Validation Engineering Specialist II
Thermo Fisher Scientific
Whitby, Canada
6d ago

As part of the Thermo Fisher Scientific team, you’ll discover meaningful work that makes a positive impact on a global scale.

Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner and safer.

We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the world’s toughest challenges, like protecting the environment, making sure our food is safe or helping find cures for cancer.

How will you make an impact?

You will provide specialized validation knowledge and information, which is directly needed to support operations and clients.

You will complete protocols and reports related to the validation of manufacturing processes, packaging processes (including serialization), equipment qualification, cleaning and Continuous Process Verification(CPV).

You will ensure documents conform to all Thermo Fisher Standard Operating Procedures (SOPs), client requirements and Good Manufacturing Practices.

What will you do?

Essential Functions :

  • Prepares and executes validation protocols (new and existing clients) and writing reports.
  • Prepares Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ) for more complex equipment, facilities and computer systems.
  • Reviews / verifies data and performs statistical analysis.
  • Monitors the production scheduling and coordination of validation activities as required
  • Provides technical / validation expertise and support to Quality Operations / Business or Project management / operations / Pharmaceutics and Process Technology (PPT).
  • Document review of peer protocols and reports.
  • Maintain Master Validation Master Plans and validation SOPs up to date.
  • Maintains cleaning program and trending cleaning results.
  • Performs 5 years qualification reviews.
  • Supports equipment swabbing.
  • Attends client meetings as validation representative (as required)
  • Supports special projects (as required)
  • May be essential to perform alternating or rotating shifts (as required)
  • How will you get here?

    Education :

    BSc in Chemistry, Engineering, or related field.

    Experience :

    Minimum 3 years experience in validation within the pharmaceutical industry.

    Previous experience in statistical analysis preferable.

    Equivalency :

    Equivalent combinations of education, training, and relevant work experience may be considered.

    Knowledge, Skills and Abilities :

  • Ability to work well independently and in a team based environment.
  • Good computer skills (Microsoft Word and Excel).
  • Good writing skills as well strong accuracy and attention to detail.
  • Excellent interpersonal skills, communication and organizational skills.
  • Ability to multi-task, meeting tight deadlines in a fast paced environment. Proficiency with the English language.
  • Strong judgment, decision making and trouble shooting skills.
  • Our Mission is to enable our customers to make the world healthier, cleaner and safer. Watch as our colleagues explain 5 reasons to work with us.

    As one global team of 90,000 colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation and support patients in need.

    StartYourStory at Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.

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