Advertiser: IDT Australia LimitedMore jobs from this company
- Job Listing Date
- 25 Mar 2020
- Melbourne, Eastern Suburbs
- Work Type
- Full Time
- Engineering, Project Engineering
The successful applicant will be responsible for:
- Design, development, project management and qualification of projects as directed by the Manager to meet IDT’s strategic plan and operational requirements.
- Assist and prepare where required installation qualifications, operational qualifications and process qualifications/validations, user requirements, functional specifications and design specifications, ensuring all elements can be qualified to meet current regulatory and in-house requirements.
- Ensuring IDT’s qualification activities and IDT’s Quality System guidance documents meet regulatory expectation at any point of time and are sufficiently flexible to accommodate changes in the regulatory outlook for qualification.
- Ensuring work carried out by staff under the Projects Engineer’s responsibility will be of a standard appropriate for a quality pharmaceutical manufacturer and supplier, meeting statutory, and company requirements.
- Review relevant company systems, and provide positive feedback on areas of continuous improvement of these systems.
The role provides front line technical expertise across IDT’s operations and will actively seek opportunities to maximise productive time. Further, in conjunction with the Manager, the Project Engineer will review and continuously improve the GMP systems which involve the Infrastructure group.
Required Skills and Experience:
- A qualification in electrical, mechanical or production engineering.
- Extensive experience in the management and project management of engineering projects in a highly regulated pharmaceutical or similar environment.
- Management of trade personnel and contractors to ensure deliverables are met in a safe, cost effective manner.
- Preparation and management of budgets.
- Excellent verbal and written communication skills.
- High level analytical and problem solving skills
- Experience with TGA and FDA highly desirable
Founded in 1975, IDT Australia is an award-winning, publicly-listed Australian pharmaceutical manufacturing company, based in Boronia Victoria. Partnering with pharmaceutical leaders IDT specialises in the development and the commercial manufacture of high potency active pharmaceutical ingredients (API) and finished drug products for national and international distribution. IDT's culture is built on the success of its people. At IDT we value accountability, leadership, curiosity, quality, innovation and driving results.
- Which of the following statements best describes your right to work in Australia?
- How many years' experience do you have as a project engineer?
- Have you completed a qualification in engineering?
- What's your expected annual base salary?
- How much notice are you required to give your current employer?