Process Engineer III

1 week ago

Toledo, Toledo, United States BioSpace, Inc. Full time
Job Details

A career at Resilience is more than just a job - it's an opportunity to change the future.

We're a technology-focused biomanufacturing company that's changing the way medicine is made.

We're building a sustainable network of high-tech, end-to-end manufacturing solutions to better withstand disruptive events, serve scientific discovery, and reach those in need.



Brief Job Description:


The MSAT Process Engineer III has responsibility for execution of all technical aspects of product and/or process technology transfer to the site through successful completion of PPQ.

This includes feasibility evaluations, design, execution, and documentation of engineering studies, component specification and evaluation, and all other activities required to support delivery of a complete, validated process to manufacturing.

Individuals in this role work closely with Validation, PMO, Supply Chain, Operations, Quality, and technical experts performing transfers to the site to ensure process implementation to commercial manufacturing follows project timelines and corporate standards.

Job Responsibilities:

  • Ensures there is a technical process to internal and external transfers of product throughout the site and to the customer's site.
  • Leads all the continuous process improvement efforts for product movement internal and external to the site.
  • Ensures success criteria for technology transfer and validation is clear and the process is capable for the merge into the Manufacturing/Facility process.


  • Generates a variety of URS, FAT, SAT, commissioning, and IQ/OQ/PQ protocols/reports.
  • Coordinate and support Manufacturing/Facility improvement initiatives that define equipment data, equipment capabilities, utilization, efficiencies, and obsolescence.


  • Maintain external technical relationships and collaborates with equipment and material suppliers.
  • Identify, develop, generate, and manage implementation of appropriate change controls to improve processes and address root causes identified in investigations.


  • Perform and maintain risk management activities for new and existing processes/equipment.
  • Initiates deviations and performs/facilitates the technical investigations and assessment of impacts.


  • Authors and reviews documents including Standard Operating Procedures, Batch Records, Rework procedures, and other forms.


  • Authors and reviews validation and change control documents such as master plans, protocols, summary reports, and change requests.


  • Provides input and develops user requirements for new asset procurement.
  • Provides engineering and project management services.
  • Assist in the development of project justification and engineering proposals including providing input for capital planning process.


  • Identify and support technical training requirements for Operations/Engineering/Maintenance for new and existing processes/equipment.


  • Performs routine validation and periodic reviews activities.
  • Supports and leads technical trouble shooting.
  • On-call support as required.
  • Key contact for regulatory inspections as technical process owner.
  • Participates in annual product review process.
  • Participates in biennial critical systems review process.
  • Responsible for process validation required because of changes to validated processes within Manufacturing.
Minimum Requirements

  • Experience in GMP or regulated production environment.
Preferred Background

  • Bachelor's Degree in Engineering, or related science.
  • Project management.
  • Uses their insight to challenge and adapt current approaches/ways of doing things.
  • Experience in Six Sigma/analytical trouble shooting skills.
  • Experience working in a LEAN manufacturing environment.
  • Expertise in more than one of the following disciplines: automation/controls, aseptic/packaging equipment, process/materials, maintenance, validation.

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