Automation Specialist Position
A challenging opportunity has arisen for an experienced automation specialist to take on the role of technical support and program management in manufacturing operations and New Product Introductions (NPIs). As an automation specialist, you will be responsible for providing technical expertise and project leadership to deliver continuous improvement projects.
Main Responsibilities
* Provide technical assistance with control system-related issues.
* Lead control system qualification activities during project start-up.
* Maintain onsite control systems, adhering to GAMP-5 requirements.
* Manage control system elements of continuous improvement projects.
* Collaborate with process engineers, technical support chemists, and other departments to execute these projects.
* Develop and manage future integrations of control systems with planned MES and ERP systems.
* Ensure compliance with EHS & E standards, procedures, and policies.
* Propose long-term plans for control system maintenance and improvements for senior management.
* Maintain adherence to EHS policy and procedures, demonstrating best practices in all work activities.
About You
* Bachelor's degree or higher in a relevant technical discipline.
* Demonstrated technical or business acumen.
* At least 3 years of experience in process automation, preferably in a GMP environment within the pharmaceutical industry.
* Familiarity with Vendor Packaged Equipment and its applications.
* Experience working with automated systems in a pharmaceutical setting, adhering to 21 CFR Part 11 and EU Annex 11 requirements.
* Proven ability to lead start-up activities in a new product introduction environment.
* Strong knowledge of complex equipment control systems, including PLC systems, SCADA/HMI applications, and network architecture models.
* Familiarity with interfacing systems with plant historians using OPC interfaces.
* Knowledge of life cycle management of control systems, including backup, recovery, user access controls, configuration management, and change management.