Job type: Full-time

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Job Description

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?

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:

  • Independently lead validation projects across process, packaging, or cleaning validation

  • Lead technical investigations, process improvements and site validation programs

  • Conduct training to support new hires and junior team members

  • Approve batch records, change controls, lab documents for validation projects

  • Prepare validation protocols and reports for process, packaging, bulk hold studies, shipping studies, cleaning validation and other additional studies

  • Review and update Master Validation Plans (MVPs), validation procedures as per validation policy.

  • Provide technical support during client and regulatory audits.

  • Maintain a safe working environment and report potential hazards.

  • Lead and participate in cross-functional risk assessments for equipment, cleaning procedures and manufacturing processes

  • Conduct technical discussions with clients, project managers and other stakeholders to drive validation activities.

  • 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 5 years’ experience in validation process engineering or quality within the pharmaceutical/ biotechnological industry.

1 year experience conducting statistical analysis or project management 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-T and data analysis knowledge an asset.
  • Demonstrated computer proficiency with Microsoft Office programs. Proficiency with the English Language.


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.

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 100,000 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.

Apply today! http://jobs.thermofisher.com

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Deadline: 09-07-2024

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