Automation Engineer

We are seeking a highly skilled Pharmaceutical Automation Engineer to support automation and qualification activities for critical systems in a regulated pharmaceutical environment with our San Francisco Bay Area pharmaceutical client. The ideal candidate will have hands‑on experience with automation platforms and a deep understanding of compliance and quality standards. A fundamental understanding of ASTM
3500 will be considered a significant advantage, as it underpins risk‑based approaches to design, qualification, and commissioning in compliance with industry best practices.

• Configure, troubleshoot, and commission automation systems including (utilizing Allen Bradley Factory Talk platform)
• Author and execute key project documentation, System Impact Assessments, Functional Risk Assessments
• Create Requirements Traceability Matrix
• Develop and execute Design Qualification (DQ) documents
• Ensure compliance with the client’s Pharmaceutical Quality System and regulatory requirements
• Develop and maintain Quality Risk Management (QRM) deliverables
• Collaborate with cross‑functional teams to ensure successful automation integration and qualification

• Bachelor’s degree in Engineering, Computer Science, or related field
• Minimum 8 years of experience in pharmaceutical automation engineering
• Proficiency with Allen‑Bradley Factory Talk and related automation platforms
• Strong knowledge of GMP, Pharmaceutical Quality Systems, and regulatory compliance
• Experience developing and executing qualification documentation and QRM deliverables
• Excellent analytical, documentation, and communication skills

Mid‑Senior level

Contract

Manufacturing

Pharmaceutical Manufacturing

San Francisco, CA $–$ (Posted 3 days ago)