Overview:
TekWissen group is a workforce management provider throughout the USA and many other countries in the world. Our client is a leading biotechnology company that combines technological insight with worldclass manufacturing scientific expertise and process excellence and helps their customers to deliver new and innovative medicines that help treat a wide range of diseases. Our client specializes in pharmaceutical ingredients Bioscience Biopharmaceuticals Custom manufacturing Biotechnology Life science ingredients Nutrition Microbial Control Agriculture Materials Science Personal Care and cell and gene therapy.
Job Title: Manufacturing Process Engineer
Location: Portsmouth NH 03801
Duration: 8 Months
Job Type: Contract
Work Type: Onsite
General Deliverables / Responsibilities:
Manufacturing Support
- Develop technical knowledge on manufacturing equipment and processes
- Support resolution of major equipment breakdowns and quality issues in the suites
- Provide SME support to Manufacturing and other departments for the design and operation of process equipment.
- Conduct troubleshooting and technical analyses on manufacturing equipment and processes including PI data analyses CIP/SIP circuit review MOC analyses flow path analyses etc.
Projects
- Planning and execution of plant projects involving equipment changes and process improvements.
- Execute commissioning protocols (installation operation CIP/SIP wettesting) with support and guidance from supervisor
Documentation
- Review/revise Engineering and Manufacturing related SOPs work instructions and maintenance assessments/procedures as a result of CAPA equipment/process changes error prevention activities etc.
- Complete engineering review/approval of batch records
- Initiate EDCRs for updates to Engineering documents including engineering drawings
- Author commissioning protocols (installation operation CIP/SIP wet testing).
Specific Deliverables
- Investigate and Implement Process/Equipment/Automation Design Changes as a result of 5205/5208 FRAS
- Changes driven through WorkFront
- Own or Influence Changes driven through change controls
- 5220 Tech Transfer OOF 08Apr25
- Delivery and Design
- Recipe Development Design and Execution 25 20 days
- Automation Configuration Specification Review & Approval
- Chrom Skid Flow Path Analysis Generation & Approval
- eBR Parameter Review & Approval
- Batch Record Review & Approval
- 5209 Scale Lump Sum Closure
- Incorporate Flow processing and cleaning flow paths into equipment functional specifications
- Automate CS Drain Hand Valve for SMCC and XFER73500 SIP Circuits
- Change Control Ownership
- Project Ownership & Execution
Required Skills
- 3 to7 years of prior experience
- B.S Chemical or Mechanical Engineering
- Biotech or Fluid Processing/Manufacturing
TekWissen Group is an equal opportunity employer supporting workforce diversity.