Automation CQV Engineer

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 a Senior Quality Validation Engineer who is 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.

Requirements

• 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.

Benefits

Azzur Group is an equal opportunity employer and promotes a diverse culture in our workplace. We believe that promoting diversity plays an important role in developing top-quality talent, fostering greater innovation and creativity, and enhancing our relationships with customers and the communities in which we operate. All qualified applicants will receive consideration for employment without regard to race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, age, marital status, pregnancy, genetic information, or other legally protected status.

• Health Care Plan (Medical, Dental & Vision)
• Retirement Plan (401k)
• Life Insurance (Basic, Voluntary & AD&D)
• Paid Time Off (Vacation, Sick & Public Holidays)