Job Title

**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 ( a full range of conventional dosage forms ( specialized capabilities, and houses a fully integrated pharmaceutical development services (PDS) facility. **Discover Impactful Work:** The CPV & Data Sciences Leader exists to ensure manufacturing processes remain consistently controlled, compliant, and continuously improving by leveraging data science and digital tools. The role drives the design and execution of Continued Process Verification (CPV) programs while translating complex process data into actionable insights that improve product quality and performance. It also enables the adoption of advanced analytics, dashboards, and AI-driven monitoring to proactively detect risks and optimize operations. Ultimately, the position bridges manufacturing, quality, and digital teams to deliver scalable, data-driven decision-making across the process lifecycle. **Day in the Life:** u2022 Lead the design, implementation, and lifecycle management of Continued Process Verification (CPV) programs across manufacturing processes. u2022 Define and monitor Critical Quality Attributes (CQAs) and Critical Process Parameters (CPPs) using statistical and risk-based methodologies. u2022 Analyze manufacturing and quality data using statistical tools to identify trends, variability, and potential risks impacting process performance. u2022 Develop and maintain dashboards and reports using digital tools (e.g., Discoverant and Power BI) to enable real-time process monitoring and decision-making. u2022 Oversee data collection, integration, and trending from manufacturing systems such as Manufacturing Execution Systems (MES), Laboratory Information Management Systems (LIMS), and data historians. u2022 Support investigations related to deviations, Out-of-Specification (OOS) results, and process trends by performing root cause analysis and providing data-driven insights. u2022 Collaborate with Manufacturing Science and Technology (MSAT), Quality, Engineering, Automation, and Information Technology (IT) teams to align CPV strategies with site and global objectives. u2022 Act as the site Subject Matter Expert (SME) for Discoverant, including system configuration, user support, troubleshooting, and continuous improvement. u2022 Implement and support advanced analytics, including artificial intelligence (AI) and machine learning (ML) models, to enhance process monitoring and predictive capabilities. u2022 Translate complex datasets into clear, actionable insights and documentation to support regulatory submissions, audits, and inspections. u2022 Define and track key performance indicators (KPIs) to ensure ongoing process control, compliance, and continuous improvement. u2022 Mentor and provide technical guidance to team members in CPV, data analytics, and digital tools. u2022 Drive adoption of digital manufacturing solutions and promote a culture of data-driven decision-making across the organization. u2022 Ensure all activities comply with Good Manufacturing Practices (GMP), data integrity principles, and internal quality systems. **Key to Success:** **Education:** u2022 Minimum Bacheloru2019s degree in engineering, Data Science, Statistics, Pharmaceutical Sciences, or a related field u2022 Training or certification in data analytics, statistical analysis, or data science tools (e.g., Python, Minitab, Discoverant, JMP, PowerBI, or SAS) u2022 Knowledge of regulatory guidelines and frameworks (e.g., Food and Drug Administration (FDA), European Medicines Agency (EMA), and International Council for Harmonisation (ICH)) u2022 Familiarity or certification in Good Manufacturing Practices (GMP) and data integrity principles (e.g., ALCOA+) **Experience:** u2022 Minimum of 3 years of experience in pharmaceutical manufacturing, Manufacturing Science and Technology (MSAT), process validation, or data analytics within a Good Manufacturing Practices (GMP) environment u2022 Experience applying Continued Process Verification (CPV) principles in support of process monitoring and lifecycle validation u2022 Experience performing statistical analysis and using data science tools (e.g., Python, R, JMP, or SAS) in manufacturing or quality settings u2022 Experience working with manufacturing data systems such as Manufacturing Execution Systems (MES), Laboratory Information Management Systems (LIMS), or data historians u2022 Experience supporting investigations (e.g., deviations or Out-of-Specification (OOS) results) using datadriven approaches, including internships or co-op placements in relevant industries **Equivalency** **_:_** u2022 Equivalent combinations of education, training, and relevant work experience may be considered **Knowledge, Skills, and Abilities:** u2022 Strong knowledge of Continued Process Verification (CPV), process validation lifecycle, and regulatory expectations (e.g., Food and Drug Administration (FDA), European Medicines Agency (EMA), and International Council for Harmonisation (ICH)) u2022 Expertise in statistical analysis, data science methodologies, and multivariate analysis techniques u2022 Proficiency with data analytics and visualization tools (e.g., Python, R, JMP, SAS, Discoverant, and Power BI) u2022 Understanding of manufacturing data systems, including Manufacturing Execution Systems (MES) and Laboratory Information Management Systems (LIMS) u2022 Knowledge of data integration and data modeling u2022 Strong analytical and problem-solving skills with the ability to interpret complex datasets and identify root causes u2022 Ability to translate technical data into clear, actionable insights for cross-functional stakeholders u2022 Strong leadership, collaboration, and influencing skills in a cross-functional environment u2022 Ability to manage multiple priorities and drive projects in a fast-paced, regulated environment u2022 Commitment to Good Manufacturing Practices (GMP) and data integrity principles (e.g., ALCOA+) u2022 Ability to support continuous improvement initiatives and drive digital transformation and innovation u2022 Detail oriented and organized, with a high degree of accuracy and thoroughness. u2022 Good/Excellent organizational skills and ability to prioritize in a face-pace environment. u2022 Demonstrated computer proficiency with Microsoft Office programs. u2022 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. Use of Personal Protective equipment may be required and may include any of the following: Safety glasses, safety shoes, lab coat, latex or similar gloves, safety apron, organic respirator occasionally. **Excellent Benefits** Benefits & Total Rewards | Thermo Fisher Scientific ( 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 $69,400.00u2013$104,050.00. 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.