Epicareer Might not Working Properly
Learn More

Project Engineer

Salary undisclosed

Apply on


Original
Simplified
  • Independent Project Execution: Work independently while interfacing with engineers to execute project tasks with minimal oversight.
  • Technical Expertise: Provide technical guidance and resolve challenges during project execution.
  • Documentation: Prepare and review design documentation packages, vendor turnover packages, and FAT/SAT documentation.
  • Engineering Studies: Conduct engineering studies, assess schematic designs, and analyze operational efficiency.
  • Drawings Interpretation: Interpret P&IDs and electrical drawings, verifying their accuracy.
  • Validation Leadership: Lead validation efforts for the installation and commissioning of all water room equipment.
  • FAT/SAT Participation: Participate in FAT and SAT activities, addressing discrepancies and resolving issues.
  • Project Support: Support ongoing site project initiatives as needed.
  • Cross-functional Collaboration: Collaborate with engineering, quality control, microbiology, quality assurance, and production teams to coordinate validation activities.
  • Industry Knowledge: Stay updated with industry trends, regulatory changes, and technological advancements related to water systems and utilities.
  • Validation Project Planning: Develop and implement validation project plans.

Qualifications:

  • Educational Background: Bachelor's degree in Engineering or a related field.
  • Industry Experience: Prior experience in pharmaceutical, biotech, nutraceutical, or life science industries.
  • Systems Expertise: Strong knowledge of pretreatment systems, steam generators, WFI systems, HVAC systems, and their validation.
  • Risk Management: Ability to perform risk assessments and apply mitigation strategies for utility systems.
  • Utility Systems Knowledge: Experience working with medium voltage systems and electrical hazardous classified areas.
  • Regulatory Knowledge: Familiarity with regulatory requirements and industry standards (FDA, GMP) for water systems in aseptic processing.
  • Problem-solving Skills: Excellent analytical and problem-solving capabilities.
  • Communication Skills: Strong communication and interpersonal skills for effective collaboration with cross-functional teams.
  • Project Management: Solid organizational skills with the ability to manage multiple validation projects simultaneously.

Validation Scope of Work:

  • Commissioning Support: Assist with vendor execution/start-up and generate/approve commissioning reports for systems including WFI generation, storage, distribution, boilers, chillers, air handlers, and clean steam.
  • IOQ Protocol: Generate, execute, and approve IOQ protocols for WFI generation, storage, distribution, and clean steam.
  • Final Reports: Prepare and approve IOQ and PQ final reports.
  • PQ Protocols: Develop and approve PQ protocols for WFI and clean steam systems.

Assumptions:

  • PQ Sampling: Performed by the end user.
  • Turnover Documentation: Ensure vendor documentation is complete and accurate.
  • SAT and Start-Up: Performed by vendors.
  • Testing Equipment: Provided by the end user.
  • Onboarding: 40 hours of onboarding for each team member.
  • Onsite Requirement: Flexibility to be onsite 100% of the time; manage onsite/offsite work during project execution.
  • Validation Leadership: Lead and participate in validation activities as part of staff augmentation.