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Automation and Computer System Validation (CSV) Engineer

STADA M&DTurda, RO

În urmă cu peste 30 de zile

Descrierea postului

STADA Romania unveils its visionary expansion with a EUR 60 million investment in Turda, Romania. Positioned strategically at the heart of European markets, this state-of-the-art supply-chain hub is more than a facility; it’s STADA’s commitment to innovation, growth, and community welfare.

With 375 jobs in the pipeline, the facility signifies a pivotal chapter for STADA Romania, delivering on sustainable goals and advancing healthcare across Europe.

Join our team at STADA Technical Operations Romania, and contribute to the advancement of pharmaceutical manufacturing through automation and validation compliance.

We're seeking a dedicated Automation and CSV Engineer to maintain and enhance our automation systems while ensuring regulatory compliance.

Responsibilities :

Resolve Automation System Issues : Serve as the go-to expert for troubleshooting automation system problems, including deviation investigation and trend analysis, leveraging available data for effective resolution.
Manage External Contractors : Oversee external contractors to ensure proper modification and maintenance of automation systems, utilities, and equipment, optimizing plant operation and reliability.
Drive Continuous Improvement : Lead initiatives to enhance automation efficiency and reliability, identifying opportunities for process automation within manufacturing operations.
Maintenance and Documentation : Take charge of corrective and preventive maintenance for production equipment, ensuring adherence to GMP standards and maintaining relevant engineering documentation.
Training and Support : Provide training for associates on automation systems and offer coaching on automation topics within the designated area of responsibility.

Requirements :

Bachelor's Degree in Engineering : Specialization in Automation, Electronics, or Mechatronics.

1-3 Years of Automation Systems Experience : Preferably within the pharmaceutical industry.

Programming and Control System Knowledge : Familiarity with ISA95 level 1-2-3 control system components, PLC, HMI, SCADA, and ERP systems preferred.

Regulatory Understanding : Knowledge of computer system validation (CSV) requirements, cGMP, and regulatory standards.

Technical Proficiency : Strong technical writing skills for protocol generation and technical reports, along with excellent computer skills.

Adaptability and Problem-Solving : Ability to thrive in a fast-paced environment, demonstrating problem-solving and analytical skills.

Team Player : Collaborative mindset with a customer-oriented approach, fostering effective teamwork and integration.

Around 13,000 employees globally live our values of Integrity, Entrepreneurship, Agility and One STADA. Together we are on an exciting growth journey and want to successfully shape the future of STADA.

STADA Group promotes its diverse culture, regardless of gender, age, social or ethnic origin, disability, religion, ideology or sexual orientation. We use the strength of this diversity to develop creative ideas, expand our experience and increase our innovative strength. Our focus is on equal opportunities, respectful cooperation and the promotion of an inclusive working environment.