Process Validation Engineer (Pharma)

仕事内容

As Process Validation Engineer you are responsible to lead, support and participate to qualification and validation for new equipment to be installed in Pilot R&D area including Engineering, Maintenance & Validation tasks in compliance with Corporate and local legal requirements to support the production of Stability batches to be used in Regulatory submission file.

You have following responsibilities

• Guarantee a state-of-the art facility in order to successfully pass various audits (QA, EHS, Corporate, etc …)
• Independently plan, execute and direct commissioning, qualification and validation activities related to new equipment
• Write appropriate documentation (protocols, reports, calibration and maintenance plan) in compliance with global and local requirements and procedures
• Provide statistical relevant approach and data analysis to support validation within design space and associated risk analysis approach
• Provide guidance for equipment validation
• Execute validation with support of technician/operator
• Compile reports and analysis in written and graphic form, describing observations and results
• Directs the completion of complex projects or programs within boundaries of quality, time and budget
• Lead and execute validation project on a cross functional basis. Using broad knowledge and experience in cross-functional activities, coordinate and direct activities of teams and individual contributors
• Maximize the work and effectiveness of internal and external technical resources
• Communicate adequately with other support services (IT, EHS, Facility Services, QA, Finances…)
• Follow & improve Site Maintenance Master Plan to include new equipment needs. Create new equipment documentation such as Operating Procedure covering user procedure and maintenance plan definition

Qualifications

• You have a Master Degree in relevant discipline
• At least 3 years of relevant work experience
• Understanding of R&D environment, engineering and qualification-validation environment
• Excellent knowledge of Quality Systems, GMP and GDPs requirements
• Good project management skills
• Demonstrated team working skills and excellent interpersonal skills
• Stress resistant, dynamic and results driven
• Analytical mindset, sense of details
• Fluent in French and English

Additional Information

• Competitive salary and benefit packages
• Training opportunities