Process Validation Expert

Jan 19, 2022

Job Description

Responsible for developing, implementing and managing the site process validation, primary packaging validation, cleaning validation and revalidation strategies to meet cGMP and quality requirements on time and on budget to ensure that programs are compliant with Regulatory Authorities’ expectations and related SOPs. Responsible for equipment qualification and requalification.
Responsible for scale-up and line transfer for RLT products by developing and executing a validation strategy according to cGxP for scale-up and line transfers and alignment with all the sites. Executing and managing process, primary packaging, and cleaning validation activities to meet cGMP requirements on time and quality to ensure that site validation programs are compliant with global regulatory expectations.

Your key responsibilities:
Your responsibilities include, but are not limited to:

• Participate in transfers and launches by aligning on the product validation approach. Provide technical expertise for pre-validation / validation strategy.
• Overall responsibility for establishment, prioritization, execution and tracking of Validation Master Plan for process, cleaning, packaging validation and ongoing process verification (OPV).
• Ensure manufacturing and cleaning processes are validated; overview on site state of validation is maintained by monitoring also validation KPIs.
• Establish local procedures & templates for respective validation documentation.
• Ensure that all Site validation activities are performed and are in line with the current AAA (or applicable) Novartis requirements and cGMP, handling any deviations associated to these activities including oversight of pre-validation and validation resulting from technical changes.

Diversity & Inclusion / EEO

Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.

Minimum Requirements

What you’ll bring to the role:

Ideal background:

• Education: BSc. in Chemistry, Pharmacy, Chemical Engineering or Pharmaceutical Technology.
• Languages: Fluency in English and in Italian

Experience / Professional requirements:

• Thorough understanding of manufacturing processes and related process equipment
• At least 2 years’ experience in pharma companies, executing process validation, having led and managed validation projects, including sterile manufacturing
• Expert in reviewing and writing technical reports.

Work location: Colleretto Giacosa (TO)

Why Advanced Accelerator Applications (AAA)?
Thousands of people die of cancer around the world every day. At Advanced Accelerator Applications (AAA), a Novartis company, our mission is to transform lives through radioligand therapy in nuclear medicine to fight several leading types of cancer. How will we continue to be on the cutting edge of medicine? We believe new groundbreaking solutions can be found at the intersection of medical science and digital innovation. That a diverse, equitable and inclusive environment inspires new ways of working. We believe our potential can thrive and grow in an unbossed culture underpinned by integrity, curiosity and flexibility. And we can reinvent what's possible, when we collaborate with courage to aggressively and ambitiously tackle the world’s toughest medical challenges. Because the greatest risk in life, is the risk of never trying! Imagine what you could do here at Novartis!

Imagine what you could do at Novartis!

Join our Novartis Network: If this role is not suitable to your experience or career goals but you wish to stay connected to learn more about Novartis and our career opportunities, join the Novartis Network here:
Colleretto Giacosa
Technical Operations
Full Time
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Process Validation Expert

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