Job Description
Job Title: Senior Automation Engineer Job Location: Muskegon, MI (100% On-site) Job Duration: Long-term Contract Job Type: Contract Experience Required: 8+ Years Industry Focus: Pharmaceutical/Bio-Pharmaceutical Manufacturing Job Overview: The Senior Automation Engineer serves as a critical technical lead in the commissioning and qualification (C&Q) phase of large-scale biopharmaceutical manufacturing. This role is responsible for ensuring the integrity and operational readiness of DeltaV Distributed Control Systems (DCS). The successful candidate will operate with a high degree of autonomy, providing the technical oversight necessary to resolve complex automation challenges in real-time, thereby ensuring project milestones are met within a highly regulated GMP environment. Technical Depth: Candidates must demonstrate the ability to apply ISA-88 standards to batch processes and possess a nuanced understanding of Validation protocols. While this role does not require primary authorship of Computer System Validation (CSV) documents, the engineer must provide the technical evidence and execution support necessary to satisfy CSV requirements and ensure the system remains in a validated state. About the Opportunity: This is a high-impact role requiring a professional who balances deep technical expertise with the leadership skills necessary to drive a project to completion. We offer a professional environment where technical precision and commitment to quality are paramount. Core Competencies Platform Expertise: Advanced proficiency in Emerson DeltaV DCS (Control system logic, phases, and automation components). Regulatory Frameworks: Deep functional knowledge of ISA-88 (Batch Control), GAMP 5 , and 21 CFR Part 11 . Lifecycle Management: Comprehensive understanding of the Commissioning & Qualification (C&Q) lifecycle. Problem Solving: Expert-level triage and rapid resolution of automation-related issues in live manufacturing environments. Key Responsibilities System Configuration & Support: Independently troubleshoot and configure DeltaV control system logic and phases to align with approved Functional Specifications. C&Q Execution: Lead automation-related support for test execution, including issue investigation, remediation strategies, and preparation for re-testing. Technical Leadership: Provide real-time mentorship and technical guidance to junior and intermediate engineers, acting as the primary subject matter expert for on-site automation queries. Change Control Management: Identify automation discrepancies, propose technical solutions, and manage the implementation of fixes under strict site-specific change control protocols. Stakeholder Collaboration: Partner with cross-functional teams to ensure that automated system behavior meets rigorous safety and quality expectations. Compliance Oversight: Maintain absolute adherence to applicable GMP requirements, safety standards, and site procedures during all execution phases.