Validation Engineering

1 month ago

Mississauga Ontario CW, Peel region, Canada Thermo Fisher Scientific Inc. Full time

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Able to lift 40 lbs. without assistance, Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Loud Noises (Equipment/Machinery), Office, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.)

Job Description

Summary:

Provide specialized validation knowledge and information, which is directly required to support operations and clients. Completes all protocols related to the validation of equipment, processes and new products and reviews 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 Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ) protocols for more equipment, facilities, and computer systems.

  • Execute test cases for IQ, OQ, PQ in equipment, facilities, and computer systems qualifications.

  • Prepare and complete process validation protocols (new and existing clients) and writing reports.

  • Maintain documentation room and retain room.

  • Review and verify data.

  • Maintain cleaning program and trending cleaning results.

  • Provide support to Quality Operations/Business or Project management/operations/Pharmaceutics and Process Technology (PPT).

  • Support special projects (as required)

  • 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:

High school diploma/General Educational Development (GED) Certificate is required

Working towards B.Sc. in engineering, pharmacy, chemistry or a related field is preferred.

Experience:

Previous experience in a validation or science related environment.


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 SOPs and Good Manufacturing Practice (GMP). Maintain workspace in a clean and orderly fashion. Actively engage in and adhere to departmental systems in order 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. Models 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.

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