Job Title: Automation Engineer – Pharma Industry
Location: California, United States
Job Summary
We are seeking a skilled Automation Engineer to design, develop, implement, and maintain automation systems in a pharmaceutical manufacturing environment. The role ensures compliance with regulatory standards such as GMP, FDA, and data integrity requirements, while improving process efficiency, reliability, and safety.
Key Responsibilities
- Design, develop, and implement automation solutions for pharmaceutical production and packaging processes.
- Maintain and troubleshoot PLC, SCADA, and DCS systems.
- Ensure compliance with Good Manufacturing Practices (GMP) and regulatory standards.
- Support validation activities including IQ, OQ, PQ documentation and execution.
- Collaborate with cross-functional teams (Production, QA, QC, Maintenance).
- Monitor system performance and implement continuous improvement initiatives.
- Manage and update automation documentation, SOPs, and change controls.
- Provide technical support during audits and inspections.
- Ensure data integrity and cybersecurity compliance in automation systems.
Required Qualifications
- Bachelor’s degree in Electrical Engineering, Electronics, Instrumentation, or related field.
- 2–8 years of experience in automation within the pharmaceutical or regulated industry.
- Strong knowledge of PLC (e.g., Siemens, Allen-Bradley), SCADA, and DCS systems.
- Familiarity with 21 CFR Part 11, GMP, and validation processes.
- Experience with HMI design and industrial communication protocols.
Preferred Skills
- Experience in sterile, API, or formulation plants.
- Knowledge of MES (Manufacturing Execution Systems).
- Understanding of Industry 4.0 and digital transformation concepts.
- Strong problem-solving and analytical skills.
- Good communication and documentation abilities.