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.
Requirements
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
Ready to shape the future of life sciences?
Benefits
Remote work options
Additional Information
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 .
Lonza · Hyderabad, IN