Process Validation Engineer (Pharma)

le contenu du travail

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