Process Project Specialist

3 weeks ago

Melbourne, Victoria, Australia Integrated Project Services Full time

Job Summary

Integrated Project Services (IPS) is seeking a highly skilled Process Project Specialist to join our team. As a Process Project Specialist, you will play a critical role in the development and execution of projects related to pharmaceutical and biotechnology facilities.

Key Responsibilities

  • Develop a thorough understanding of prime contract requirements and apply knowledge to project activities.
  • Support the Lead Process Engineer in the development and maintenance of preconstruction, construction, and closeout execution plans.
  • Coordinate review and approval from the Lead Process Engineer and communicate this information to the project team.
  • Support the Lead Process Engineer in the development and maintenance of written project scopes of work and communication of this information to the project team.
  • Support the Lead Process Engineer in facilitating communication between project participants and producing documentation of communication between project participants.
  • Develop a working knowledge of the scope of the project budget and identify exceptions to the project budget throughout the execution of the project.
  • Participate in Safety reviews and/or Pre-planning / JSA meetings as necessary.
  • Review all shop drawings and submittals and ensure that the submittals and shop drawings are in conformance with the design before submission to the design professional.
  • Assist with Punch List management.
  • Assist the Lead Process Engineer in completing the close-out requirements and Turnover Documents (TOPs).
  • Support the Lead Process Engineer in monitoring and reporting project costs.
  • Support the Lead Process Engineer in the development of change control documentation and related financial documentation.
  • Develop a thorough understanding of contractually required quality in design and construction and support quality assurance for the project.
  • Support the Lead Process Engineer in the coordination of safety resources to monitor site safety and correct nonconformances.
  • Monitor design content and quality and coordinate design revisions for constructability and compliance with basis documents, schedule, and budget.
  • Support the Lead Process Engineer in the procurement and coordination of all required project resources, including intra-divisional, interdivisional, and extra corporate.
  • Support the Lead Process Engineer in the preparation of subcontracts, purchase orders, change control documentation, and related financial documentation.
  • Support the Lead Process Engineer in the evaluation of vendor and subcontractor invoices.
  • Work with Document Control to ensure that all project documents are distributed, reviewed, and stored to meet project and corporate requirements.
  • Support the Lead Process Engineer in ensuring compliance of project activities with legal and regulatory requirements.
  • Coordinate resources to achieve project goals.
  • Interact with clients on assigned projects and promote positive relationships.

Requirements

  • Bachelor's degree in Engineering, Validation, or a related discipline or an equivalent technical degree.
  • 5+ years of experience in Engineering, Validation, or a related discipline within the Life Sciences industry.
  • Knowledge of cGMPs as they affect process design and equipment specification.
  • Strong Process and Validation knowledge of BioPharma Life Science equipment, regulatory cGMP knowledge.

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