Process Project & Validation Engineer
Integrated Project Services
- Melbourne, VIC
- Permanent
- Full-time
- Develops working knowledge of prime contract requirements and applies knowledge to project activities.
- Strong Process and Validation knowledge of Bio Pharma Life Science equipment, regulatory cGMP knowledge
- Supports the Lead Process Engineer in the development and maintenance of preconstruction, construction, and closeout execution plans. Coordinates review and approval from Lead Process Engineer and communicates of this information to project team.
- Supports Lead Process Engineer in the development and maintenance of written project scopes of work and communication of this information to project team.
- Supports the Lead Process Engineer in facilitating communication between project participants and produces documentation of communication between project participants. Supports the Lead Process Engineer in the development and maintenance of project schedules, including targeted and actual activities lists, durations, and sequencing logic and communicates this information to the project team.
- Develops a working knowledge of their scope of the project budget and identifies exceptions to the project budget throughout execution of the project.
- Participates in Safety reviews and / or Pre-planning / JSA meetings as necessary.
- Review of all shop drawings and submittals and ensure that the submittals and shop drawings are in conformance with the design prior to submission to the design professional.
- Assist with Punch List management.
- Assist the Lead Process Engineer in completing the close-out requirements and Turnover Documents (TOP’s).
- Supports the Lead Process Engineer in monitoring and reporting project costs.
- Supports the Lead Process Engineer in the development of change control documentation and related financial documentation. Vigorously protects corporate positions.
- Develops a thorough understanding of contractually required quality in design and construction and supports quality assurance for the project.
- Supports Lead Process Engineer in coordination of safety resources to monitor site safety and correct nonconformances.
- Monitors design content and quality and coordinates design revisions for constructability and compliance with basis documents, schedule, and budget.
- Supports Lead Process Engineer in the procurement and coordination of all required project resources, including intra-divisional, interdivisional, and extra corporate.
- Supports the Lead Process Engineer in the preparation of subcontract, purchase order, and change control documentation and related financial documentation.
- Supports the Lead Process Engineer in the evaluation of vendor and subcontractor invoices.
- Works with Document Control to ensures that all project documents are distributed, reviewed, and stored to meet project and corporate requirements. Project documents include records of communications, design documents, bid packages and addenda and bulletins thereto, and submittals, among others.
- Supports the Lead Process Engineer in ensuring compliance of project activities with legal and regulatory requirements.
- Coordinates resources to achieve project goals.
- Interacts with clients on assigned projects and promotes positive relationships.
- Other duties as assigned.
- Bachelor’s degree in Engineering, Validation or a related discipline or an equivalent technical degree.
- A minimum of 5+ years of experience in Engineering, Validation or a related discipline within the Life Sciences industry.
- Knowledge of cGMP’s as they affect process design and equipment specification.