Description:
**Candidates must have 10 years of experience, lead beginning to end (project lifecycle) & must have Pharma/GMP regulated industry experience.
Actual Job Title: Project Engineer
* Looking for candidates with CAPEX project management experience and experience in pharma/regulated industry
Below are a few requirements for the role in addition to the details already in the req:
- Experience working on operational sites regulated by regulatory agencies, e.g. FDA, EMEA, TGA, etc.
- Executed projects in the role of project manager and/or project engineer in regulated sites
- Proactive approach, accountable for successful execution or capital projects
- Team work, collaboration
- Lead and/or facilitate meetings effectively
- Conflict resolution
Summary:
The Project Engineer role supports ongoing Client operations by providing technical leadership as it relates to manufacturing and process systems. The role acts as a technical resource to operations customers to ensure that equipment and facilities are designed, operated, and maintained to meet production needs. Responsibilities of the role include implementation of engineering projects to support manufacturing requirements.
Manufacturing Support
Provide SME support to Manufacturing and other departments for the design and operation of process equipment, and facility (i.e. clean room) modifications
Modify/develop preventative maintenance plans and create spare parts
Leadership
Effectively communicate progress and opportunities (i.e. roadblocks) to stakeholders.
Supervising (as required)
Manage project contractors
Projects
Planning and execution of plant projects involving equipment changes and process improvements including lump sum ($220K) and CAR ($220K) capital projects
Execute commissioning protocols
Own change requests and complete change request tasks to support project completion
Perform change request assessments
Project Manager in the design and realization of the project until hand-over to operations in accordance with SOPs.
Coordination of all technical disciplines involved including 3rd Parties
Actively coordinates day to day activities with site resources to ensure no impact on al project activities.
Project Manager to reach the project goals in terms of cost, time and functionality.
Manage project progress, and escalation of issues.
Coordination of Process Equipment specifications, URS, procurement, document control, receiving, installation and support CQV Manager.
Support CQV Manager with Facility and equipment IOQ plan and process.
Coordinate with Client stakeholders on day to day project execution requirements in regards to Operations, Facility Engineering and Quality.
Training
Remain up to date on all assigned training activities including SAP Learning Portal (95%), Compliance (no overdue), and iComply (no overdue).