Job Description

Why Patients Need You

Technology impacts everything we do. Pfizer\xe2\x80\x99s digital and \xe2\x80\x98data first\xe2\x80\x99 strategy focuses on implementing impactful and innovative technology solutions across all functions from research to manufacturing. Whether you are digitizing drug discovery and development, identifying solutions, or making our work easier and faster, you will be making a difference to countless lives.

What You Will Achieve

The Digital Manufacturing Team is responsible for the delivery of Pfizer\xe2\x80\x99s Core Digital Manufacturing Operations Management (MoM) capabilities at every level of the Pfizer Global Supply (PGS) Plant Network (ISA 95 Levels 0-4). These solutions are critical to Manufacturing & Lab Execution, Manufacturing Process Intelligence and Production Optimization that aim to improve product quality, increase asset utilization/uptime, automate manual workflows, and streamline plant floor operations. The Digital Manufacturing vision is to \xe2\x80\x9cSimplify processes and experiences to drive PGS outcomes\xe2\x80\x9d.

The Manufacturing 4.0 (M4.0) Team supports all of Pfizer\xe2\x80\x99s Core Manufacturing & Engineering Solutions, while enabling a secure, seamless flow of contextualized data from the device & control levels, all the way to the top of the Enterprise. Our goal is to create persona driven, connected experiences across our shop floors to predict and optimize operations, while providing real-time insights to operators. Come join us to create Pfizer\xe2\x80\x99s Factory of the Future!

The Manager, Validation and Testing will be responsible for ensuring the Digital Manufacturing 4.0 agile teams are compliant with the Pfizer Agile Software Delivery lifecycle and will implement the lifecycle and change management processes. The candidate will formulate and execute on the testing/validation strategy including the manual and test automation for the solutions. The candidate will contribute to the creation of a standardized approach to validation and test automation across the Digital Manufacturing 4.0 teams.

How You Will Achieve It

• Ensure full adherence to Agile framework and the Software Development Lifecycle Management working closely with the Product owners, Scrum Masters and Development team
• Co-own and conduct the Solution Risk profile assessments, Electronic Record and Electronic Signature (ERES), Data Integrity and Supplier Control Assessments for the M4.0 solutions.
• Create and maintain testing/ verification strategy for the M4.0 applications.
• Manage execution of Functional Testing, Database Verification Testing, Performance Testing, UAT Testing etc., to ensure the solution meets business needs.
• Manage the testing defects triage process and track defects to closure.
• Develop and implement the test automation framework using the Pfizer preferred testing tools
• Execute the Release Management Process to ensure compliant release of applications to production.
• Partner with and support the Business Users during the User Acceptance Testing and obtain business sign off for Release
• Create the software quality deliverables such as user requirements, test protocols, testing traceability matrix and test summary report
• Facilitate and execute on the software change management process for the deployment of the applications into different Environments.
• Support Disaster Recovery Planning & Testing
• Support AC&D (Acquisitions, Collaborations & Divestitures)
• Support Inspection Readiness and Regulatory Board(s) Audits, as required

Qualifications

Must-Have

• Education: Bachelor\xe2\x80\x99s Degree
• 5+ years of relevant experience
• Experience with Agile Software Delivery
• Strong process and procedure skills, most particularly regarding System Development Lifecycle and functional enhancement governance
• Ability to work across multiple concurrent activities and successfully adapt to changing priorities as required.
• Must have strong analytical skills, excellent verbal, and written communication skills, be detail-oriented, self-directed, and a team player.
• Strong experience in MS Office Products (i.e. MS Word, Excel, PowerPoint, Access)

Nice-to-Have

• Experience leading GxP compliance for large scale solutions (e.g. Manufacturing or Engineering Solutions) in a Pharmaceutical company
• Thorough understanding of 21 CFR Part 11
• Experience in the use of test management and test automation tools
• Experience with Agile Software Delivery and/or Scrum Master Certification a plus.
• Experience with Agile Software Delivery and/or Scrum Master Certification
• Knowledge of the pharmaceutical industry, preferably Commercial or sales and marketing

Work Location Assignment: Flexible

Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.

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