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Validation Engineering Specialist III

2 months ago


Mississauga, Ontario, Canada Thermo Fisher Scientific Full time
Job Summary

We are seeking a highly skilled Validation Engineering Specialist III to join our team at Thermo Fisher Scientific. As a key member of our validation team, you will be responsible for providing specialized validation knowledge and information to support operations and clients.

Key Responsibilities
  • Provide leadership to junior validation engineers by supporting problem-solving and solution generation on projects, training/mentoring, and supporting project progression.
  • Prepare and execute process validation protocols and reports.
  • Review documents from team members and provide guidance on validation requirements.
  • Lead complex URS, FS, DS, HS, FAT, SAT document generation, review, and approval.
  • Develop and lead project timelines, resources, and budgets for both minor and major projects.
  • Review and approve vendor documentation, change controls, and maintenance reports.
  • Lead risk assessment, HAZOP, FMEA's, and validation plans for equipment, systems, and facilities for unique processes and equipment procured in processing, packaging, and PPT areas.
  • Attend client meetings as a validation representative (as required).
  • Update assigned Master Validation Plans (MVPs) as per validation policy.
  • Act as a Subject Matter Expert during audit and regulatory inspections, leading audit responses and assessments.
  • Lead technical investigations, deviations, and Corrective Action Preventative Action (CAPA) implementation.
  • Lead with a continuous improvement attitude and actively participate in and initiate practical process improvement initiatives.
  • Support special projects (as required).
  • Maintain a safe working environment and report potential hazards.
Requirements
  • Postsecondary diploma in Engineering, Science, or a related field. An Engineering Degree is an asset.
  • Minimum 5 years of experience in validation within the pharmaceutical industry. Previous experience in project management is required.
  • Equivalent combinations of education, training, and relevant work experience may be considered.
Knowledge, Skills, and Abilities
  • Strong written and oral communication 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.
  • Proficiency with Microsoft Office programs and Project Management tools.
  • 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 Thermo Fisher Scientific quality systems Standard Operating Procedures (SOPs) and Good Manufacturing Practice (GMP).
  • Maintain a workspace in a clean and orderly fashion.
  • Effectively engage in and adhere to departmental systems to maintain a smooth and efficient workflow.
  • 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 engaging in problem-solving.
  • Model positive thinking and be 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.
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.