Senior Digital Engineer - PAS-X Expert

Role: Senior Digital Engineer - PAS-X Expert Work location: Gainesville, FL Job Description: As a Senior Digital Engineer you will play a critical role in the design, implementation, and maintenance of our automation systems, specifically using Werum PAS-X. You will lead automation projects, ensuring compliance with industry standards and regulations while optimizing production processes. This role is ideal for an automation expert with a minimum of 10 years of experience in the pharmaceutical industry, who is ready to take on a challenging and rewarding position. Key Responsibilities: • Werum PAS-X Implementation: Lead and manage the design, configuration, and implementation of Werum PAS-X systems to ensure seamless integration with existing pharmaceutical manufacturing processes. • Project Leadership: Take charge of automation projects, from inception to completion, ensuring adherence to project timelines and budget constraints. • Compliance: Ensure all automation processes comply with industry regulations, including GMP (Good Manufacturing Practices) and FDA guidelines. • System Maintenance: Oversee the maintenance, troubleshooting, and optimization of Werum PAS-X systems to ensure maximum uptime and operational efficiency. • Validation: Manage the validation and qualification processes for automation systems, ensuring they meet industry standards and regulations. • Documentation: Maintain comprehensive documentation of automation processes, including SOPs (Standard Operating Procedures) and change control documentation. • Training: Provide training and support to colleagues and team members to ensure their proficiency in Werum PAS-X systems. • Continuous Improvement: Identify opportunities for process optimization and efficiency improvements within the automation systems and propose solutions. What are the Mandatory skills and skill proficiencies required for this position? • Minimum of 10 years of experience in the pharmaceutical industry with a focus on automation and Werum PAS-X systems. (5) • Strong knowledge of GMP, FDA regulations, and industry best practices. (5) • Proficiency in Werum PAS-X and other pharmaceutical automation systems. (5) • Project management experience, with the ability to lead cross-functional teams. (4) • Excellent problem-solving skills and the ability to work effectively in a team-oriented environment. (4) • Strong communication and documentation skills. (3) • Bachelor's degree in engineering, Computer Science, or a related field. (3)