Job Title: Automation Engineer
About the Role:
We are seeking an experienced Automation Engineer to join our team at {company}. As a key member of our operations team, you will play a crucial role in ensuring the optimal performance of our automation systems and driving digital transformation projects.
Key Responsibilities:
* Oversee automation systems to ensure maximum uptime and performance.
* Manage system user access, backups, and restores.
* Implement corrective actions and collaborate with vendor technical support.
* Identify and execute small projects to enhance system performance.
* Contribute to capital planning, project execution, and documentation.
* Ensure all activities comply with site and corporate Quality Systems.
* Create and maintain engineering deliverables and test scripts.
* Develop and implement global automation strategies to standardize processes.
* Maintain and optimize automation systems and infrastructure.
* Develop solutions tailored to the manufacturing environment.
* Drive automation projects, ensuring cost, schedule, and technical goals are met.
* Stay updated with technology trends and benchmarks to keep our client at the forefront.
Requirements:
* Degree in Engineering (Automation, Robotics, Computer Science, or a related field) or equivalent.
* Minimum of 5 years' experience in GMP manufacturing, with a focus on automation.
* Strong understanding of pharmaceutical manufacturing processes and regulatory environments.
* Experience in the pharmaceutical industry is an advantage.
* Proficiency in automation solutions, including Siemens, Omron, and Mitsubishi.
* Knowledge of industry standards such as GAMP, ANSI/ISA, 21 CFR Part 11, Annex 11, and GxP/QA.
* Familiarity with ANSI/ISA-99 and ANSI/ISA-100 standards is a plus.
* Fluent in written and spoken English.
Skills:
* GAMP ISA Annex 11 QA English GMP