Validation Engineering Specialist II

How will you make an impact :

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 :

• Design validation strategies for process, packaging, or cleaning validation
• Prepare validation protocols and reports for process, packaging, bulk hold studies, shipping studies, cleaning validation and other additional studies
• Monitor and coordinate manufacturing execution and provide trainings on validation protocols
• Perform data collection, statistical analysis and prepare summary reports
• Lead annual monitoring programs for cleaning and manage site cleaning matrix
• Monitor and coordinate swab sampling activities for cleaning validation
• Perform risk assessments for equipment, cleaning procedures and manufacturing processes
• Prepare risk assessment, protocols, and reports for Continued Process Verification program
• Conduct technical discussions 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)

How will you get here :

Education :

Bachelors / Master’s in chemistry, Pharmacy, Engineering, Biotechnology or related field.

Experience :

Minimum 3-year experience in validation, process engineering or quality within the pharmaceutical / biotechnology industry.

1 year experience conducting statistical analysis is an asset

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 :

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).

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 strives to improve skills and knowledge in related field.

Physical Requirements :

• 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.