Computer System Validation Regional Lead Apac

2 days ago

Parkville, Australia CSL Behring Full time

**The Opportunity**:
The Computer System Validation Regional Lead provides oversight of the development of Computerised System Validation (CSV) deliverables for control systems within Execution Systems (ES) and interfaces.

You'll maintain the validated status of ES platforms for manufacturing sites in addition to managing our site CSV teams in the APAC region.

To be completed in 2026, our CSL Seqirus facility at Tullamarine (Project Banksia) will be the only cell-based influenza vaccine manufacturing facility in the Southern Hemisphere and we also produce unique products important to Australia's public health needs such as snake and spider antivenoms.

**The Role**:
Reporting to the Execution Systems Global CSV Lead you will:

- Oversee the design, modification, development, authoring, review, and implementation of all Computer System Validation (CSV) documents, protocols, and reports for validation and qualification work.
- Ensure CSV/cGMP/Regulatory compliance, including internal SOP's, departmental standards and conventions for the designated region
- Provide guidance for developing CSV deliverables, addressing the System Development Life Cycle (SDLC), such as Validation Planning, URS, SDS, Testing, Traceability Matrix, and Final Reporting for industrial control systems including SIMATIC PCS 7, distributed control system, PLCs, and SCADA.
- Participate in assessing system reviews, deviations, CAPA, Changes, continuous improvement, and troubleshooting related to Global ES Systems and Applications.
- Monitor compliance adherence of ES platforms both globally and locally with the sites.
- Coordinate CSV/SDLC training to ES teams.
- Contribute to the global CSV strategy

**Your skills and experience**:

- Bachelor's Degree in Engineering, Computer Sciences or similar field
- At least 7 years' experience with CSV methodologies in operation IT, OT, and Automation position with an understanding of pharma, biotechnology, chemistry, and food industries
- Working knowledge of software development lifecycle (SDLC) model and validation practices of multiple computerised systems
- Experience with Automation and MES projects and computer validation methodologies
- Experience in writing, reviewing and building CSV documentation (IQ, OQ, PQ)
- You'll demonstrate working knowledge of industry standards related to computerised systems and Electronic Records/Electronic Signatures: 21 CFR Part 11, Part 820, Annex 11, GAMP5, both S88 and ISA 95 standards and applicability to CSV

Applications close Monday 10th October.

**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.

**About CSL Behring**:
CSL Behring is a global leader in developing and delivering high-quality medicines that treat people with rare and serious diseases. Our treatments offer promise for people in more than 100 countries living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. Learn more about CSL Behring.

**We want CSL to reflect the world around us**:
As a global organization with employees in 35+ countries, CSL embraces diversity and inclusion. Learn more about Diversity & Inclusion at CSL.

**Do work that matters at CSL Behring**:

  • Validation Manager

    1 week ago

    Parkville, Australia Seqirus Full time

    **The Opportunity**: **CSL Seqirus**, part of the CSL family, manufactures Products of National Significance (PNS) and Other Non-IVV (non-influenza) including anti-venoms, anti-toxins and Q-fever vaccinations. We are focused on saving lives all around the world through innovation and global collaboration. We are looking for an experienced **Validation...

  • Validation Manager

    1 week ago

    Parkville, Australia Seqirus A CSL Company Full time

    The Opportunity CSL Seqirus, part of the CSL family, manufactures Products of National Significance (PNS) and Other Non-IVV (non-influenza) including anti-venoms, anti-toxins and Q-fever vaccinations. We are focused on saving lives all around the world through innovation and global collaboration. We are looking for an experienced Validation Manager to join...

  • Research Fellow in Computer Science

    2 weeks ago

    Parkville, Victoria, Australia University of Melbourne Full time $87,266 - $118,416 per year

    Role type: Fixed Term until the end of September 2027Faculty:  Faculty of Engineering and Information TechnologyDepartment/School: School of Computing & Information SystemsSalary: Level A - $87,266 - $118,416 per annum (pro rata for part time) plus 17% superannuationAdvance your research career in a supportive environment / Collaborate with a growing...

  • Research Fellow in Computer Vision

    1 week ago

    Parkville, Australia University of Melbourne Full time

    **Research Fellow in Computer Vision**: **Position Number**: 0063971 **Location**: Parkville **Role type**: Full-time - Fixed Term 2 years **Faculty**: Faculty of Engineering and Information Technology **Department/School**: School of Computing and Information Systems **Salary**: Research Fellow Grade 2 (Level B) - $119,231 - $141,581 p.a. plus 17% super -...

  • HRis Systems Lead

    6 days ago

    Parkville, Australia The Royal Melbourne Hospital Full time

    Job Description - HRIS Systems Lead **Req ID**:2646 **Posting Start Date**:03/02/2025 **Advertisement End Date**:10/02/2025 **Work Location**:The RMH Elizabeth Street The Royal Melbourne Hospital is one of Australia’s leading public healthcare providers. Join the team. Build a career. We are looking for a passionate and dedicated individual to join...

  • Postdoctoral Research Fellow in Intelligent Photonic Networking and Computing

    6 days ago

    Parkville, Australia University of Melbourne Full time

    **Postdoctoral Research Fellow in Intelligent Photonic Networking and Computing**: **Position Number**: 0064564 **Location**:Parkville **Role type**:Full-time; Fixed-term Research - Focused for 5 years **Faculty**:Engineering & Information Technology **Department/School**:Electrical And Electronic Engineering **Salary**:Level B $119,231 - $141,581 p.a. (pro...

  • Regional Engagement Officer

    1 week ago

    Parkville, Australia University of Melbourne Full time

    **Job no**: 0062383 **Location**: Parkville **Role type**: Part-Time (0.2 FTE) Fixed-term until 31st Match 2026 **Faculty**:Faculty of Education **Salary**: UOM 6 - $92,749 - $100,397 p.a. (Pro rata) plus 17% super - **Build strategic partnerships with regional schools and community stakeholders to nurture and support pre-service teachers through invaluable...

  • Regional Engagement Officer

    1 week ago

    Parkville, Australia University of Melbourne Full time

    **Job no**: 0062358 **Location**: Parkville **Role type**: Part-Time (0.2 FTE) Fixed-term until 31st Match 2026 **Faculty**:Faculty of Education **Salary**: UOM 6 - $92,749 - $100,397 p.a. (Pro rata) plus 17% super - **Build strategic partnerships with regional schools and community stakeholders to nurture and support pre-service teachers through invaluable...

  • Regional Engagement Officer- Wodonga

    1 week ago

    Parkville, Australia University of Melbourne Full time

    **Job no**: 0062384 **Location**: Parkville **Role type**: Part-Time (0.2 FTE) Fixed-term until 31st Match 2026 **Faculty**:Faculty of Education **Salary**: UOM 6 - $92,749 - $100,397 p.a. (Pro rata) plus 17% super - **Build strategic partnerships with regional schools and community stakeholders to nurture and support pre-service teachers through invaluable...

  • Regional Engagement Officer

    1 week ago

    Parkville, Australia University of Melbourne Full time

    **Job no**: 0062360 **Location**: Parkville **Role type**: Part-Time (0.2 FTE) Fixed-term until 31st Match 2026 **Faculty**:Faculty of Education **Salary**: UOM 6 - $92,749 - $100,397 p.a. (Pro rata) plus 17% super - **Build strategic partnerships with regional schools and community stakeholders to nurture and support pre-service teachers through invaluable...