Azzur Group is a GxP compliance and consulting organization focused on providing quality-driven solutions that propel life science companies toward success. We are currently seeking candidates who are passionate about ensuring the highest standards of quality in the pharmaceutical and biotechnology sectors. If you're a dedicated professional with a desire to engage, learn, and adapt within a dynamic healthcare landscape, you will fit right into our core values: Put Others First, Have the Courage to Take Action, Take Personal Responsibility, and Have Fun!
Azzur Group is seeking an experienced Automation CQV Engineer to join our team in the Boston area. The ideal candidate will be responsible for the Commissioning, Qualification, and Validation (CQV) of automated systems in pharmaceutical manufacturing, with a primary focus on DeltaV-based control systems and automated filling and packaging equipment. This position requires a hands-on, onsite presence to ensure successful project execution and compliance with Good Manufacturing Practices (GMP) standards.
Key Responsibilities:
Lead the design, configuration, testing, and troubleshooting of DeltaV Distributed Control Systems (DCS) and associated automated systems. Execute CQV protocols (IQ, OQ, PQ) for automated filling and packaging systems in alignment with regulatory requirements. Collaborate effectively with cross-functional teams (Engineering, QA, Manufacturing) to support system integration, upgrades, and continuous improvements. Develop and maintain detailed technical documentation, including Standard Operating Procedures (SOPs), User Requirements Specifications (URS), Functional Specifications (FS), and Validation Protocols. Provide ongoing system support, troubleshooting, and optimization to ensure the reliability and performance of automated systems in a production environment.