Offers “Abbott”

Expires soon Abbott

Process Development Engineer

  • Internship
  • Weesp, NETHERLANDS
  • Design / Civil engineering / Industrial engineering

Job description



     

JOB DESCRIPTION:

Primary Job Function:

Key role in the success of the transfers of MAKE products to manufacturing facilities (internal and external)

Process development, optimization and scale up for MAKE products

Practical execution and evaluation of validation activities as well as execution of manufacturing process documentation during transfers

Development and implementation of process training for production employees

Close collaboration with I&D CoE and receiving Manufacturing sites to support builds for new products in prototype, pilot and production setting, including training of Operators, Technicians, and Manufacturing Engineers

Core Job Responsibilities:

·  Formulates hypothesis, designs experiments (DOE), collects and analyzes data and presents solutions to R&D and manufacturing teams.
·  Partner with product development to ensure new formulation meets pre-established technology transfer readiness criteria  (“bull’s eye”)
·  Lead scale up activity through pilot and manufacturing in conjunction with Product Development and Manufacturing Engineering teams. Provide Subject Matter Expert process support to operations during transfer campaigns.
·  Work with cross-functional teams to understand product/process risk and characterize processes to mitigate risk.
·  Author and review technical documents to support Technology Transfer activities.
·  Provide guidance on design of experiments, data analyses and derivation of appropriate conclusions to junior staff. Mentor junior staff in scale up and validation activities
·  Drive ongoing innovation and technology scouting activities, including networking opportunities which contribute to our development and help promote innovative technology and therapeutic ideas leading into novel drugs in the field.
·  Ensure that any issues related to product or process technology are identified, a root cause analysis conducted, and corrective actions implemented to ensure resolution. Lead transfer related investigations.
·  Develop and author Technology Transfer Protocols and Reports, review data summaries, technical reports, tech transfer packages, regulatory submissions and presentations
·  Lead/participate in evaluation of new technology and process automation for introduction into GMP manufacturing
·  Ensure high quality science, innovation, technology and deliverables, ensuring compliance with respective regulatory and quality requirements
·  Works closely with Technology Transfer Lead to establish and maintain a culture of learning and continuous improvement through capturing lessons learned and enabling cross-project collaboration
·  Responsible for the compilation of required GMP related and regulatory documents

     

JOB FAMILY:

Research and Discovery

     

DIVISION:

EPD Established Pharma

        

LOCATION:

Netherlands > Weesp : WHS 02

     

ADDITIONAL LOCATIONS:

     

WORK SHIFT:

Standard

     

TRAVEL:

No

     

MEDICAL SURVEILLANCE:

Not Applicable

     

SIGNIFICANT WORK ACTIVITIES:

Keyboard use (greater or equal to 50% of the workday)

     

     

     

Make every future a success.
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