FCC Engineer
Entity: CSL Seqirus
Job Category: Manufacturing Operations
Job Family: Production
Job Type: Full Time
Location: Tullamarine, Victoria, Australia
Employer Reference: R-277678
Job Description
CSL Seqirus is a global leader in influenza prevention and pandemic preparedness. We are seeking an Engineer to provide production engineering support within the Pharmaceutical Operations area.
The Opportunity:
We are seeking an experienced Engineer to join our Flu Cell Culture Engineering team on a 12-hour rotating shift pattern. You will plan work in accordance with cGMP and CSL Seqirus Quality Management systems and drive process improvement initiatives to help meeting business goals.
Key Responsibilities:
The FCC shift engineer is responsible for providing on-shift technical support for manufacturing operations.
Investigate, evaluate, promote and implement methods to improve process and facility reliability, functionality and efficiency, while ensuring that the requirements of cGMP manufacturing are maintained
Support troubleshooting of manufacturing and cleaning processes
Work closely with the production team – troubleshooting and reviewing trends, why technical issues are occurring and measures that can be implemented
Experience and Qualifications:
Essential Qualifications/Experience:
Degree qualified in an engineering discipline (preferably Chemical, Mechanical, or Process Engineering)
3-5 years of experience in a related engineering role
Microsoft applications (Word, Excel)
Experience in a Pharmaceutical or Manufacturing environment
Technical understanding of pharmaceutical manufacturing processes, particularly clean-in-place and steam-in-place processes
Strong mechanical aptitude including understanding of operation of valves, pumps, agitators, vessels, compressors, etc.
Knowledge of cGMP/GMP/TGA (PIC/s)/FDA/EU/OGTR/DAFF/EMA regulations
Knowledge of Quality Management Systems
Strong customer focus and ability to work collaboratively with internal customers.
Ability to work autonomously under pressure to meet production deadlines
Demonstrated ability to work without supporting engineering staff (e.g. while on night shift). This is Essential.
Preferred Qualifications/Experience:
SAP, LIMS, Trackwise, MES, Veeva and LMS
Practical, "on the tools” maintenance experience, would be advantageous
Understanding of cell culture processes
This role would suit someone who enjoys solving complex problems end‑to‑end, is confident working autonomously as the sole engineer on shift and can act as the lead technical expert when required. Experience working closely with trades and a genuine passion for engineering and continuous improvement are essential.
About CSL Seqirus
CSL Seqirus is part of CSL. As one of the largest influenza vaccine providers in the world, CSL Seqirus is a major contributor to the prevention of influenza globally and a transcontinental partner in pandemic preparedness. With state-of-the-art production facilities in the U.S., the U.K. and Australia, CSL Seqirus utilizes egg, cell and adjuvant technologies to offer a broad portfolio of differentiated influenza vaccines in more than 20 countries around the world.
To learn more about CSL, CSL Behring, CSL Seqirus and CSL Vifor visit https://www.csl.com/ and CSL Plasma at https://www.cslplasma.com/.
Our Benefits
For more information on CSL benefits visit How CSL Supports Your Well-being | CSL.
You Belong at CSL
At CSL, Inclusion and Belonging is at the core of our mission and who we are. It fuels our innovation day in and day out. By celebrating our differences and creating a culture of curiosity and empathy, we are able to better understand and connect with our patients and donors, foster strong relationships with our stakeholders, and sustain a diverse workforce that will move our company and industry into the future.
To learn more about inclusion and belonging visit https://www.csl.com/careers/inclusion-and-belonging
Equal Opportunity Employer
CSL is an Equal Opportunity Employer. If you are an individual with a disability and need a reasonable accommodation for any part of the application process, please visit https://www.csl.com/accessibility-statement.