Associate Manager - MSAT
Bioksha
Remote
As a Process Engineer , you will be part of Tech Operations team and play a crucial role in improving patients' lives while working at Pfizer. Your contributions will directly impact the development and delivery of innovative solutions that enhance the quality of life for patients worldwide. Join us in our mission to bring breakthroughs that change patients' lives.
What You Will Achieve
In this role, you will work as Process Engineer with hands-on experience inDelta DCS systems, PI Historian to support the development and qualification of automation logic, Historian integrations in compliance with21 CFR Part 11andthe latest validation standards.
The role involves supporting design documents and developing qualification protocols, as well as configuring recipes, formulas, and controlling logic in Delta V DCS system, Historian systems along with Qualifications.
Key Responsibilities
- Creation of DCS Recipe parameters, Formulas and developing process flows as per Tech transfer inputs.
- Review and interpretSoftware Design Specifications (SDS),Functional Specifications (FS), and related documents to understand automation requirements.
- Prepare comprehensiveQualification Documentsincluding - Design Qualification (DQ), Installation Qualification (IQ), Operational Qualification (OQ),Performance Qualification (PQ)
- Ensure documentation aligns with21 CFR Part 11,GAMP 5, and internal validation SOPs.
- Develop and configureDeltaV DCSlogic, including Batch Recipes, Control Modules, Equipment Modules, Formulas and Phases
- Maintain traceability matrices and ensure audit readiness of all documentation.
- Qualification of Historian systems.
- Understanding batch recipes,formulas, andcontrol strategies.
- Solid understanding of21 CFR Part 11,GAMP 5, andCSVprinciples.
- Strong documentation and technical writing skills.
- Familiarity withdata integrityandaudit trailrequirements.
- Knowledge ofISA-88batch control standards.
- Knowledge of ALCOA Principles.
- PI System Architecture Knowledge of PI Data Archive, Asset Framework (AF), Event Frames, and PI Vision.
- Interface Configuration Experience with OPC, Modbus, and other industrial protocols
- Data Modeling & Contextualization Building AF templates and event frames for batch and equipment tracking
- System Integration Connecting PI with MES, ERP & SCADA systems
- Reporting Tools Using PI Datalink, PI Vision, and PI Rt Reports for analytics and compliance reporting.
- Bachelor’s degree inElectrical and Electronics, Automation,Chemical or related engineering discipline.
- Minimum10 years of experiencein automation engineering within a regulated industry (pharma/biotech preferred).
- Strong working knowledge ofDeltaV DCS systems.
- Expertise on 7016 – Delta Batch Implementationor equivalent hands-on experience.
- Experience using common AI tools, including generative technologies such as ChatGPT or Microsoft Copilot, to support problem solving and enhance productivity. Demonstrated curiosity for exploring how these tools can improve outcomes and understanding of responsible AI practices, includingrisk management and ethical use
Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.
To learn more about acceptable and prohibited uses of AI during the recruitment process, please review our candidate AI-use guidelines available onPfizer Careers.
Engineering