Validation Associate

CSL Limited; City of Melbourne; On-site; AUD 54,000 - 72,000; Part time

Job summary

CSL Seqirus is seeking a part-time Validation Associate to support qualification and re-qualification activities for equipment, processes, cleaning, facilities and utilities at our Tullamarine site, with occasional cross-site work in other facilities. You will primarily support the flu cell culture area and coordinate validation deliverables with the Validation manager and stakeholders.

The role requires a cGMP background, a science or engineering degree, and strong written and verbal

Qualifications

• Bachelor's degree is required in engineering, technical or science related field.
• Good understanding of QMS and Risk Management.
• Time management skills for the execution and planning of work.
• Good communication skills both written and verbal, with excellent technical writing skills.

Responsibilities

• Document and complete validation tasks in support of projects and routine requalification.
• Own validation deliverables as directed by the Validation manager and execute as required.
• Develop strong working relationships with stake holders across the site.
• Analyse information and regulatory standards to problem solve using logic and judgement to identify appropriate complaint solutions.
• Complete deviations as required.

Skills

cGMP background

Biopharma experience

Bachelor's degree

QMS & Risk Mgmt

Time management

Written & verbal comms

Team oriented

Education

Bachelor's degree in engineering/technical/science

Job description

CSL Seqirus is a global leader in influenza prevention and pandemic preparedness. We are seeking a part-time (3 days per week) Validation Associate to provide initial qualification/requalification support for equipment, process, cleaning, facility, utilities, transport, computer systems at our state-of-the-art manufacturing facility in Tullamarine.

The Validation Associate will provide initial qualification (including determining requirements for qualification), re-evaluation and re-qualification support for the design, start-up, commissioning and qualification of equipment (including associated computer systems, facilities, process validation, cleaning validation, equipment qualification, transport and utilities) and processes.

This position will primarily work across our flu cell culture area at Seqirus. You could also support work in the Products of National Significance (PNS) facility in Tullamarine and at our Woodend site, although primarily, you will be working based at and working at Tullamarine.

Responsibilities

• Document and complete validation tasks in support of projects and routine requalification.
• Own validation deliverables as directed by the Validation manager and execute as required.
• Develop strong working relationships with stake holders across the site.
• Analyse information and regulatory standards to problem solve using logic and judgement to identify appropriate complaint solutions.
• Complete deviations as required,

Skills and experience

• cGMP background in Biological or Pharmaceutical Industry.
• Experience in Biological or Pharmaceutical Industry.
• Bachelor's degree is required in engineering, technical or science related field.
• Good understanding of QMS and Risk Management.
• Time management skills for the execution and planning of work.
• Good communication skills both written and verbal, with excellent technical writing skills.
• Ability to multitask and work cross functionally and to work within a team environment and independently.

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.

Watch our 'On the Front Line' video to learn more about CSL Seqirus