Job Description

We are looking for a Validation Expert for our site in Kurtköy who is passionate about quality and process excellence. In this role, you will play a key part in ensuring robust process, cleaning, and packaging validation across the full lifecycle, from planning to shop‑floor execution. Working closely with cross‑functional teams, you will help maintain GMP compliance, drive ongoing process verification, and ensure inspection readiness through strong technical expertise and high‑quality documentation

Major accountabilities:

• Lead and support site validation planning by authoring and maintaining validation master plans for processes, cleaning, and packaging, including ongoing verification.
• Ensure a robust validation lifecycle by maintaining a state of control through Ongoing Process Verification (OPV) and identifying critical variables for routine monitoring and quality risk management.
• Author, review, and approve validation and verification protocols and reports (process, cleaning, and packaging).
• Support and oversee execution of validation activities on the shop floor.
• Review Master Batch Records and related change controls, assessing revalidation requirements based on technical changes.
• Conduct and support pre‑validation risk assessments, providing technical expertise and applying risk management tools in a cross‑functional environment.
• Manage validation deviations, define corrective and preventive actions, and ensure inspection readiness in compliance with cGMP and Novartis standards.

Minimum Requirements:

• Bachelor’s degree (BSc) in Chemistry, Pharmacy, Chemical Engineering, Pharmaceutical Technology, or related field.
• 2–3 years of experience in pharmaceutical manufacturing, MS&T, technical development, or quality.
• Good understanding of manufacturing processes, process equipment, and GMP quality systems.
• Experience with process validation and writing/reviewing technical reports.
• Fluent in English and proficient in the local site language.

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Why Novartis?

Our purpose is to reimagine medicine to improve and extend people’s lives and our vision is to become the most valued and trusted medicines company in the world. How can we achieve this? With our people. It is our associates that drive us each day to reach our ambitions. Be a part of this mission and join us! Learn more here: https://www.novartis.com/about/strategy/people-and-culture

Benefits and Rewards:

Read our handbook to learn about all the ways we’ll help you thrive personally and professionally: Novartis Life Handbook

Commitment to Diversity & Inclusion:

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

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: https://talentnetwork.novartis.com/network

Skills Desired

Applied Statistics, Assembly Language, Change Control, Chemical Engineering, Continual Improvement Process, Cost Reduction, Data Analytics, Electronic Components, General Hse Knowledge , Including Gdp, Knowledge Of Capa, Knowledge Of Gmp, Lean Manufacturing, Manufacturing Process, Manufacturing Production, Manufacturing Technologies, Process and Cleaning Validation, Process Control, Process Simulation, Risk Management, Root Cause Analysis (RCA), Scientific Method, Six Sigma, Statistical Analysis, Technology Transfer