Quality Engineering, QA Specialist, Project Delivery (CQ & CSV)

Lonza

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IN - Hyderabad Onsite Quality Assurance

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About this role

Quality Engineering, QA Specialist – Project Delivery (CQ & CSV)

Location: Hyderabad, India

The actual location of this job is in Hyderabad, India. Relocation assistance is available for eligible candidates and their families, if needed.

Join our global team to oversee the qualification and validation compliance of cutting-edge equipment and computerized systems powering cGMP pharmaceutical manufacturing. In this role, you will safeguard our global quality standards while driving compliance and operational consistency across critical CAPEX projects.

Office‑first roles This is an office‑first role. Working together in person supports close, real‑time collaboration and team alignment, enabling us to deliver our best work. You will work primarily in the office, with the flexibility to work remotely for 20% of your time (one day per week).

What you will get:

An agile career and dynamic working culture.
An inclusive and ethical workplace.
Compensation programs that recognize high performance.
A variety of benefits dependent on role and location.
The full list of our global benefits can be found here: https://www.lonza.com/careers/benefits.

What you will do:

Ensure Technical Compliance: Review and approve commissioning, qualification, and validation protocols and reports to ensure equipment and computerized systems meet global regulatory requirements.
Provide Regulatory Guidance: Act as a quality guide for project teams, offering first-level oversight on complex cGMP and global regulatory expectations (such as FDA and Swissmedic).
Collaborate Across Functions: Partner with Global Engineering Leads, Regional QA Teams, and Project Delivery members to harmonize commissioning and qualification standards across CAPEX growth projects.
Support Quality Reviews: Actively participate in Project Quality Reviews (PQRs) and internal audits across diverse project teams to ensure compliance consistency.
Uphold Data Integrity: Evaluate, identify, and improve existing processes to rigorously protect and uphold Lonza’s core data integrity principles.
Drive Continuous Improvement: Translate evolving regulatory trends, internal audit findings, and inspection outcomes into actionable quality improvements.
Manage Critical Documentation: Review risk assessments, technical documentation, and regulatory responses to maintain strong corporate inspection readiness.

What we are looking for:

Experience: Strong background in commissioning, qualification, validation (CQ & CSV), and compliance within a regulated pharmaceutical or cGMP manufacturing environment.
Technical Skills: Solid technical understanding of qualification processes for both equipment and complex computerized systems, including associated risk management.
Education: A degree background centered around a Bachelor’s or Master’s degree in Engineering (Biologics or Chemical) or the Biological Sciences.
Communication & Collaboration: Excellent communication and stakeholder management skills, with a proven ability to confidently represent QA expectations within cross-functional project teams.
Language Proficiency: Business fluent in written and spoken English.
Core Attributes: Strong analytical and proactive problem-solving skills, capable of performing a variety of routine work within established policies under general supervisor instruction.

About Lonza

At Lonza, our people are our greatest strength. With 30+ sites across five continents, our globally connected teams work together every day to manufacture the medicines of tomorrow. Our core values of Collaboration, Accountability, Excellence, Passion and Integrity reflect who we are and how we work together. Everyone’s ideas, big or small, have the potential to improve millions of lives, and that’s the kind of work we want you to be part of.

Innovation thrives when people from all backgrounds bring their unique perspectives to the table. At Lonza, we value diversity and are committed to creating an inclusive environment for all employees. If you’re ready to help turn our customers’ breakthrough ideas into viable therapies, we look forward to welcoming you on board.

Ready to shape the future of life sciences? Apply now.