Equipment and Systems Validation Specialist – Aseptic Filling – Pharmascience

Title of the Job: Equipment and Systems Validation Specialist – Aseptic Filling

Location: Candiac, QC

Job Description: Description :The validation specialist, Aseptic Filling, participates in the qualification of systems and equipment associated with the sterile product filling line 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, Aseptic Filling, performs validation services specifically associated, in the short term, with the Pharmascience Sterile Injectable Drug Plant Expansion project.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
• executes periodic requalifications (including sterilization and depyrogenation cycles)

Skills, Knowledge & Abilities :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 skillsExcellent communication skillsProficiency in Microsoft Office softwareKnowledge of SAP, Trackwise and other electronic documentation management systems an assetDynamic and autonomousAbility to manage several projects simultaneouslyExperience with aseptic filling isolators an asset.Ability to develop all required validation documents (validation plans, qualification protocols and summary reports).Experience with the qualification of automated and computerized systems (e.g. SCADAs, PLC, HMIs).Education : Bachelor
BachelorExperience : 5 years: Experience in the qualification of systems and equipment used in the manufacture of sterile products.

Company Name: Pharmascience

Salary:

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