Job Description

Why Patients Need YouWhether you are involved in the design and development of manufacturing processes for products or supporting maintenance and reliability, engineering is vital to making sure customers and patients have the medicines they need, when they need them. Working with our innovative engineering team, you\'ll help bring medicines to the world even faster by imagining whats possible and taking action.What You Will AchieveWorking with Pfizers dynamic engineering team, you will play a critical role in the management of manufacturing information systems to improve manufacturing success rates and ensuring zero down time.As a Senior Associate, your knowledge and skills will contribute towards the goals and objectives of the team. Your focus and ability to meet team targets will help in completing critical deliverables. Your innovative use of communication tools and techniques will facilitate in explaining difficult issues and establishing consensus between teams.It is your hard work and dedication that will make Pfizer ready to achieve new milestones and help patients across the globe.How You Will Achieve It

• 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, 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.

QualificationsMust-Have

• Bachelor of Technology/Engineering in Electrical/Electronics/Instrumentation/Communications or equivalent
• 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.

Nice-to-Have

• Master's degree
• Relevant pharmaceutical experience
• Understanding of programming, and proficiency in at least one language

Work Location Assignment: On PremisePfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.Engineering#LI-PFE

Pfizer