What You Will Achieve
The Automation Engineer role will play an integral part in supporting automation and validation activities at clinical drug product manufacturing sites and data collection and integration with PGS sites in EU.
The successful candidates will progress DPMs digital and automation strategy by implementing data collection, analysis and automation solutions for manufacturing processes.
Other responsibilities also include support of compliance related activities, including GMP documentation, validation, training, and quality system.
Automation and Technology Support:
o Daily support of systems that are utilized and managed by Drug Product Manufacturing.
o Learn and practice with the systems to develop a front-end and back-end knowledge base. Serve as a technical trainer and assist team members with ideas for improvements and troubleshooting.
o Collaborate with Pfizer Digital for system maintenance, upgrades, and audit activities.
o Contribute to the completion of projects, develop plans for own projects and leads small project teams.
o Generate and develop standard work practices for data collaborations with PGS sites.
o Modify moderately complex logic/scripts that requires a degree of scientific and/or manufacturing process expertise.
o Support Data strategy initiatives related to Manufacturing Systems including data integration initiatives.
o Organize, plan, and drive upgrades, improvements, and audit activities.
o Own and maintain configuration specifications and other technical documentation.
Validation and Change Management:
o Own and maintain configuration specifications and other technical documentation.
o Creation, ownership and execution of validation and change management process deliverables.
Continuous Improvement:
o Own and maintain configuration specifications and other technical documentation.
o Creation, ownership and execution of validation and change management process deliverables.
Professional Skills
o Demonstrate good planning, organizing, time management and team participation skills.
o Clearly communicate progress and issues to peers.
o Manage day to day work to ensure timely completion of activities – drive improvement and performance.
Must have
• BS degree in Engineering, Computer Science or equivalent discipline with 0-2+ years of engineering, automation or relevant experience required
• Demonstrated ability to learn new computerized systems and skills
• Demonstrated experience in a pharmaceutical / medical device setting.
• Technical Writing Experience
• Knowledge of Computerized Systems, Compliance regulations and standards
• Experience with Aveva/PI historians
• Teamwork spirit, good communication skills and training abilities
• Excellent interpersonal effectiveness and communication skills {written and oral}
• Fundamental knowledge of manufacturing operations
• Experience in a GMP manufacturing production environment
• Experience with GMP Validation Lifecycles (Equipment or Software)
Nice-to-have:
• Manufacturing Executions System Experience
• Relevant pharmaceutical experience
• Experience with one or more of the following platforms is a plus: MS SQL, Python, Redshift or Snowflake
• Understanding of programming, and proficiency in at least one language
Standing, bending, climbing, reaching and lifting upward of 55 pounds may be required.
Personal Protective Equipment such as gloves, a full Tyvek suit and breathable air and/or filtering face piece may be required.
Frequent travelling to PGS sites (Freiburg, New Bridge and Ascoli etc.) is required for this role.
Support of off-shift and weekend manufactures when necessary.