Process Engineer- Laboratory Engineer

Location

Victoria, TX | United States

Job description

The Process Engineer – Laboratory engineer will provide expertise and technical leadership for laboratory equipment maintenance and troubleshooting. They have technical skills in facility plant/equipment operations, a complete understanding of, and stringent compliance to, GxP, with a good understanding of engineering concepts.

Your Responsibilities

Reporting to the Technical Services Lead – Building Operations and Services you will:

• Actively liaise with contract/service provider management to ensure the site is constantly in an operational and compliant state
• Monitor and track calibration/service status of equipment and controlled environments
• Troubleshoot and resolve operational problems of facility plant and laboratory equipment
• Support plant shutdowns, start-ups and maintenance interventions for laboratory equipment
• Ensure R&D equipment data is current within the Asset Management system
• Generate and manage site wide Service level agreements between CSL R&D and external vendors for critical R&D equipment
• Lead in the response and close-out of utility and equipment-related non-conformance & deviations
• Review and generation of technical diagrams for processes within the CSL Melbourne site
• Respond to in-hours and out-of-hours alarm calls
• Communicate ideas and results succinctly in both written and oral presentations
• Be flexible and adaptable to changing work place priorities
• To support the technical services team, including occasionally assisting other engineering team members
• Ensure high safety standards within the areas of responsibility are taken into account and adhered to as governed by local, state and federal regulations, laws and policies as well as CSL’s policies and directives

Your Experience

• B.E in Chemical/Mechanical or higher degree with experience in pharmaceutical manufacturing or process development relating to recombinant protein manufacturing
• Complete understanding and extensive practical experience in the compliant operation and maintenance R&D laboratories and facilities for investigative medicinal products
• Working knowledge of OGTR and The Department of Agriculture regulations for PC2/QC2 facilities
• Strong planning and co-ordination skills (essential for scheduling user groups and maintenance activities)
• Knowledge of complex engineering services and systems (e.g. WFI, PFS, HVAC)
• Proficient with computerised process control systems (SCADA)
• Developed experience with clean room facilities and practises
• Understanding of facility design
• Understanding of R&D and familiar with the processing operations and associated equipment
• Awareness of various regulatory guidance’s such as PIC/s, FDA, EMEA, ICH and TGA
• Highly skilled in use of MS Office applications, Visio experience preferred
• Ability to collaborate with multiple work-streams operating teams and work effectively under time constraints
• Possess excellent interpersonal skills, both verbal and written.  Must be able to communicate effectively with all levels of management and staff
• Strong writing skills as related to data compilation, document creation and report writing
• Task and team oriented, analytical, organised, detail-oriented, self-motivate and able to multi-task
• Committed to follow through and finishing off tasks
• Able to react well to change, feedback or activity in work place
• Knowledge on process flow diagrams and a basic understanding of piping and instrumentation diagrams (highly preferred)
• Excellent data analysis, trending and reporting/presentation skills

To apply submit your CV no later than 22nd January 2024.

About Us

Our Benefits

We encourage you to make your well-being a priority. It’s important and so are you. Learn more about how we care at CSL.

CSL is a leading global biotechnology company with a dynamic portfolio of life-saving medicines, including those that treat haemophilia and immune deficiencies, as well as vaccines to prevent influenza. Since our start in 1916, we have been driven by our promise to save lives through innovation. Learn more about CSL .

As a global organisation with employees in 35+ countries, CSL embraces diversity, equity and inclusion. Learn more about Diversity, Equity & Inclusion at CSL.

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Salary