Validation Specialist

Vertali APAC Pty Ltd

City of Melbourne

On-site

AUD 90,000 - 130,000

Full time

14 days+

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Benefits offered by this job

Health Insurance

Dental Insurance

Vision Insurance

Life Insurance

Short-Term Disability

Long-Term Disability

FSA

HSA

Mental Health Benefits

Parental Benefits

Adoption Leave

Birth Parent or Maternity Leave

Non-Birth Parent or Paternity Leave

Fertility Benefits

Adoption Assistance Program

Family Support Resources

Work Flexibility

Office Life and Perks

Commuter Benefits Program

Vacation and Time Off

Paid Vacation

Paid Holidays

Personal/Sick Days

Leave of Absence

Volunteer Time Off

Stock Purchase Program

Professional Development

Tuition Reimbursement

Diversity and Inclusion

Job summary

CSL Seqirus seeks a Senior Validation Specialist for its Melbourne manufacturing facility, leading validation deliverables across cool rooms and cleanrooms. You will partner with cross-functional teams to define scope, schedules and resources, execute programs, document activities, and drive process improvements.

The role requires 6+ years in biopharmaceutical manufacturing, cGMP knowledge, and strong leadership and communication skills, with the ability to multitask and travel up to 10%.

Qualifications

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.
Leadership skills supporting team members and leading activities.
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.

Responsibilities

Act as SME supporting Validation Manager to define validation scope, schedules, and resourcing.
Own, manage, and execute validation deliverables and programmes within assigned area.
Document and complete validation activities as directed.
Build strong, candid relationships within Validation and cross-functional teams.
Influence coordinators and managers to align with validation priorities.
Collaborate closely with Manufacturing, QC, Sterility Assurance, MS&T, AS&T, Warehouse, Engineering, Automation, and QA.
Lead analysis and resolution of complex validation issues and major deviation investigations.
Drive validation assessments for departmental and cross-functional deviations.
Identify and lead validation process improvements and key projects.
Support delegation of responsibilities between Validation Specialist and Validation Manager as required.
Travel up to 10% as needed.

Skills

Leadership

Time management

Communication skills

Multitasking

Cross-functional collaboration

Education

Bachelor's degree in engineering/technical/science

Job description

Job Description

The Senior Validation Specialist 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, and utilities) and processes. You will own and manage validation deliverables across the site cool rooms and cleanrooms.

Act as SME supporting Validation Manager to define validation scope, schedules, and resourcing
Own, manage, and execute validation deliverables and programmes within assigned area
Document and complete validation activities as directed
Build strong, candid relationships within Validation and cross-functional teams
Influence coordinators and managers to align with validation priorities
Collaborate closely with Manufacturing, QC, Sterility Assurance, MS&T, AS&T, Warehouse, Engineering, Automation, and QA
Lead analysis and resolution of complex validation issues and major deviation investigations
Drive validation assessments for departmental and cross-functional deviations
Identify and lead validation process improvements and key projects
Support delegation of responsibilities between Validation Specialist and Validation Manager as required
Travel up to 10% as needed

About the Employer

CSL is a leading global biotechnology company with a dynamic portfolio of lifesaving medicines and therapies, CSL Seqirus is a global leader in influenza prevention and pandemic preparedness.

We are seeking a Senior Validation Specialist to join our team at our state of the art, manufacturing facility at 2 Sky Rd, Melbourne Airport VIC 3045., 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.

About the Candidate

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
Leadership skills supporting team members and leading activities
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

This role requires a strong understanding of the process of commissioning, qualification and validation. It is required that this experience is gained through practical experience within a validation function, with evidence of experience across multiple validation competencies. The level of experience required may typically be found through 6+ years of biological or pharmaceutical manufacturing experience, or through equivalent applicable roles. Validation experience within Pharmaceuticals, and demonstrated knowledge of cGMPs, EU and FDA regulatory guidelines, and validation principles required.

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