What are the responsibilities and job description for the Process Engineer III position at Katalyst Healthcares & Life Sciences?
Company Description
- Katalyst Healthcares & Life Sciences is hiring entry level candidates for several positions for contract research in Clinical trials of drugs, biologics and medical devices.
- We have a few immediate job opportunities available in Drug Safety and Pharmacovigilance and Clinical Research field. We work with University hospitals, pharmaceutical companies and recruiting partners.
Job Description
Responsibilities:
- 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.
- Planning and execution of plant projects involving equipment changes and process improvements.
- Execute commissioning protocols (installation, operation, CIP/SIP, wet testing) with support and guidance from supervisor.
- Review/revise Engineering and Manufacturing related SOP’s, 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).
Requirements:
- B.S Chemical or Mechanical Engineering.
- 3 - 7 years of experience in manufacturing, process engineering, or equipment support.
- Support Investigation and Implementation of Process/Equipment/Automation Design Changes as a result of new customer first run at scale runs.
- Changes driven through Workfront.
- Own or Influence Changes driven through change control.
- CAPEX Project Support.
- Buffer Valve Array Drain Hard Pipe.
- IBF to SMCC Hardpipe.
- SMCC Filter Housing Upgrade.
- EM Conflict Resolution.
- VRF Skid Commissioning.
Additional Information
All your information will be kept confidential according to EEO guidelines.
