Validation Engineering Specialist I

7 days ago

Mississauga, Ontario, Canada Senseability Full time

ThermoFisher Scientific Validation Engineering Specialist I - Equipment Engineering Mississauga , Ontario Apply Now Provide specialized validation knowledge and information, which is directly required to support operations and clients.

Ensure documents conform to all Patheon Standard Operating Procedures (SOPs), client requirements and Good Manufacturing Practices.
Support equipment commissioning and qualification activities and support project manager.
Prepare validation protocols Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ) protocols for complex equipment, facilities, and systems,
Support/manage compliance of Deviation Reports (DRs) and Corrective Action Preventative Actions (CAPAs) for the Equipment Engineering department.
Attend project meetings.
Flexible to work extended hours or off-shifts based on project expectations (as required).
Minimum post-secondary diploma in Engineering, Science, or related field.
Engineering Degree is an asset.
Minimum 1 year experience in commissioning and qualification within pharmaceutical/biotechnological industry.
Equivalent combinations of education, training, and relevant work experience may be considered.
Mini-T and data analysis knowledge an asset. Demonstrated computer proficiency with Microsoft Office programs. Proficiency with the English Language.
*Follow all Environmental Health & Safety Policies and Procedures. Work collaboratively with fellow team members, modelling positive team principles and partnering to meet project and departmental objectives. Carry out all duties within strict compliance to Patheon quality systems Standard Operating Procedures (SOPs) and Good Manufacturing Practice (GMP). Understand Key Performance Indicators and strive to improve the performance of the team by identifying areas for system improvements and engage in problem solving. Model positive thinking and is open to change, motivating the team to adapt to shifts in priorities and new ways of working. Communicate risks to timelines in a proactive manner. Consistently strives to improve skills and knowledge in related field.

Position requires ordinary ambulatory skills and physical coordination sufficient to move about lab/lab office locations; visual acuity to use a keyboard, computer monitor, operate equipment, and read materials for prolonged periods of time; Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.

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