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Validation Engineer

Alten Proex

This is a Full-time position in Melancthon, ON posted May 11, 2022.

Title: Validation Specialist Location : Alliston, ON Strong in QC analytical instrument validation IQ, OQ, PQ instrumentation validation Method optimization method transfers.

Serving as validation representative for instruments Performing analytical instrument validation Performing any validation change control during the life-cycle of the system ROLE RESPONSIBILITIES Initiates and leads change control for implementation of analytical instruments or changes to existing analytical instrumentation and associated instrument control software where applicable in Quality Control laboratories.

Authors cGMP risk assessments, user requirements & functional specifications, validation plans, protocols (i.E.

IQ, OQ, PQ), reports, addendums and other validation deliverables as required by the site validation SOPs.

Assist the system owner with evaluating and recommending the appropriate user roles and privileges for data integrity (where applicable), writing instrument operation instructions and preventive maintenance plans.

Authors protocol to challenge the main aspects of these requirements during validation to demonstrate adherence.

Initiates and leads risk assessment, gap analysis, and deviation management associated with validation of lab instruments.

Completes periodic reviews of instruments and instrument control software with a focus on change control, deviation investigations, and CAPA to ensure compliance and validated state of the instrument.

Previous experience with PR/CAPA systems preferred.

Reviews validation deliverables created by others for adherence to site validation SOPs and acts as validation approver as needed.

All other duties as assigned.

QUALIFICATIONS Bachelor’s degree in a science or engineering-related discipline with knowledge in quality operations laboratory processes.

2-5 years of experience in the validation of laboratory instruments including those with computerized systems attached in a cGMP environment (required).

2-5 years of experience in the Pharmaceutical industry or relevant business experience within Quality Assurance or Validation cGMP Compliance.

Hands-on experience operating instrument systems.

Demonstrated attention to detail.

Good oral and legible written communication skills.

Must be able to work independently.

Mastery of core computer software/systems (Word, Excel, Sharepoint, etc.).

Demonstrated ability to work in a team environment and manage workload to meet deadlines.

Ability to follow a variety of instructions furnished in written, oral, diagram, or schedule form.