Validation Engineering Specialist I - thermofisher

Work Schedule

Environmental Conditions

Job Description

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.

Essential Functions:  Prepare validation protocols and reports for process, packaging, or cleaning validation  Monitor and coordinate manufacturing execution and provide trainings on validation protocols  Perform data collection, statistical analysis and prepare summary reports  Monitor and coordinate swab sampling activities for cleaning validation  Prepare risk assessment, protocols and reports for Continued Process Verification program  Prepare protocols and reports for bulk hold studies, shipping studies and other additional studies as and when required  Interact with clients, project managers and other stakeholders to drive validation activities.  Maintain a safe working environment and report potential hazards.  Flexible to work extended hours or off-shifts based on project expectations (as required)

REQUIRED QUALIFICATIONS

Education:

Minimum post-secondary diploma in Chemistry, Engineering, Science or related field. BSc in Chemistry or Engineering is an asset.

Experience:

Minimum 1 year experience in validation, process engineering or quality within the pharmaceutical/ biotechnological industry. Previous experience in statistical analysis preferred.

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-Tab and data analysis knowledge an asset. Demonstrated computer proficiency with Microsoft Office programs. Proficiency with the English Language.

Standards and Expectations: