Job Details

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:

• SCADA Systems, Process Control Systems (PCS), Environmental Monitoring Automation Systems

• (utilizing Allen Bradley FactoryTalk platform), Author and execute key project documentation, System Impact Assessments, Functional Risk Assessments

• Qualification Project Plans

• Data Migration Plans (as applicable)

• Test Plans (as applicable)

• Requirements Traceability Matrix

• Design Qualification (DQ) development and execution

• 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.