Automation Engineer
$160k - $270kShoolin Inc
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)
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