Automation Project Specialist
As an Automation Project Specialist, you will play a pivotal role in supporting automation projects from inception to delivery. Your responsibilities will encompass conceptualization, design, implementation, and validation of automation systems and equipment.
Working in close collaboration with cross-functional teams, you will be responsible for designing, implementing, maintaining, and optimizing automation systems and equipment. This includes ensuring compliance with regulatory standards and driving continuous improvement initiatives to enhance production efficiency, product quality, and data integrity.
* Develop and deploy PLC, SCADA, DCS, MES, and HMI automation systems.
* Implement process control strategies to optimize manufacturing and laboratory operations.
* Collaborate with Engineering, IT, Quality, and Production teams to integrate automation solutions.
* Provide technical support for automation-related issues, minimizing downtime.
* Conduct root cause analysis and implement corrective actions for system failures.
* Ensure systems are validated, calibrated, and maintained according to regulatory requirements.
* Adhere to cGMP, FDA 21 CFR Part 11, GAMP 5, EU Annex 11, and other regulatory standards.
* Develop and maintain technical documentation, including URS, FDS, HDS, SDS, IQ/OQ/PQ protocols.
* Participate in regulatory audits and inspections, providing automation-related compliance support.
* Drive process automation enhancements to improve manufacturing efficiency and reduce operational costs.
* Stay updated on emerging technologies in Industry 4.0, IoT, data analytics, AI-driven automation.
* Support digital transformation initiatives such as cloud-based automation and electronic batch records (EBR).
Requirements
* Bachelor's or Master's degree in Automation, Mechanical, Electrical, or Industrial Engineering (or related field).
* 3–5 years of experience in automation within the pharmaceutical, biotech, or life sciences industry.
* GAMP 5 Practitioner Certification.
* Certified Automation Professional (CAP).
* Six Sigma / Lean Manufacturing Certification.
* PMP (Project Management Professional).
* Expertise in PLC programming (Siemens, Allen-Bradley, Schneider, etc.).
* Experience with SCADA/DCS systems (Wonderware, DeltaV, Rockwell, Siemens PCS7, etc.).
* Knowledge of MES (Manufacturing Execution Systems) such as Werum PAS-X, Rockwell PharmaSuite.
* Proficiency in industrial communication protocols (OPC, Modbus, Profibus, Ethernet/IP).
* Familiarity with robotic automation, vision systems, and data analytics tools.
* Basic scripting/programming (Python, SQL, VBA, C#) for data handling and automation tasks.
* Strong problem-solving and troubleshooting skills.
* Excellent communication and collaboration with cross-functional teams.
* Ability to work in a regulated environment and handle documentation.