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Validation Engineering Specialist I
4 months ago
Provide specialized validation knowledge and information, which is directly required to support operations and clients. Complete all protocols related to the validation of equipment, processes and new products and review all finished reports prior to final approval. Ensure documents conform to all Patheon Standard Operating Procedures (SOPs), client requirements and Good Manufacturing Practices.
What will you do:- 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, and reports, additional studies, rationales to support TRO operations.
- Perform equipment lifecycle review, mapping studies and other periodic activities.
- Support/manage compliance of Deviation Reports (DRs) and Corrective Action Preventative Actions (CAPAs) for the Equipment Engineering department.
- Attend project meetings.
- Follow good documentation practices for document creation, storage and archival.
- Maintain a safe working environment and report potential hazards.
- Flexible to work extended hours or off-shifts based on project expectations (as required).
Education: Minimum post-secondary diploma in Engineering, Science, or related field. Engineering Degree is an asset.
Experience: Minimum 1 year experience in commissioning and qualification within pharmaceutical/biotechnological industry.
Equivalency: Equivalent combinations of education, training, and relevant work experience may be considered.
Knowledge, Skills, and Abilities:Strong written and oral skills. Detail oriented and organized, with a high degree of accuracy and thoroughness. Excellent interpersonal skills, communication, and organizational skills. Strong judgment, decision making and trouble shooting skills.
Ability to multi-task, meeting tight deadlines in a fast-paced environment. Mini-T and data analysis knowledge an asset. Demonstrated computer proficiency with Microsoft Office programs. Proficiency with the English Language.
Standards and Expectations:- Follow all Environmental Health & Safety Policies and Procedures.
- Work collaboratively with fellow team members, modeling 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).
- Maintain workspace in a clean and orderly fashion.
- Effectively engage in and adhere to departmental systems to maintain a smooth and efficient workflow (visual management, scheduling systems, etc.).
- Be client and patient conscious at all times.
- 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.
- Proactively identify areas for improvement in the execution of procedures.
- Communicate risks to timelines in a proactive manner.
- Consistently strive to improve skills and knowledge in related fields.
Position requires ordinary ambulatory skills and physical coordination sufficient to move about lab/lab office locations; ability to stand, walk, stoop, kneel, crouch periodically for prolonged periods of time; manipulation (lift, carry, move) of light to medium weights of 10-35 pounds; arm, hand and finger dexterity, including ability to grasp and type for prolonged periods of time; visual acuity to use a keyboard, computer monitor, operate equipment, and read materials for prolonged periods of time; ability to sit, reach with hands and arms, talk, and hear for prolonged periods of time. Safety glasses, safety shoes, lab coat, latex or similar gloves, safety apron, organic respirator occasionally.
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