Senior Validation specialist, equipment

1 month ago


Montreal Quebec GF, CA Pharmascience Inc. Full time
Senior Validation Specialist, Equipment & System

Job Category: Engineering

  • Posted: July 22, 2024
  • Full-Time
  • On-site
Locations

Showing 1 location

The Equipment and Systems Validation Specialist participates in the validation of complex equipment/systems at the Royalmount and Dorval site. As a team member, they will also help other validation team members in their projects. They act as a validation project manager and ensure that all stages of the project are followed in accordance with standard procedures (health and safety, Good Manufacturing Practices, etc.). They coordinate activities of all involved parties: professionals, entrepreneurs, consultants, regulatory bodies, as well as acting as a liaison to internal clients. The Equipment and Systems Validation Specialist also reviews and approves the documents (protocols and reports) from the Validation Specialists.

Responsibilities & Duties
  • Write validation protocols – installation, operational and performance qualification and requalification
  • Execute or supervise the execution of the protocol tests
  • Manage the revision and approval of protocols
  • Manage the documentation related to validation activities (filing, update and preparation)
  • Participate in the resolution of deviations and deficiencies
  • Participate in audits as a validation expert
Skills, Knowledge & Abilities
  • Capacity to manage multiple projects simultaneously
  • Capacity to review and approve technical reports efficiently
  • Capacity to write technical reports in a neat and concise manner

Ease in managing pressure and adapting to change. Possess a good sense of communication and urgency (prioritization). Enjoys teamwork and exchanges. Capabilities in software tools such as Microsoft Office, Outlook.

QualificationsEducation

Preferred:

  • Bachelor or better in Chemical Engineering or related field.
  • Bachelor or better in Science or related field.
Experience

Preferred:

  • Project management experience (an asset)
  • In-depth knowledge of the cGMP’s and regulatory requirements for equipment and system validation/qualification (FDA an asset)
  • Knowledgeable in automated and computerized systems qualification
  • Capacity to develop all documents required for 21 CFR part 11 compliance, including URS, validation plans, qualification protocols and summary reports
  • 2 years’ experience in qualifying equipment used in manufacturing and/or packaging of various pharmaceutical forms, as well as critical systems (HVAC, purified water, compressed air)
  • 2 years’ experience in the Pharmaceutical industry
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