Lead of Process Automation
Aegros Therapeutics Pty Ltd, Australia
Job Description
About Aegros
Aegros is Latin for ‘Patient’. We chose this name because it speaks to our focus on the patient. Every day we strive to place the patient first by providing therapeutic plasma products they would not otherwise be able to access.
At Aegros we believe access to life saving therapeutic plasma drugs is a human right and not a privilege. In a nutshell our mission is to put the patients first through innovation.
Over 30 years we have developed our HaemaFrac process which enables countries to turn human plasma they collect into life saving hyperimmune products.
About the role
Reporting to Chief Engineer, this position will be responsible to define and execute the automation strategy for Aegros across all global manufacturing sites. Lead team(s) to implement and maintain automation systems (Process Control Systems, Building Automation Systems, standalone Vendor skid packages, Information Management System, etc.) for all Manufacturing and Utility related functions.
This position resides within the Global Engineering organization, which is accountable for the implementation and maintenance of manufacturing processes and systems enabling the manufacture and release of protein therapeutics.
Key Responsibilities
- Maintenance and administration of GMP automation for manufacturing and utility systems.
- Develop site automation strategy and develop corporate/global automation directives.
- Provide oversight of commissioning and qualification activities for automation systems.
- Develop global automation related councils.
- Lead and develop the global automation teams and mentor to ensure Sites are capable of providing support to cross functional teams including Manufacturing, Engineering, Facilities, and Quality.
- Provide subject matter expertise for process risk assessments and hazards analyses.
- Liaise with Quality Engineering Validation to establish the computer system validation strategy and lead the execution of computer system validation work to ensure compliance with internal and external requirements.
- Ensure automation related changes are compliant with relevant guidance and meet targets for throughput and timeliness.
- Support evaluation of process related deviations and contribute to the development and implementation of corrective actions.
- Collaborate with other teams to deliver cross-functional continuous improvements.
- Coach automation engineers to plan, organize and execute work in alignment with global and site automation strategy. Direct team meetings and activities.
- Manage available resources in alignment with global and site strategies, while ensuring staff assignments are balanced in a healthy and sustainable manner.
- Provide leadership to site teams to support local data owners to perform assessments and to define appropriate Data Integrity controls as part of the design of equipment/systems and processes
- Create and lead the global Data Integrity Leads to ensure proper implementation and sustainment of Roche Pharma Technical Operations Data Integrity requirements.
- Any other assigned duties.
Requirements
- B.S or M.S. in Mechanical Engineering, Chemical Engineering or Electrical Engineering or equivalent degree and relevant work experience/training.
- Minimum 15 years of related experience in support, design and/or implementation of control systems and instrumentation, preferably in the biopharmaceutical or related industries or equivalent. Alternatively, holders with a combination of education and relative work experience including 5 or more years of people management experience in a cGMP environment.
- The candidate must have experience supporting or implementing projects on Control systems. Emerson Delta-V DCS or Rockwell Building Automation System (BAS) experience is a plus.
- Candidate should have a good understanding of Current Good Manufacturing Practice (cGMP), particularly as they relate to the operation, validation and maintenance of computer-controlled systems. Knowledge of biological pharmaceutical production is desirable.
- 5-10 years managing a team with a consistent record of leading multi-functional teams or process automation scope on a capital project.
Benefits
- Supportive and friendly team
- Access to on going training and development opportunity
- Rewarding culture
- Weekly Fruits
- Birthday Celebration