Senior Quality Automation and CSV Engineer

Responsibilities

• Lead the design, implementation, and validation of automated systems and new technology solutions within a sterile injectable manufacturing environment.
• Develop and execute validation strategies for automated systems, robotics, and AI-based tools in compliance with GAMP 5 and 21 CFR Part 11.
• Author and review critical validation documentation including URS, FS, DS, and IQ/OQ/PQ protocols and reports.
• Oversee system implementation, upgrades, and change control for automation and computer systems.
• Perform risk assessments to ensure data integrity and adherence to cGMP, FDA, and EMA regulatory guidelines.
• Provide independent quality oversight and act as a quality representative during system implementation and qualification phases.
• Identify opportunities to integrate advanced analytics and new technologies for process optimization and digital transformation.

Requirements

• Bachelor's degree in Engineering, Computer Science, Pharmaceutical Sciences, or a related field.
• Minimum of 8 years of experience in pharmaceutical automation and computerized system validation (CSV).
• Expertise in GAMP 5, 21 CFR Part 11, and Annex 11 compliance.
• Strong knowledge of sterile injectable manufacturing processes and aseptic techniques.
• Proficiency in risk-based validation and data integrity principles.
• Advanced knowledge of GMP systems such as Veeva eQMS, LIMS, CDS, or ERPs.

Preferred Qualifications

• Master's degree in Engineering, Computer Science, or Pharmaceutical Sciences.
• Familiarity with SCADA, PLC, MES, and AI platforms.

Benefits

• Annual pay range of $125,000 - $135,000 depending on experience.
• Bonus eligibility.
• Comprehensive benefits package.

About the Company

Tolmar is a pharmaceutical company dedicated to improving patient lives through high-quality products. We operate with core values centered on people, proactive agility, ethical conduct, continuous improvement, and accountability.