Equipment and Systems Validation Specialist (Expansion Project) - #448595

The validation specialist participates in the qualification and requalification of equipment and systems at the Candiac site. He or she acts as a validation project coordinator and ensures that all the stages of the validation project are followed. He or she coordinates activities of all involved departments as well as acting as a liaison to the internal clients.

The Systems and Equipment Validation Specialist, performs validation services specifically associated, in the short term, with the Pharmascience Sterile Injectable Drug Plant Expansion project. According to the nature of the position and the project, daily on-site presence is essential. Some flexibility for working from home will be granted.

Responsibilities & Tasks

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
• executes periodic requalifications
  
  

Experience And Requirements For The Position

• Bachelor’s degree in engineering and/or sciences
• This is mainly an office job, with executions in the production & QC departments (sterile plant, laboratories, mechanical rooms). Working outside of regular office hours is sometimes required.
• Minimum 1 years of experience in production equipment and in critical systems (HVAC, purified water, compressed air)
• minimum 1 years in the pharmaceutical industry.
• capacity to write all documents required for Validation Life Cycle: Risk Assessments, validation plans, qualification protocols and summary reports.
• knowledge of automated and computerized systems an asset (ex: BAS, PLC/HMIs).
• in-depth knowledge of cGMPs and regulatory requirements for system and equipment validation.
  
  

Skills, Knowledge And Abilities

• Excellent technical writing skills
• Excellent technical writing skills Fluency in English and French (oral and written); the incumbent will be required to write and read documentation in the second language (Health Canada & FDA)
• Good problem-solving skills
• Excellent communication skills
• Proficiency in Microsoft office software
• Knowledge of SAP, Trackwise and other electronic document management systems an asset.
• Dynamic and autonomous
• Ability to manage several projects simultaneously