Process Control System SME

• Lead the architecture setup and standardization of the Process Control System.
• Oversee the implementation of PCS solutions from design to validation.
• Maintain and support PCS functionality during operations., Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Cleanroom: no hair products, jewelry, makeup, nail polish, perfume, exposed piercings, facial hair etc... allowed, Office, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.), As part of the Thermo Fisher Scientific team, you'll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner and safer. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the world's toughest challenges, like protecting the environment, making sure our food is safe or helping find cures for cancer., * Act as an expert and drive the architecture setup, development, and standardization of the Process Control System (PCS)
• In the project phase, be responsible and accountable for the implementation of PCS solutions, including: System design, Hardware and software setup, Commissioning and start-up, Validation of both software and hardware components
• Ensure the PCS is implemented in line with site standards and regulatory requirements
• In the operational phase, maintain and support the functionality and availability of the PCS
• Ensure business continuity through reliable system operation, issue resolution, and controlled changes
• Provide ongoing technical expertise and support for PCS throughout the system lifecycle

• 5+ years in project execution for complex computerized systems.
• Expertise in Siemens PCS7 and automation technologies.
• Knowledge of cGMP regulations and ISA standards., * Minimum 5 years of successful project execution and major projects for computerized systems with high complexity and interfaces to other applications (SCADA, Process Control System, Clean Utilities Automation, Facility Monitoring System, Building Management System, Manufacturing Execution System), biotech/pharmaceutical or other industries.
• Proven experience with Siemens PCS7.
• Confirmed experience and knowledge in Automation, Hardware design, Software Design, PLC technology.
• In-depth working experience in regulated industries; knowledge of cGMP, 21 CFR part11 and validation is a plus.
• Proven project execution skills including document development and software implementation.
• Knowledge of active directory, DNS, IP networks and virtualization is a plus.
• Proven knowledge and understanding of ISA 95 and ISA 88 standards.
• Confirmed experience in cGxP qualification.
• Experience in support of multi-site projects is a plus.
• Fluent in written and spoken English; German proficiency is an advantage.

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