Job Description

Description :

The Sterilization Validation Specialist participates in the qualification and requalification of equipment and systems. In particular, he or she is involved in the validation of sterilization processes in a GMP pharmaceutical environment, including wet sterilization, dry heat sterilization, depyrogenation and VHP sterilization. He or she acts as a validation project coordinator and ensures that all stages of the validation project are followed. He or she coordinates the activities of all departments involved and acts as liaison with internal customers.

RESPONSABILITIES & DUTIES

• Writes protocols (installation qualification, operation qualification and performance qualification).
• Executes or supervises testing required by qualification protocols
• Manages documentations related to validation activities (filing, updates and file preparation)
• Manages protocol revisions and approvals
• Participates in problem solving for validation deviations
• Participates in follow-ups for change controls related to validated systems and equipment
• Writes & reviews standard operating procedures (sop)
• Works in collaboration with the project engineering team
• Writes technical notes when required
• Evaluates changes on validated systems and equipment
• Support audits when required
• Support visual inspection when required

Skills, Knowledge & Abilities

• Excellent technical writing skills
• Strong interpersonal skills are required.
• Good ability to solve problems
• Excellent communications skills
• Knowledge of SAP, Trackwise and other electronic documentation management systems an asset.
• Dynamic and autonomous
• Ability to manage multiple simultaneous projects
• capacity to write all documents required for 21cfr part 11, validation plans, qualification protocols and summary reports
• knowledge of automated and computerized systems (ex: bas) (an asset)
• in-depth knowledge of cgmps and regulatory requirements for equipment and system validation

Education : Bachelor
Bachelor

Pharmascience