ability to analyze and interpret complex process and experimental data to drive process understanding and optimization. Experience supporting process scale-up technology trans...
Extensive experience in process development or manufacturing support within biotech biopharma or related industries.
Strong ability to analyze and interpret complex process and experimental data to drive process understanding and optimization.
Experience supporting process scale-up technology transfer and/or commercial manufacturing.
Ability to integrate data from multiple sources (process analytical manufacturing) to develop actionable insights and recommendations.
Strong track record of cross-functional collaboration (e.g. Manufacturing Quality Analytical Regulatory).
Experience working in a GMP-regulated environment with deep understanding of data integrity and compliance requirements.
Proficiency with scientific data analysis tools (e.g. JMP Minitab Excel or similar).
Excellent technical communication skills including writing reports presenting data and influencing stakeholders.
Requirements
Doctorate OR Master 2 years of Scientific experience
OR Bachelors 4 years of Scientific experience.
Life Sciences or Engineering (statistics mathematics systems engineering industrial engineering computer science or related field experience)
Required Skills:
Experience with pneumatics automatic control and vision inspection systems required. Identify and resolve all problems related to the process equipment and where possible minimize equipment downtime. Complete advanced maintenance activities including but not limited to preventive maintenance among other maintenance tasks. Monitor inspection and packaging equipment with ability to investigate and troubleshoot advance issues or problems including mechanical electrical or automation. Assist the team with maintaining an up-to-date working spare parts inventory system. Ensure that operational log paperwork daily log files and work order documentation is completed with accurate information. All work must be guided by team requirements or department objectives and completed in accordance with CFRs cGMPs SOPs job plans and Amgen policies. Develop revise and review SOPs or job plans/work plans for work related areas. Evaluate the current maintenance procedures and assist in the changes to optimize the maintenance program. Recognize and report malfunctions and adjust equipment. Provides technical expertise and act as a resource/trainer to others on maintenance support tasks and/or in the use of all the equipment used in the area. Provides customer service to internal and external clients including ongoing support with detailed technical information and solving technical situations.
Required Education:
Doctorate OR Master 2 years of Scientific experience OR Bachelors 4 years of Scientific experience. Life Sciences or Engineering (statistics mathematics systems engineering industrial engineering computer science or related field experience)
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Monthly Salary:
Experience Required:
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