3 to 5 years technical experience in pharmaceutical manufacturing
Bachelor's, master's or ph.d. degree in technical field
Working knowledge of cgmp guidelines and regulatory requirements
The role involves supporting or leading new product introductions by conducting process comparisons, development studies, and validating cleaning processes
Job Summary
The role involves supporting or leading new product introductions by conducting process comparisons, development studies, and validating cleaning processes.
Candidates must demonstrate strength in technical writing for PPQ protocols, reports, and CMC sections while ensuring compliance with regulatory requirements.
The position requires providing technical expertise for deviations, root cause analysis, and participating in Continued Process Verification activities.
Matching Summary
The role involves supporting or leading new product introductions by conducting process comparisons, development studies, and validating cleaning processes.
Skills & Requirements
Must-have
3 to 5 years technical experience in pharmaceutical manufacturing
Bachelor's, Master's or Ph.D. degree in technical field
Working knowledge of cGMP Guidelines and regulatory requirements
Experience with process optimization and continuous improvement
Knowledge of Quality by Design (QbD) principles
Nice-to-have
Strong technical writing skills for change requests and reports
Ability to lead small-scale experiments and simulations
Collaboration across global company S&T network
Proactive identification of solutions for production issues
Leadership behaviors aligned with company standards
Key Requirements
Bachelors, Masters or Ph.D. degree in Chemical Engineering, Mechanical Engineering, Chemistry, Biological sciences or Pharmaceutical Sciences
3 to 5 years technical experience in pharmaceutical manufacturing industry
Valid driving license not explicitly required but flexible work arrangements noted