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Automation C&Q Specialist
2 weeks ago
Automation C&Q Professional
We are seeking an experienced Automation C&Q professional to lead the commissioning and qualification of automation systems.
- Develop and execute comprehensive C&Q protocols for DCS, SCADA, PLCs, and MES systems, ensuring compliance with GMP, GAMP, and FDA guidelines.
- Collaborate with cross-functional teams, including engineering, validation, and quality assurance, to ensure seamless integration of automation systems.
- Oversight of testing, debugging, and validation of automation software and hardware, guaranteeing data integrity and regulatory compliance.
- Provide technical guidance and mentorship to junior engineers and technicians, promoting skill development and knowledge sharing.
- Management of documentation related to automation qualification, including URS, FAT, SAT, IQ, OQ, and PQ reports.
- Cordination with vendors and contractors for installation, commissioning, and troubleshooting of automation equipment.
Required Qualifications & Skills:
- Bachelor's degree in Electrical Engineering, Automation Engineering, or a related field.
- Minimum 12 years of experience in automation engineering, preferably in pharmaceutical manufacturing.
- Strong expertise in DCS (DeltaV, PCS7), SCADA, PLCs, and MES systems.
- In-depth knowledge of GMP, GAMP 5, FDA 21 CFR Part 11 compliance.
- Experience in commissioning and qualification of automation systems.
- Excellent problem-solving and analytical skills.
- Strong communication and leadership abilities.
- Ability to work in cross-functional teams and manage multiple stakeholders.
