Senior Validation Specialist

With unrivaled expertise in immunology, and operating sites in North America (East and West Coast) and Europe, Nexelis is a leading provider of assay development and advanced laboratory testing services in the infectious diseases, metabolic diseases, and oncology fields. Our versatile team of scientists, working with our advanced technology platforms, were instrumental in the development, qualification, validation, and large-scale sample testing of assays that supported the FDA filing of almost 100 new molecular entities, including blockbuster vaccines, anti-viral drugs, and immunotherapy, gene and cell therapy products.

We are currently looking for a motivated candidate with experience to fill the The Senior Validation Specialist role and provide validation expertise to implement, modify, decommission regulated equipment and computerized systems at the Laval Nexelis site while ensuring compliance with internal procedures and industry best practices (21-CRF Part11, GAMP5, NIST, GCLP, GLP, etc.).

Your main responsibilities:

• Write/Review/Approve validation deliverables (VP, URS, FS, RA, DS, UTCR, IQ/OQ/PQ, TM, VR, etc.) and ensure qualification execution according to business priorities and internal procedures.
• Lead multiple validation projects and coordinate their timely delivery with key stakeholders and external collaborators (team members, validation consultants, QA, IT, scientists, vendors)
• Ensure laboratory equipment and software life cycle management is carried out according to business strategy and internal procedures.
• Maintain regulated system access & train laboratory personnel in their operation with established procedures. Provide ad-hoc expert support on certain computerized systems.
• Diagnose hardware/software issues & devise solutions in close collaboration with scientific personnel and vendors.
• Administrate the facility & laboratory equipment maintenance program (calibration, preventive maintenance, repairs), ensure the timely review of all service reports and the proper remediation of any discrepancies with internal procedures and external vendors.
• Administrate the facility environmental monitoring system.

What we are looking for:

• Bachelor’s degree in life sciences or engineering.
• Minimum 12 years experience working in a regulated pharmaceutical environment.
• Minimum 10 years experience validating computerized systems and laboratory equipment.
• High focus required in order to execute complex interventions autonomously.
• Ability to work methodically with a concern for precision and accuracy.
• Excellent analytical and problem-solving skills
• Proficient with office tools (Project, Visio, Outlook, Excel, Word, Power point)
• Fluently bilingual in English and French (both oral and written)
• Ability to plan, schedule and prioritize to ensure efficient delivery on multiple projects.
• Apply clinical trial, laboratory, and pharmaceutical processes and protocols as well as quality assurance processes and procedures, data storage and retrieval steps.
  
• Applicants must be legally authorized to work in Canada.

What we can offer:

• Generous time off policy starting at three (3) weeks vacation and five (5) days of sick time
• Employee coverage on medical, dental and vision.
• Employee assistance program.
• Health expense account