The Validation Specialist, Process Equipment, participates in the qualification of equipment and systems associated with the sterile product manufacturing line. 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. The Validation Specialist, Process Equipment, performs validation services specifically associated, in the short term, with Pharmascience's 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.

Responsabilities & Duties :

• write protocols (installation, operation and performance qualification)
• perform or supervise tests required by qualification protocols
• manages documentation relating to validation activities (filing, updating and preparation of files)
• manages protocol revisions and approvals

participates in the resolution of validation deviations

writes technical notes

perform periodic requalifications

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 skills

Excellent communication skills

Proficiency in Microsoft Office software

Knowledge of SAP, Trackwise and other electronic documentation management systems an asset

Dynamic and autonomous

Ability to manage several projects simultaneously

Ability to develop all required validation documents (validation plans, qualification protocols and summary reports).

Knowledge of automated and computerized systems qualification (e.g. SCADAs, PLCs, HMIs).

In-depth knowledge of GMPs and regulatory requirements for validation / qualification of sterile product production equipment and systems.