Automation Engineer (DeltaV) Location: New Jersey - HybridProject: Cell Therapy Manufacturing ProjectWe are looking for an experienced Automation Engineer with DeltaV expertise to oversee commissioning and qualification efforts, ensuring automation systems meet project and regulatory compliance standards required for production readiness. Key Responsibilities 1. Document Control The Automation Engineer will manage the lifecycle of all project-related documents for automation and commissioning activities. This includes: Setting up and maintaining a structured storage system in the designated document repository, ensuring proper organization, accessibility, and security.Uploading, tracking, and revising documents in real-time to align with project progress.Routing documents for review and approval to ensure compliance with established procedures.Ensuring all documentation complies with Good Documentation Practices (GDP) and is finalized for audit readiness. 2. Commissioning Phase Deliverables During the commissioning phase, the Automation Engineer will generate and oversee the following key deliverables: System-Based Commissioning Schedules: Develop schedules that outline the order and timeline for commissioning activities, with clear milestones.System Boundaries Documentation: Define and document system boundaries to clarify the scope of commissioning for each subsystem.Vendor Management Documentation: Prepare and track documentation for vendor interactions, including startup protocols, handover documents, and equipment certifications.Factory Acceptance Testing (FAT) Reports: Complete and document all FAT processes, verifying that the equipment functions per specifications before delivery to the site.Receipt Verification: Conduct inspections and verification checks upon receiving equipment to ensure it matches project specifications and is ready for installation.Site Acceptance Testing (SAT): Perform on-site tests to validate that the equipment operates correctly within the installed environment, producing a detailed SAT report. 3. Execution Phase Deliverables As part of the qualification and validation execution, the Automation Engineer will develop and manage the following deliverables: Installation Qualification (IQ) Protocols and Reports: Document the installation process, verifying that all components are installed according to design specifications and safety standards.Operational Qualification (OQ) Protocols and Reports: Ensure equipment performs as expected in its operational environment by executing OQ protocols and documenting results.Performance Qualification (PQ) Protocols and Reports: Validate that the system meets all performance criteria and supports manufacturing needs, with comprehensive PQ documentation.Change Management Documentation: Track and manage any changes to the systems or processes during execution, including engineering change forms and logs.Traceability Assessment: Confirm that all equipment and processes align with project specifications and regulatory standards, providing a clear record of system traceability.Environmental, Health, and Safety Documentation: Ensure all automation activities comply with site and regulatory safety requirements, documenting any risks, mitigations, and safety tests. Additional Responsibilities Regular Project Reporting: Provide consistent updates on commissioning and execution progress, budget, and schedule adherence.Cross-Functional Collaboration: Work with C&Q, quality, and engineering teams to coordinate all automation deliverables and activities.Vendor Management: Liaise with vendors for equipment setup, testing, and troubleshooting, ensuring deliverables meet project standards. Qualifications: Bachelor’s degree in Electrical Engineering, Computer Science, or related field.Minimum of 5 years of experience in automation engineering, specifically with DeltaV systems, within a GMP-regulated environment.Proficiency in DeltaV systems and experience with electronic documentation systems.Strong communication, documentation, and problem-solving skills.Ability to work collaboratively in a dynamic, team-oriented environment.   Darwin Recruitment is acting as an Employment Agency in relation to this vacancy