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 ASTM3500 will be considered a significant advantage, as it underpins risk‑based approaches to design, qualification, and commissioning in compliance with industry best practices.
Key Responsibilities:
Configure, troubleshoot, and commission automation systems including (utilizing Allen Bradley FactoryTalk 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
Qualifications: Bachelor’s degree in Engineering, Computer Science, or related field
Minimum 8 years of experience in pharmaceutical automation engineering
Proficiency with Allen‑Bradley FactoryTalk 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
Seniority Level
Mid‑Senior level
Employment Type
Contract
Job Function
Manufacturing
Industries
Pharmaceutical Manufacturing
Location and Salary
San Francisco, CA $160,000.00–$270,000.00 (Posted 3 days ago)
