Validation Engineering Specialist II

Work Schedule

7 1/2 hr shift

Environmental Conditions

Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Office, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.)

Job Description

Our Whitby Site specializes in commercial manufacturing for a full range of conventional dosage forms with specialized capabilities, and houses a fully integrated pharmaceutical development services (PDS) facility.

Discover Impactful Work:
Join our collaborative team as a Validation Engineer II at Thermo Fisher Scientific within the Continuous Process Verification (CPV) team, where you'll contribute to global healthcare and scientific advancement. In this role, you'll be responsible for providing specialized validation knowledge and information, which is directly required to support operations and clients. This role main focus will be on Continuous Process Verification (CPV). Compile data and scan of executed batch records, completes risk assessments, protocols and reports related to the validation of manufacturing processes, packaging processes and reviews all finished reports prior to final approval.

Day in the Life:

- Responsible for technical expertise and support to operations/Process Pharmacy.

- Compiles, reviews/verifies and analyzes data

- Prepares and executes process/package validation protocols (new and existing clients) and writing reports.

- Monitors the production scheduling and coordinating validation activities/requirements

- Attends selected client meetings as validation representative (as required)

- Assists in execution of investigations and special studies related to CPV process improvements

- Supports special projects and other validation teams (as required)

- May be essential to perform alternating or rotating shifts (as required)

Keys to Success:

• Bachelor's degree plus 2 years of validation experience in GMP/regulated environment
• Preferred Fields of Study: Engineering, Life Sciences, Chemistry, or related technical field
• Comprehensive knowledge of cGMP, FDA regulations, and industry standards (ISO, GAMP5)
• Strong technical writing skills for validation documentation
• Proficiency in risk assessment and gap analysis
• Experience managing validation projects independently
• Strong data analysis and problem-solving capabilities
• Clear verbal and written communication skills
• Proficient in Microsoft Office applications

• Proficiency preferred in Minitab, Discoverant, JMP

• Proficiency preferred in PowerBi, Microsoft Fabric and A.I
• Experience with automation systems and computer system validation preferred
• Effective interpersonal skills for team collaboration
• Ability to manage multiple projects
• Experience with quality management systems and documentation
• Knowledge of statistical analysis and process control methods
• Consistent record of completing projects on schedule in a deadline-oriented environment

Excellent Benefits

·         Benefits & Total Rewards | Thermo Fisher Scientific

·         Medical, Dental, & Vision benefits-effective Day 1

·         Paid Time Off & Designated Paid Holidays

·         Retirement Savings Plan

·         Tuition Reimbursement

OTHER

·         Relocation assistance is NOT provided

·         Must be legally authorized to work in Canada now or in the future, without sponsorship

·         Must be able to pass a comprehensive background check

Compensation

The estimated annualized pay range for this position in Ontario is $56,400.00–$84,600.00.