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.

This position will support work at the Champlain site in Whitby. Due to the active ingredient in the products manufactured and packaged, employees must have no known allergy to peanuts, tree nuts and birch/oak pollen in order to work safely at the site.

How will you make an impact?

Provide specialized validation knowledge and information, directly needed to support capital projects, operations, and clients. Lead and manage Commissioning, Qualification and Validation (CQV) for large capital projects. Develop validation protocols and reports related to the validation of equipment, facility, utilities, and embedded computer systems for oral solid dose (OSD) manufacturing and Packaging equipment. Ensure documents conform to all Thermo Fisher Scientific Standard Operating Procedures (SOPs), client requirements and Good Manufacturing Practices (GMPs).

What will you do?

• Lead CQV scope of work for large capital projects as follows:

• Lead a team of CQV engineers throughout the project lifecycle.
• Identify appropriate commissioning and qualification strategy and maintain the CQV schedule.
• Track and report progress of CQV throughout the project lifecycle.
• Ensure equipment readiness for CQV phase following construction and installation.
• Change control creation, tracking and closure.
• Manage CQV scope of vendors including technical documentation and execution.
• Host reoccurring meetings with key stakeholders to organize and review daily activities.
• Manage open issues during commissioning and qualification and facilitate resolution.
• Coordinate facility and equipment release process with internal stake holders.
• Develop and execute Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ) validation protocols for complex equipment, facilities, utilities and computer systems and writes reports.
• Review/verify data and performs statistical analysis.
• Monitor the production schedule and coordinate validation activities as required.
• Assess and contribute to change controls from a validation standpoint, determines impact to validated state of equipment and generates actions as needed.
• Investigate validation related deviations and work with key stakeholders from engineering, production/packaging, maintenance, automation, and quality to identify and implement any corrective actions.
• Provide technical/validation expertise and support to Quality Operations/Business or Project management/operations/Pharmaceutics and Process Technology (PPT).
• Complete Validation Project Plan (VPP) and Validation Final Reports (VFR) for large projects.
• Develop and track Key Performance Indicators/metrics for validation program.
• Propose and drive Practical Process Improvement (PPI) efforts related to validation.
• Train on and update Standard Operating Procedures (SOPs) and Master Validation Plans (MPVs), as needed.
• Document review of peer protocols and reports.
• Support regulatory and client audits from an equipment validation standpoint.
• Attend client meetings as equipment validation representative.
• Maintain a safe working environment and reports potential hazards.
• May be essential to perform alternating or rotating shifts (as required).

How will you get here?

Education:

BSc in Chemistry, Engineering, or related field.

Engineering technician certification an asset.

Experience:

Minimum 5 years of experience in validation within the cGMP environment.

Previous experience with equipment or computer systems validation is an asset.

Previous technical writing experience.

Previous experience in statistical analysis an asset.

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 technical 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. Strong judgment, decision making and trouble shooting skills. Demonstrated computer proficiency with Microsoft Office programs. Proficiency with the English language.

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

Job Category

Operations

Thermo Fisher Scientific

is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.