What are the responsibilities and job description for the Automation CQV Engineer position at Azzur Group?
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.
- 5-7 years of experience in automation engineering, specifically with DeltaV systems and CQV activities for automated equipment in a regulated environment.
- Strong hands-on experience with filling and packaging systems used in biopharma or pharmaceutical manufacturing.
- Bachelor’s degree in Science, Engineering, or a related technical field.
- In-depth knowledge of pharmaceutical manufacturing practices, particularly GMP compliance.
- Excellent communication skills, with the ability to collaborate across teams and document technical information clearly.
- Strong problem-solving abilities and attention to detail.
- Health Care Plan (Medical, Dental & Vision)
- Retirement Plan (401k, IRA)
- Life Insurance (Basic, Voluntary & AD&D)
- Paid Time Off (Vacation, Sick & Public Holidays)
