Manager, Global Quality Engineering C&q

2 months ago

Broadmeadows, Australia CSL Behring Full time

The Manager, Global Quality Engineering Commissioning & Qualification is responsible for quality oversight of GMP compliant commissioning and qualification of utilities and production facilities, equipment, and cleanrooms for CAPEX and OPEX projects (local and global). This includes review and approval of all user requirements, risk assessments, protocols and reports related to commissioning and qualification activities.

The incumbent will be the Quality partner to the teams within of Global Engineering and work closely with members of Global Engineering. The incumbent will work closely with his or her peers in Quality Engineering, Site QA as well as QA-Sterility Assurance across the different manufacturing sites and ensure that the same principles and systems are applied across all CSL Behring manufacturing sites and that in all projects, the appearance of the documentation in the stated areas is standardized.

**Your role**:
Reporting to the Associate Director Global Quality Engineering Lead you will ensure GMP-compliant planning and implementation of projects in the area of Commissioning & Qualification:

- Perform QA activities, including issue and risk management for local and global CAPEX and OPEX projects in the area of Commissioning & Qualification
- Provide a consistent quality approach to utilities, production facilities, equipment, and cleanrooms, with attention to process design
- Ensure GMP compliant execution of commissioning and qualification activities in accordance with approved project plans within required timelines and in compliance with internal and regulatory requirements (EU, TGA, FDA)
- Quality oversight and approval of risk analysis, user requirements (URS), factory acceptance testing (FAT), on-site acceptance testing (SAT), and DQ/IQ/OQ/PQ plans and reports as part of local and global CAPEX and OPEX projects
- Plan, coordinate, and monitor resource allocation in consideration of the project plan and CSL priorities
- Ensure that internal guidelines and global standards (quality systems, policies, procedures and work instructions) in the area of responsibility comply with regulatory requirements and industry standards
- Ensure that internal guidelines (SOPs) and global engineering standards are implemented in accordance with quality requirements in the area of Commissioning & Qualification.

**Experience**:

- Degree in life sciences and/or engineering; Advanced degree preferred.
- 5+ years of experience as a professional in the pharmaceutical industry or equivalent combination of education and experience.
- Demonstrated experience in quality assurance and regulatory compliance with GxP, FDA, TGA, EU, and other regulatory agency guidelines and in manufacturing of biologics
- Direct experience in quality oversight of GMP-compliant commissioning and qualification of production facilities, equipment, and cleanrooms
- Experience in interacting with regulatory authorities including submissions and inspections
- Demonstrated ability to influence at all organizational levels through clear, concise and impactful communication skills

This role is offered as a 12 month fixed term contract and a secondment may also be considered.

**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 organisation with employees in 35+ countries, CSL embraces diversity and inclusion. Learn more about Diversity & Inclusion at CSL.

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

  • Production Technician- Pns

    3 months ago

    Broadmeadows, Australia Seqirus A CSL Company Full time

    CSL Seqirus is hiring for a Product Technician - PNS (Product of National Significance) in our Q Fever manufacturing department at the Broadmeadows site. The Product Technician will support and participate the production of and Q Fever Vaccines in accordance with process specifications, cGMP and Seqirus Quality Management Systems. Where required the role...

  • Production Technician- Pns

    3 months ago

    Broadmeadows, Australia Seqirus Full time

    CSL Seqirus is hiring for a **Product Technician - PNS (Product of National Significance)** in our Q Fever manufacturing department at the Broadmeadows site. The** Product Technician** will support and participate the production of and Q Fever Vaccines in accordance with process specifications, cGMP and Seqirus Quality Management Systems. Where required...

  • Process Engineer

    22 hours ago

    Broadmeadows, Victoria, Australia CSL Behring Full time

    About the RoleCSL Behring is seeking a skilled Process Engineer to join the Utilities Department at our Broadmeadows site. As a key member of the team, you will be responsible for providing a reliable source of Utilities to Manufacturing Operations.The successful candidate will report to the Process Engineer Manager and will be responsible for providing...

  • Materials Coordinator

    2 months ago

    Broadmeadows, Australia CSL Behring Full time

    **The Opportunity** CSL Behring has an exciting and unique opportunity for a **Materials Coordinator** **(Engineering/Maintenance)** to join our high performing Engineering Services Stores team at our Broadmeadows site. Reporting to the **Engineering Stores Supervisor**, you will assist in the storage and issue of Engineering materials, including...

  • Senior Specialist – External Supplier Quality

    3 weeks ago

    Broadmeadows, Australia 3085 Seqirus Pty Full time

    Your RoleYou will play a pivotal role in ensuring the quality and compliance of materials and services provided by Suppliers, Service Providers, Third Party Laboratories, 3PLs, Distribution Business Partners and Contract Manufacturers.You’ll develop, implement and maintain robust supplier quality management processes to meet regulatory requirements and...

  • Process Engineer

    2 days ago

    Broadmeadows, Australia 3075 CSL Behring (AU) Pty Ltd Full time

    Your RoleCSL Behring is looking for a Process Engineer to join the Utilities Department at our Broadmeadows site. Your primary role as part of the Utilities Department is to provide a reliable source of Utilities [available and cGMP quality compliant] to Manufacturing Operations.Reporting to the Process Engineer Manager, you will provide professional...

  • Head, R&D Quality

    3 months ago

    Broadmeadows, Australia 2012 CSL Behring L.L.C. Full time

    Job Title: Head, R&D QualityJob Location: King of PrussiaNumber of Positions/Incumbents: 1Job Family Group: QualityJob Family: Quality > Quality Multi DisciplineBusiness/Functional Unit: CSL Behring/R&D QualityFLSA Status (US only): ExemptDate: 06/2024Level: 11Job PurposeState the high-level impact and most important job aspects. The purpose should be...

  • Manager - Requalification

    3 months ago

    Broadmeadows, Australia CSL Behring Full time

    **Your role** The Manager - Engineering Requalification is responsible for managing all aspects of the review and requalification activities across the CSL Broadmeadows site to ensure quality and regulatory requirements are met. Reporting to the Senior Director (Manufacturing and Utilities) you will lead a team responsible for the implementation of Global...

  • CQV Engineer

    1 week ago

    Broadmeadows, Australia Evolve Scientific Full time

    About the role: Based in the northern suburbs of Melbourne, this CQV Engineer will be employed for a period of 6 months within one of Evolve Scientific’s largest pharmaceuticals clients. This engineer will be working alongside the process engineering team and will be responsible for managing ancillary equipment supporting a new syringe filling line to be...

  • E&I Maintenance Engineer

    1 month ago

    Broadmeadows, Australia 3075 CSL Behring (AU) Pty Ltd Full time

    The OpportunityThere is an opportunity for an experienced Electrical & Instrumentation Maintenance Engineer- Afternoon shift (14:30 ~ 23:00) to become part of the E&I team at Broadmeadows.Reporting to the Senior Manager E&I, you will support the Filling & Packing manufacturing value stream whilst also being the E&I supervisor for the site outside of normal...

  • Engineering Data Specialist

    23 hours ago

    Broadmeadows, Victoria, Australia CSL Full time

    About the RoleCSL Behring is a world-class manufacturer of blood plasma proteins used to treat human immune deficiencies and severe autoimmune diseases.We are seeking an Engineering Data Support professional to join our Engineering group as a custodian of Engineering data on SAP. This is a permanent full-time position with hybrid, flexible work...

  • Engineering Data Support

    3 months ago

    Broadmeadows, Australia CSL Full time

    Your Role CSL Behring is a world class manufacturer of blood plasma proteins which are used to treat human immune deficiencies and severe autoimmune diseases. As our organisation continues to grow, we have a position available within our Engineering group as an Engineering Data Support who is a custodian of Engineering data on SAP. This is a permanent...

  • Production Engineer – Bulk Manufacturing

    3 months ago

    Broadmeadows, Australia CSL Full time

    Production Engineer – Bulk Manufacturing Your Role CSL are hiring a Production Engineer to support Bulk Manufacturing. You’ll conduct and coordinate Engineering activities in the designated manufacturing area to ensure department objectives of Safety, Quality, Delivery and Cost are achieved. The main focus of this role will be to directly support...

  • Marketing Executive

    4 months ago

    Broadmeadows, Australia Australian Institute of Engineering Full time

    **About Us**: AIE is a leading educational institution in engineering, offering a broad range of courses from pre-apprenticeship qualifications to post-graduate diplomas. We specialize in disciplines such as Marine Craft Construction, Fabrication, Mechanical, Robotics, and Mechatronics. Our commitment to industry relevance and excellence in education is...

  • CQV Engineer

    4 days ago

    Broadmeadows, Victoria, Australia Evolve Scientific Full time

    About the Role:This CQV Engineer will be employed by Evolve Scientific for a period of 6 months to support a pharmaceutical client in the northern suburbs of Melbourne. The engineer will work alongside the process engineering team to manage ancillary equipment supporting a new syringe filling line.Main Responsibilities:Supporting and delivering project...

  • Engineering Data Support Specialist

    1 week ago

    Broadmeadows, Victoria, Australia CSL Full time

    About the RoleCSL Behring is a world-class manufacturer of blood plasma proteins used to treat human immune deficiencies and severe autoimmune diseases.We are seeking a highly skilled Engineering Data Support Specialist to join our Engineering group as a custodian of Engineering data on SAP. This is a permanent full-time position with hybrid, flexible work...

  • Engineering Data Support Specialist

    3 days ago

    Broadmeadows, Victoria, Australia CSL Full time

    About the RoleCSL Behring is a world-class manufacturer of blood plasma proteins used to treat human immune deficiencies and severe autoimmune diseases.We are seeking a highly skilled Engineering Data Support Specialist to join our Engineering group as a custodian of Engineering data on SAP. This is a permanent full-time position with hybrid, flexible work...

  • Production Engineer

    23 hours ago

    Broadmeadows, Victoria, Australia CSL Full time

    Production Engineer - Bulk ManufacturingAbout the RoleCSL is seeking a highly skilled Production Engineer to support our Bulk Manufacturing team. As a key member of our engineering team, you will be responsible for conducting and coordinating engineering activities in the designated manufacturing area to ensure department objectives of Safety, Quality,...

  • Production Engineer

    4 days ago

    Broadmeadows, Victoria, Australia CSL Full time

    Job SummaryCSL is seeking a highly skilled Production Engineer to support our Bulk Manufacturing department. As a key member of our team, you will be responsible for conducting and coordinating engineering activities to ensure the department's objectives of Safety, Quality, Delivery, and Cost are achieved.Key ResponsibilitiesDevelop and provide equipment...

  • CQV Engineer

    1 week ago

    Broadmeadows, Victoria, Australia Evolve Scientific Full time

    About the Role:This CQV Engineer position is an exciting opportunity to join Evolve Scientific's team as a Pharmaceutical Project Specialist. Based in the northern suburbs of Melbourne, you will be employed for a period of 6 months within one of our largest pharmaceutical clients. As a key member of the process engineering team, you will be responsible for...