Associate Manager – Automation & Instrumentation

Use Your Power for Purpose

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.

Automation Engineer will have responsibility for managing regulatory aspects of the process automation and control systems used in the manufacture of sterile injectable. This position will provide engineering and technical support related to the operation, maintenance, installation, startup/commissioning, testing, and qualification of manufacturing equipment and systems within a sterile injectable manufacturing facility.

What You Will Achieve

In this role, you will:

• 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
• Support all investigations and audits as needed pertaining to automation subject matter.
• 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.
• Review vendor automation design documentation (FS, HDS, SDS, DDS, requirements traceability matrix, code and logic, etc.).
• 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, QA, 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

Here Is What You Need (Minimum Requirements)

• Bachelor of Technology/Engineering in Electronics/Instrumentation Engineering
• 6 to 8 years’ experience in a combination of process control, automation (PLC, SCADA & DCS) in pharmaceuticals, biotechnology or other life sciences industries.
• Individual must be capable of reading and understanding electrical control system diagrams (control panel wiring diagrams, loop drawings, panel layout drawings and schedules, etc.). Comfortable walking down control system diagrams and red lining them to reflect as built conditions.
• 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.

Bonus Points If You Have (Preferred Requirements)

• Relevant pharmaceutical experience
• Understanding of programming and proficiency in at least one language
• Knowledge of Good Manufacturing Practices (GMP)
• Ability to train others effectively
• Strong problem-solving skills

Work Location Assignment: On Premise

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

Engineering