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At Pfizer, we believe that every role contributes to our mission of improving patients' lives. Whether you are involved in the design and development of manufacturing processes for products or supporting the upkeep of systems, engineering is crucial to ensuring customers and patients receive the medicines they need. By collaborating with our forward-thinking engineering team, you'll play a pivotal role in accelerating the delivery of medicines to the world.
Job Responsibility:
Support the operation and troubleshooting of manufacturing equipment and control systems including DeltaV DCS, SCADA & PLCs
Support reliability engineering for production and support equipment
Provide on the floor operational support as needed
Responsible for Periodic review of the Automation Systems with support of validation team
Responsibility for managing regulatory aspects of the site networked engineering data collection, monitoring and SCADA systems
Responsible for implementation of compliance initiatives including monitoring of system security procedures and practices and system logins for compliance
Generate user requirement specifications for control systems
Author and/or review design documents for projects and process changes
Define requirements for vendor design documentation
Support FAT/commissioning/qualification activities as required
Review qualification protocols of automated systems
Support the execution of the qualification of automated control systems
Prepare risk assessments for automated systems
Prepare Change Controls associated with changes to control systems
Design and implementation support for functional and process changes, either smaller projects, remediation activities or capital projects
Support future capital projects and assure site automation standards are followed
Assist other departments in evaluating historical process/equipment data
Provide automation guidance and training to other functional groups (i.e. Operations, Validation, Maintenance, etc.)
Responsible for backup/archiving/restoring of Automation configuration and batch
Understand 21 CFR Part 11, cGAMP, and other regulatory guidance associated with computer / automation-based systems
Develop and implement site automation standards for hardware and software
Develop automation Standard Operating Procedures
System Admin for all site Control Systems and Data Historian for adding and disabling user access to Site Automation system
Maintain Manufacturing level network, control level networks and Process I/O network
Requirements:
Bachelor of Technology/Engineering in Electronics/Instrumentation Engineering
8+ experience in a combination of process control, automation (PLC, SCADA & DCS) in pharmaceuticals, biotechnology or other life sciences industries
Capable of reading and understanding electrical control system diagrams (control panel wiring diagrams, loop drawings, panel layout drawings and schedules, etc.)
Good technical knowledge on field Instrumentation
Good technical knowledge of industrial communication networks and related hardware & software
Basic understanding of sequel servers and databases
Familiarity with current industry practices and guidelines including those required / outlined by the FDA, ISO, EU and ICH
Nice to have:
Relevant pharmaceutical experience
Understanding of programming and proficiency in at least one language