Position Details
Project Engineer Apply
- 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.
- 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.
- 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.
- 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.
