Manufacturing Process Engineer

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Irfa******

  • Australia 
  • Last Update: 31.10.2018 at 12:00

Job Type
Full Time
Start
ASAP
Duration
31 Month +
Place
Inner Suburbs Perth, Australia
Country
Australia

Category


Clinical and medical development

Description


Qualifications and experience required:
BS/BA, preferably in Electrical or Mechatronics Engineering and / or Practical Engineering experience in the pharmaceutical or manufacturing industry for 7 or more years.
Prior experience leading the design, programming, start-up, and troubleshooting of process control systems including PLCs and HMIs.
Strong planning and project management skills.
Ability to manipulate and create CAD drawing files.
Strategic thinker with the ability to concisely articulate and justify business concepts.
Adept at brainstorming with a group or acting as an independent thinker.
Experience in successfully developing and implementing policies, procedures and best practices.
Effective and proactive communicator with the ability to build consensus, influence and negotiate.
Excellent written, verbal, and graphical (PowerPoint) communication skills.
Prior manufacturing or development process instrument engineering experience in pharmaceutical industry.
Familiarity with Good Manufacturing Practice, TGA and FDA guideline for large scale processing including secondary manufacturing such as sterilization, vial filling lines, and packaging equipment.
Familiarity with regulatory expectations regarding electronic records and electronic signatures.
Ability to follow written procedures and document results in a neat and precise manner.
Excellent computer skills.
Any experience with machine vision systems will be highly regarded.

Key Responsibilities include the following:
Process automation programming, troubleshooting, and qualification.
Supports Production in investigations and troubleshooting.
Author's Qualification protocols as required.
Provide budgetary estimates for proposed automation systems and upgrades.
Establish plans for system execution and installation.
Interface with vendors and sub-contractors.
Performs triennial SOP reviews as required.
Performs gap analysis of local SOPs. Other tasks as assigned by the Flow Team Manager.
Perform system diagnostics of automation systems as necessary.
Responsible for identifying and managing high value cost and time savings to the department.
Contributes to creation of new processes to improve efficiency and cost savings
Learn to recognize problems and inefficiencies in processes and methods, then proposes and implements improvements
Collaborate with managers within the Capital Projects Engineering group to ensure the mission, objectives, and strategies are executed consistently.
Ensure CAD drawing files are accurate and kept up to date.
Environment Health

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