Automation Engineer

Job Description

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 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. In this role you must be able to identify critical interfaces between building and equipment systems; interpret P&IDs, wiring diagrams, facility/equipment drawings, and equipment specifications to determine automation strategies for the GMP manufacturing facility; and effectively perform troubleshooting and repair activities.

Key Responsibilities:

Lead design, configuration, and commissioning of DeltaV and PAS-X automation systems for GMP-critical manufacturing equipment and process controls.

Support change controls, deviations, and CAPAs involving DeltaV and PAS-X logic, batch strategies, and alarm configuration in collaboration with QA and Validation.

Develop and modify control modules, phases, and equipment modules within DeltaV in alignment with S88 batch architecture standards.

Provide hands-on troubleshooting and root cause analysis for DeltaV and PAS-X system issues during routine operations and project start-up phases.

Collaborate with cross-functional teams (Process Engineering, QA, Validation, and Manufacturing) to align automation changes with business needs.

Author and review technical documentation including Functional Design Specs (FDS), software requirement specs, and test protocols.

Interface with PAS-X MES and data historians to ensure integration and data continuity across digital systems.

Participate in system upgrades, patching, and security hardening activities to maintain compliance and cyber-resilience of DeltaV and PAS-X environments.

Train and mentor site engineers/operators on DeltaV and PAS-X operations, change management, and system maintenance best practices.

Ensure automation compliance with GAMP 5, FDA 21 CFR Part 11, and relevant corporate SOPs and regulatory requirements.

Requirements

Bachelor’s degree in Chemical, Electrical, Mechanical, Biomedical Engineering, or Computer Science with appropriate industrial controls experience.

4+ years of experience in manufacturing support environment, as a system integrator or automation engineer.

PLC and DCS coding, installation, and support, including but not limited to Allen Bradley, Siemens, and DeltaV.

Understanding and configuration of systems such as PI, Win-911, and InfoBatch.

Experience with analytical equipment such as balances, pH/DO meters, Nova FLEX2, Beckman Coulter Vi-CELL, filter integrity testers, etc.

Understanding of instrumentation, electrical, and wiring standards.

Understanding of network architecture, including firewall and switch configuration and virtualized environments.

Familiarity with industry standard communication protocols such as Ethernet IP, PROFINET, Modbus TCP, OPC, and BACnet.

Experience with current trends in automation and instrumentation to be able to select and implement modern controls architectures.

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)

Full-time