Validation Engineer

Position Overview :

The Validation Engineer I will help support the Radiopharmaceutical facility and GMP operations in Indianapolis. The Validation Engineer I will be responsible for the drafting and executing commissioning qualification and validation (CQV) documents and protocols which support the use of highly specialized facility utility analytical and process equipment. The position will utilize a wide range of engineering disciplines to support the advancement from construction to clinical development and subsequent GMP commercial operations. Additional responsibilities may include the onboarding of new technologies process development GMP operations support deviation investigation CAPA management continuous improvement projects and future facility expansion projects.

Key Responsibilities :

• Work with the project team and / or General Contractor as required to support the commissioning and validation of a 60000 sq. ft. office warehouse and GMP Radiopharmaceutical production facility
• Develop and implement the CQV strategies for the GMP spaces including but not limited to office warehouse development quality control sterility / microbiology and GMP production areas
• Work with consultant(s) as required to support the implementation and execution of the CQV program
• Support the engineering QC and Operations team as required to improve and implement new processes
• Provide validation support for day-to-day development and GMP operations
• Provide engineering and operational support as required
• Develop expertise in areas of validation (process validation QC assets CSV cleaning validation etc)
• Apply technical knowledge and abilities to investigate manufacturing deviations
• Review data and documentation to support investigations
• Participate and drive projects and continuous improvement efforts
• Draft GMP documentation including but not limited to SOPs Forms Protocols Technical Documents Reports Deviations CAPAs Change Controls and reports.
• Support Health Authority Inspections
• Maintain department KPIs related to performance
• Provide support executing equipment and process validations as necessary.

Key Skills

Python,SOC,Debugging,C / C++,FDA Regulations,Minitab,Technical Writing,GAMP,OS Kernels,Perl,cGMP,Manufacturing

Employment Type : Full Time

Experience : years

Vacancy : 1