Description:
The client is currently performing PPQ runs and media buffer prep for the manufacturing/production of a biologic drug product involving 12,000 L bioreactors. The client is looking for a Process Engineer SME to assist with process improvements, equipment improvements, troubleshooting of process/equipment related issues, develop technical fixes and direct mechanics and maintenance team to implement solutions. A few examples include investigation and determine the root cause of why a CIP cycle is not running properly, or a bioreactor is not doing what it is supposed to, or a centrifuge is having an issue, etc. The candidate must have strong communication skills to describe the issue/resolution to maintenance team as well as write out the technical issue and report that is GMP compliant and enter into Trackwise system. Must have previous biopharma process equipment and manufacturing experience (~5 years or more).
Technical Responsibilities:
- Process Engineering
- Effectively lead and manage the required deliverables within the scope of assigned project
- Liaise with internal services to ensure needs from maintenance and users are covered.
- Review and challenge design done by third party design companies.
- Ensure that design is fully assessed for applicable safety and quality requirements
- Ensure that technical interfaces are clearly defined and that there are no gaps between the responsible stakeholders
- Prioritize and coordinate activities within assigned field of responsibility
- Revise and develop standards and concepts for process equipment and associated required documentation to be used in future projects
Qualifications:
- Minimum Bachelor s degree or local equivalent in Mechanical, Processor Chemical Engineering
- Experience & Competencies Bachelor s degree + 5 years experience or Master s degree + 2 years in the engineering field, preferably in the pharmaceutical, biopharma industry.
- Functional knowledge of cGMPs and manufacturing operations in FDA regulated facility.
- Experience with biopharmaceutical downstream and upstream processes
- Stainless steal production equipment experience (highly preferred)
Process Engineer SME (237204)
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