Project Background
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.
Requirements
* Degree in engineering (automation, robotics, computer science, etc.) or equivalent.
* Minimum 5 years of work experience in GMP manufacturing, with expertise in automation.
* A broad understanding of pharmaceutical manufacturing processes and regulatory environments is essential. Experience in the pharmaceutical industry is advantageous.
* Proficiency in automation solutions (Siemens, Omron, Mitsubishi, etc.). Knowledge of industry standards (GAMP, ANSI/ISA, 21 CFR Part 11, Annex 11) and GxP/QA. Familiarity with ANSI/ISA-99, 100 standards is a plus.
* Strong problem-solving and analytical skills, with experience in data analysis.
* Ability to work in a team-based culture, engaging with internal and external stakeholders.
* Collaborate with Global Automation to implement best practices.
* Contribute to the innovation roadmap and strategic planning. Mentor and train team members to enhance site expertise.
* High communication skills and analytical abilities.
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