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.

Key Responsibilities

• 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

Qualifications

• 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

Seniority Level

Mid‑Senior level

Employment Type

Contract

Job Function

Manufacturing

Industries

Pharmaceutical Manufacturing

Location and Salary

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

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