Process Validation Engineer at IDT Australia
Boronia VIC 3155, Victoria, Australia -
Full Time


Start Date

Immediate

Expiry Date

14 Jun, 25

Salary

45.0

Posted On

14 Mar, 25

Experience

2 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

No

Skills

Process Engineering, Gmp, Regulatory Documentation, Ema, Pharmaceutical Manufacturing, Training, Technology Transfer, Technical Writing, Tga, Regulatory Requirements

Industry

Mechanical or Industrial Engineering

Description

We are seeking a Process and Validation Engineer, for immediate start, to support a 3-4 month project.
The Process and Validation Engineer, plays a critical role in process engineering, technology transfer, and commissioning, qualification, and validation (CQV) activities within IDT’s sterile filling and API manufacturing operations. This role is essential in ensuring smooth handover from Engineering & R&D to Operations, with a strong focus on process optimization, training, and production support.

Key Results Areas:

  • Completion of process validation & qualification activities within project timelines.
  • Successful handover of validated processes to Operations, ensuring minimal disruptions.
  • Development of robust training programs that improve operational readiness.
  • Reduction in process deviations and downtime due to engineering improvements.
  • Adherence to GMP and regulatory compliance requirements.

Qualifications & Experience:

Minimum requirement:

  • Bachelor’s degree in Engineering (Chemical, Mechanical, Process, or related field).
  • 2-3yrs Experience in process engineering & CQV within a sterile filling and API manufacturing environment.
  • Strong understanding of GMP, regulatory requirements (TGA, FDA, EMA), and validation principles.
  • Ability to lead process handover & training programs, ensuring seamless technology transfer.
  • Proficiency in technical writing, process mapping, and regulatory documentation.

A police check will be required.
Candidates, must have full working rights in Australia and available for immediate start.
Job Type: Casual
Pay: $40.00 – $45.00 per hour
Expected hours: 30 – 40 per week

Schedule:

  • Day shift

Education:

  • Bachelor Degree (Required)

Experience:

  • Process engineering: 2 years (Required)
  • Pharmaceutical Manufacturing: 2 years (Required)

Work Authorisation:

  • Australia (Required)

Work Location: In person
Expected Start Date: 24/03/202

Responsibilities

Please refer the Job description for details

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