Demo

Project Administrator

TekOne IT Services Pvt. Ltd.
Portsmouth, NH Contractor
POSTED ON 12/9/2024
AVAILABLE BEFORE 4/6/2025
We are seeking a motivated and detail-oriented Project Engineer to join our team. The ideal candidate will play a critical role in improving manufacturing processes, ensuring optimal equipment performance, and supporting plant projects. The position involves providing technical expertise on manufacturing equipment, resolving quality issues, and assisting with the tech transfer of new processes into the facility.

Key Responsibilities

  • Develop and enhance technical knowledge of manufacturing equipment and processes.
  • Provide expert support for equipment troubleshooting, breakdown resolution, and quality issues in manufacturing suites.
  • Serve as a Subject Matter Expert (SME) for process equipment design and operations.
  • Conduct technical analysis, including troubleshooting on equipment, PI data analyses, CIP/SIP circuit reviews, MOC analyses, and flow path assessments.
  • Assist with the transfer of new processes into the manufacturing facility.
  • Modify and develop preventative maintenance plans, including the creation of spare parts.
  • Perform change request lot assessments to support lot release.
  • Plan and execute plant projects involving equipment changes and process improvements.
  • Execute commissioning protocols for installation, operation, and CIP/SIP testing.
  • Own change requests and complete tasks to ensure successful project completion.
  • Collaborate with the Quality department for deviation investigations.
  • Participate in Root Cause Analysis (RCA) processes as the Engineering representative.
  • Complete Corrective and Preventive Actions (CAPA) to address equipment and process challenges.
  • Review and revise Engineering and Manufacturing SOPs, work instructions, and maintenance procedures in response to CAPA, equipment changes, and error prevention initiatives.
  • Conduct engineering review and approval of batch records.
  • Initiate Engineering Document Change Requests (EDCRs) to update documents, including engineering drawings.
  • Author commissioning protocols for equipment testing (installation, operation, CIP/SIP, wet testing).

Qualifications

  • Bachelor's degree in Chemical Engineering, Mechanical Engineering, or a related field.
  • 3-7 years of relevant experience in biotech, pharmaceutical, or fluid processing/manufacturing industries.
  • Strong analytical and troubleshooting skills related to manufacturing processes and equipment.
  • Familiarity with equipment commissioning, preventive maintenance, and process improvement.
  • Proficiency in handling documentation, SOPs, and compliance with industry standards.
  • Excellent communication and collaboration skills for cross-functional teamwork.
  • Experience in resolving major equipment breakdowns and quality issues, with a focus on tech transfer and process optimization.

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