Principal PAT Specialist / SME – Pharmaceutical Manufacturing
Nice to have's
Job description
About the Position
We are seeking a Principal Process Analytical Technology (PAT) Specialist / SME to support the discovery, evaluation, and implementation readiness of PAT initiatives within a regulated pharmaceutical manufacturing environment.
This is a hands-on SME role combining deep PAT and manufacturing process expertise with requirements definition, technology evaluation, vendor engagement, and implementation planning. The individual will work across Manufacturing, Quality, Regulatory, Engineering, R&D, Digital/IT teams, Product Owners, and implementation partners to ensure PAT solutions are fit for purpose, GMP-ready, scalable, and aligned with manufacturing priorities.
Responsibilities
- Lead structured discovery workshops with manufacturing and technical SMEs to identify and define PAT use cases, business value, scope, and success criteria.
- Translate manufacturing and process needs into clear business, functional, process, data, integration, validation, and system requirements.
- Evaluate PAT technologies and solutions based on technical fit, feasibility, integration requirements, scalability, and compliance considerations.
- Support vendor evaluation, technical discussions, solution assessment, and selection.
- Obtain vendor inputs and estimates to support cost modeling, ROI analysis, and business-case development for prioritized PAT opportunities.
- Develop and maintain PAT implementation plans incorporating GMP, validation, data integrity, quality, and regulatory requirements.
- Partner with Manufacturing, Quality, Engineering, Regulatory, R&D, and Digital/IT stakeholders to establish implementation responsibilities and readiness.
- Support implementation partners with requirements clarification, issue/risk resolution, and milestone execution.
- Support PAT solutions through pilot, implementation, and scale-up readiness.
- Provide SME guidance on PAT technology selection, validation strategy, manufacturing integration, and regulatory/GMP considerations.
Requirements
- Significant hands-on experience with Process Analytical Technology (PAT) in pharmaceutical, biotechnology, or regulated life-sciences manufacturing.
- Demonstrated experience implementing PAT solutions, including technology assessment/selection and implementation readiness.
- Strong understanding of pharmaceutical manufacturing processes and interactions across Manufacturing, Quality, Engineering, Regulatory, and Digital/IT.
- Experience defining requirements for PAT, process monitoring, analytical instrumentation, or related manufacturing technologies.
- Strong understanding of GMP, data integrity, validation/CSV, and regulated computerized systems.
- Experience working with vendors and technical implementation partners.
- Strong requirements documentation, workshop facilitation, stakeholder management, and communication skills.
- Ability to communicate technical PAT concepts effectively to both technical and business stakeholders.
Nice to Have
- Experience with real-time or in-line/at-line process monitoring and manufacturing process analytics.
- Experience assessing PAT use cases and progressing them from discovery through implementation.
- Experience developing business cases, cost models, or ROI assessments for manufacturing technology initiatives.
- Experience supporting manufacturing-site pilots and subsequent scale-up.
- Experience collaborating across manufacturing, process development/R&D, Quality, Regulatory, Engineering, and Digital/IT organizations.
Compensation
- CAD 90,000 to CAD 130,000 + COLA and this position is also eligible for Cognizant’s discretionary annual incentive program, based on performance and subject to the terms of Cognizant’s applicable plans.
We Offer
- Medical/Dental/Vision/Life Insurance
- Paid holidays plus Paid Time Off
- 401(k) plan and contributions
- Long-term/Short-term Disability
- Paid Parental Leave
- Employee Stock Purchase Plan
About the Company
Cognizant is one of the world's leading professional services companies, transforming clients' business, operating, and technology models for the digital era. Our unique industry-based, consultative approach helps clients envision, build, and run more innovative and efficient businesses. Headquartered in the U.S., Cognizant, a member of the NASDAQ-100, is ranked 195 on the Fortune 500 and is consistently listed among the most admired companies in the world. Learn how Cognizant helps clients lead with digital at www.cognizant.com.
Things to know before you apply
- Work authorization: Cognizant will only consider applicants for this position who are legally authorized to work in Canada without requiring employer sponsorship, now or at any time in the future.
- Accommodations: If you have a disability that requires reasonable accommodation to search for a job opening or submit an application, please email [email protected] with your request and contact information.
- AI in hiring: We use artificial intelligence (AI) tools to help us screen and assess applications more efficiently. Our team performs additional human review and ultimately decides who moves forward in our hiring process.
- Open position: Unless otherwise stated, this job posting is for an open position on our team.
- Language proficiency: We ask that all candidates have basic English proficiency for company-wide communications purposes. For roles based in Quebec, professional English proficiency is required, as you’ll deliver services to and collaborate with stakeholders outside the province who may not speak French.
- Inclusion: Cognizant is an equal opportunity employer. Your application and candidacy will not be considered based on race, color, sex, religion, creed, sexual orientation, gender identity, national origin, disability, genetic information, pregnancy, veteran status or any other characteristic protected by federal, provincial or local laws.
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