Manufacturing System Engineer - Testing Machine System Owner
Amgen
August 16, 2026
On-site
New Albany, OH
Operations
Manufacturing System Engineer - Testing Machine System Owner
Key Responsibilities:
- Serve as Automation System Owner for quality-critical testing equipment, ensuring reliable operation and regulatory compliance.
- Design, develop, and maintain automation and control strategies for accurate, compliant, consistent test operations.
- Implement/configure/optimize PLCs, HMIs, and other automation components to support performance and data integrity.
- Maintain documentation (system design specs, configuration records, validation documentation).
- Lead integration of new automation technologies/instruments to ensure connectivity and data flow.
- Analyze system/test performance data to identify trends, improve reliability, and drive continuous improvement.
- Conduct feasibility studies and cost-benefit analyses for automation upgrades.
- Provide expert technical support for automation issues to coordinate teams and minimize downtime.
- Manage lifecycle activities (upgrades, patching, preventive maintenance) to maintain validated states.
- Lead root cause analysis and corrective actions for deviations.
- Ensure systems align with FDA, GMP, and internal quality standards; support inspections/audits and regulatory submissions.
- Collaborate across sites; lead/support automation projects from concept through implementation.
- Develop and deliver training for engineering/maintenance/operations; mentor team members.
Basic Qualifications:
- Master’s degree; or
- Bachelor’s + 2 years automation experience in Pharma/Medical Devices/Biotech; or
- Associate’s + 6 years; or
- High school/GED + 8 years.
Preferred Qualifications:
- Advanced degree in Mechatronics/CS/Electrical/Mechanical/Chemical.
- Pharma/biotech process knowledge (final drug product operations).
- Data integrity and security; programming/design/installation/validation/lifecycle mgmt of manufacturing process controls.
- Exposure to Machine Vision, Serialization, Robotics, Siemens and Rockwell.
- Ability to interpret/apply GAMPs and GMPs; validation protocol execution and validation process knowledge.
- Organizational/project management, problem-solving, technical writing; strong verbal/written communication.
- Knowledge of Operational Excellence and Lean Transformation.
Application Instructions:
- Apply now via careers.amgen.com.
- Age-identifying information (age, DOB, school dates) may be redacted/removed.
Key Responsibilities:
- Serve as Automation System Owner for quality-critical testing equipment, ensuring reliable operation and regulatory compliance.
- Design, develop, and maintain automation and control strategies for accurate, compliant, consistent test operations.
- Implement/configure/optimize PLCs, HMIs, and other automation components to support performance and data integrity.
- Maintain documentation (system design specs, configuration records, validation documentation).
- Lead integration of new automation technologies/instruments to ensure connectivity and data flow.
- Analyze system/test performance data to identify trends, improve reliability, and drive continuous improvement.
- Conduct feasibility studies and cost-benefit analyses for automation upgrades.
- Provide expert technical support for automation issues to coordinate teams and minimize downtime.
- Manage lifecycle activities (upgrades, patching, preventive maintenance) to maintain validated states.
- Lead root cause analysis and corrective actions for deviations.
- Ensure systems align with FDA, GMP, and internal quality standards; support inspections/audits and regulatory submissions.
- Collaborate across sites; lead/support automation projects from concept through implementation.
- Develop and deliver training for engineering/maintenance/operations; mentor team members.
Basic Qualifications:
- Master’s degree; or
- Bachelor’s + 2 years automation experience in Pharma/Medical Devices/Biotech; or
- Associate’s + 6 years; or
- High school/GED + 8 years.
Preferred Qualifications:
- Advanced degree in Mechatronics/CS/Electrical/Mechanical/Chemical.
- Pharma/biotech process knowledge (final drug product operations).
- Data integrity and security; programming/design/installation/validation/lifecycle mgmt of manufacturing process controls.
- Exposure to Machine Vision, Serialization, Robotics, Siemens and Rockwell.
- Ability to interpret/apply GAMPs and GMPs; validation protocol execution and validation process knowledge.
- Organizational/project management, problem-solving, technical writing; strong verbal/written communication.
- Knowledge of Operational Excellence and Lean Transformation.
Application Instructions:
- Apply now via careers.amgen.com.
- Age-identifying information (age, DOB, school dates) may be redacted/removed.