Validation Engineer - 12 Month Contract
We are seeking a talented Validation Engineer to assist in the design, development, project management and qualification of projects.
Summary about this job
Chemical Engineering
Company: IDT Australia Limited
Location: Melbourne
Work type: Full Time
Salary: n\a
Phone: +61-3-3363-7051
Fax: +61-8-5596-3900
E-mail: n\a
Site: n\a
Detail information about job Validation Engineer - 12 Month Contract. Terms and conditions vacancy
- Pharmaceutical Industry
- Eastern Suburbs
We are seeking a talented Validation Engineer to assist in the design, development, project management and qualification of projects.
The successful applicant will be responsible for:
- Design, development, project management and qualification of projects to meet IDT’s strategic plan and operational requirements
- Qualification and routine re-qualification of pharmaceutical facilities, services and process/laboratory equipment
- IT systems and laboratory systems validation
- Preparation and execution of design, installation, operational qualifications and process validation documentation
- Assist with user requirements, functional and design specifications
- Ensuring IDT’s qualification activities and IDT’s Quality System guidance documents meet regulatory requirements
- Reviewing relevant company systems and participate in the internal audit program, and provide positive feedback on areas of continuous improvement of these systems
- Evaluation and calibration of equipment and procedures used in development and manufacturing.
Required Skills and Experience:
- Bachelor of Engineering (Chemical or Mechanical preferred) or Bachelor of Science (with industry experience)
- Strong project management skills including ability to set priorities and manage projects within agreed timeframes
- Experience undertaking validation activities in a pharmaceutical manufacturing environment
- A competent and current working knowledge of GMP and its principles as applied to validation activities for plant, equipment and processes
- High level technical writing skills
- Excellent verbal communication skills.
- Analytical and problem solving skills
- Experience with TGA and FDA highly desirable
For over 30 years, IDT has provided a full scale service from initial API drug development to clinical trials.
Globally, we've worked with 9 of the Top 10 Pharmaceutical companies, bringing a superior level of innovation and expertise to every project, whether cGMP high potency, API manufacture, finished dosage form development and scale-up, analytical testing, clinical packaging, or clinical trials and pharmacy services. Located in Melbourne and Adelaide, Australia our facilities are fully cGMP (GLP, GCP) and are audited by the US FDA and Australia's TGA.