Our client is seeking an experienced Validation Lead to play a pivotal role in the expansion of their aseptic fill-finish manufacturing site. With a significant growth programme planned over the next 12 months, this is an opportunity to shape validation strategy, build capability, and lead a high-performing team through an exciting period of transformation.
This role is ideally suited to a validation professional who thrives in fast-paced GMP environments and has experience supporting site start-ups, major expansions, or manufacturing scale-up programmes. Alongside providing technical leadership, you'll be responsible for developing a strong validation function and partnering with Engineering, Quality, Manufacturing, and Global teams to deliver complex projects while maintaining the highest standards of compliance.
Key Responsibilities
- Lead and develop the Validation team, creating a collaborative, high-performing culture.
- Own the Site Validation Master Plan and provide strategic leadership across the full validation lifecycle.
- Drive validation activities supporting site expansion, new equipment, utilities, manufacturing processes and aseptic operations.
- Partner with cross-functional teams to deliver capital projects, new technologies, and product introductions while ensuring GMP compliance.
- Champion risk-based validation, data integrity, continuous improvement, and inspection readiness across the site.
What We're Looking For
Our client is looking for a validation leader who combines strong technical expertise with the ability to inspire teams and successfully deliver change.
Essential Experience
- Degree in Engineering, Life Sciences, Pharmaceutical Sciences, or a related discipline
- Extensive validation experience within GMP pharmaceutical or biopharmaceutical manufacturing.
- Demonstrated success leading validation activities within aseptic or sterile manufacturing environments.
- Experience supporting site start-ups, facility expansions, or significant manufacturing scale-up programmes.
- Proven people leadership experience with the ability to coach, develop, and motivate technical teams.
Why Consider This Opportunity?
This is an opportunity to join a business at a defining stage of its growth journey. You'll have the chance to influence site strategy, lead a talented validation team, and play a key role in delivering a major aseptic manufacturing expansion while helping build a best-in-class validation function for the future.
Note: This is a fully onsite role.
If you are interested in this opportunity, or if you would like to find out more, reach out to Kellie O'Donovan today on 021 2300 300
