To support in execution of the Project involving management of clean utility design and CQ planning and execution.
Package owner of the Clean Utilities equipment / systems (Water for Injection, Clean Steam, Process Gases and other systems).
Review and approve drawings, lists, schedules, diagrams, layouts, calculations, and datasheets in project.
Perform new equipment FAT / SAT / inspections in project.
Lead the system commissioning up to final handover of the systems to the user.
Execution of commissioning tests, together with commissioning field teams; including non-Q relevant as well as Q -relevant tests.
Manage project deficiencies and deviations.
Manage remediation activities.
Reviewing the commissioning test reports and ensuring their completeness.
Interface with the different stakeholders within the organization to ensure integrity
All project issues are tracked and managed and history of all decisions and actions are recorded accurately and clearly for future reference.
Alignment on issues is agreed with different stakeholders within the team.
Decisions are made in a timely manner which aligns to the project schedule.
Communication is done with the relevant stakeholders when any project work will impact them.
Coordinate regular and adhoc meetings with the various stakeholders within and outside of organization. Work closely with the EPCM Contractor on the project to track and resolve issues.
Report issues to the Project Manager which need to be escalated as no resolution is clear with the stakeholders internally
Qualification:
Degree in Engineering or Equivalent. Diploma/Degree in Process Engineering is preferred.
3+ yrs. experience as Clean Utilities Lead with experience in pharmaceutical sector is preferred.