07 Aug
|
Health and Aged Care Professionals
|
City of Moonee Valley
07 Aug
Health and Aged Care Professionals
City of Moonee Valley
Health and Aged Care Professionals – Airport West VIC
Casual/Temporary
22d ago , from Health and Aged Care Professionals
An outstanding opportunity exists for an experienced Validation Specialist to join a leading pharmaceutical manufacturing organisation. This senior technical role is ideal for someone who enjoys solving complex analytical challenges, driving continuous improvement and influencing best practice across quality and laboratory operations.Working within the Analytical Science & Technology team, you will provide subject matter expertise in analytical method validation, development, troubleshooting and lifecycle management while supporting cross‑functional projects and regulatory compliance.
About the Role:
As the Senior Validation Specialist, you will play a key role in ensuring analytical methods remain robust, compliant and fit for purpose throughout their lifecycle.
You will:
- Lead analytical method validation, development and optimisation activities
- Provide technical expertise for troubleshooting complex laboratory testing issues
- Drive method standardisation and robustness programs
- Lead analytical method transfers across manufacturing sites
- Support regulatory submissions, inspections and audits
- Design and manage experimental studies involving new analytical technologies
- Review validation data and identify trends, deviations and improvement opportunities
- Influence continuous improvement initiatives across Quality Control operations
- Collaborate closely with Quality, Manufacturing, Technical Development and cross‑functional stakeholders
An outstanding opportunity exists for an experienced Validation Specialist to join a leading pharmaceutical manufacturing organisation. This senior technical role is ideal for someone who enjoys solving complex analytical challenges, driving continuous improvement and influencing best practice across quality and laboratory operations.Working within the Analytical Science & Technology team, you will provide subject matter expertise in analytical method validation, development, troubleshooting and lifecycle management while supporting cross‑functional projects and regulatory compliance.
About the Role:
As the Senior Validation Specialist, you will play a key role in ensuring analytical methods remain robust, compliant and fit for purpose throughout their lifecycle.
You will:
- Lead analytical method validation, development and optimisation activities
- Provide technical expertise for troubleshooting complex laboratory testing issues
- Drive method standardisation and robustness programs
- Lead analytical method transfers across manufacturing sites
- Support regulatory submissions, inspections and audits
- Design and manage experimental studies involving new analytical technologies
- Review validation data and identify trends,
deviations and improvement opportunities
- Influence continuous improvement initiatives across Quality Control operations
- Collaborate closely with Quality, Manufacturing, Technical Development and cross‑functional stakeholders
To be successful, you will bring:
- Bachelor's Degree in Science or a related discipline
- Experience within pharmaceutical, biopharmaceutical or other highly regulated manufacturing environments
- Strong understanding of cGMP and Quality Control laboratory operations
- Experience in analytical method validation and/or analytical method development
- Knowledge of CAPA, Change Control and quality systems
- Strong troubleshooting and root cause analysis capability
- Excellent written and verbal communication skills
- Ability to manage multiple technical projects and influence stakeholders
What's on Offer
- Opportunity to work with advanced analytical technologies
- Senior technical specialist position with broad organisational influence
- Collaborative, science‑driven culture
- Diverse project work across validation, method development and continuous improvement
Why Apply?
This is an excellent prospect for an experienced validation professional looking to step into a highly visible technical leadership role where your expertise will directly influence product quality, laboratory innovation and continuous improvement.If you're passionate about analytical science, quality and solving complex technical challenges, we'd love to hear from you.
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📌 Senior Validation Specialist (City of Moonee Valley)
🏢 Health and Aged Care Professionals
📍 City of Moonee Valley