Job Title: Automation Project Manager
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We are seeking an experienced Automation Project Manager to support our automation projects end-to-end, including concept, design, implementation, and validation. The ideal candidate will have strong technical skills and experience in managing cross-functional teams.
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Responsibilities:
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* Develop, configure, and deploy PLC, SCADA, DCS, MES, and HMI automation systems.
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* Implement process control strategies to optimize manufacturing and laboratory operations.
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* Collaborate with cross-functional teams (Engineering, IT, Quality, Production) to integrate automation solutions.
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* Provide technical support for automation-related issues, minimizing downtime.
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* Conduct root cause analysis (RCA) and implement corrective actions for system failures.
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* Ensure systems are validated, calibrated, and maintained according to regulatory requirements.
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* Ensure adherence to c GMP, FDA 21 CFR Part 11, GAMP 5, EU Annex 11, and other regulatory standards.
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* Develop and maintain technical documentation, including URS, FDS, HDS, SDS, IQ/OQ/PQ protocols.
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* Participate in regulatory audits and inspections, providing automation-related compliance support.
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* Drive process automation enhancements to improve manufacturing efficiency and reduce operational costs.
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Requirements:
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The ideal candidate should have the following qualifications:
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Bachelor's or Master's degree in Automation, Mechanical, Electrical, or Industrial Engineering
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35 years of experience in automation within the pharmaceutical, biotech, or life sciences industry
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GAMP 5 Practitioner Certification Certified Automation Professional (CAP) Six Sigma / Lean Manufacturing Certification PMP (Project Management Professional)
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Expertise in PLC programming (Siemens, Allen-Bradley, Schneider, etc.)
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Experience with SCADA/DCS systems (Wonderware, Delta V, Rockwell, Siemens PCS7, etc.)
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Knowledge of MES (Manufacturing Execution Systems) such as Werum PAS-X, Rockwell Pharma Suite
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Proficiency in industrial communication protocols (OPC, Modbus, Profibus, Ethernet/IP)
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Familiarity with robotic automation, vision systems, and data analytics tools
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Basic scripting/programming (Python, SQL, VBA, C#) for data handling and automation tasks
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Strong problem-solving and troubleshooting skills
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Excellent communication and collaboration with cross-functional teams
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Ability to work in a regulated environment and handle documentation
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