HW3
Overview
Process Controls & Automation Specialist | US Life Sciences | Contract Recruitment. We are supporting a leading pharmaceutical manufacturer in the Greater Boston area seeking an experienced DeltaV Automation Engineer to join their team on a long-term project. This position will support automation activities across a GMP manufacturing facility, focusing on process control system configuration, integration, commissioning, and validation for new and existing production lines. You’ll play a key role in ensuring systems are designed, implemented, and maintained in full compliance with GxP and FDA regulations, working cross-functionally with operations, validation, and quality teams. Key Responsibilities
Configure, modify, and troubleshoot Emerson DeltaV Distributed Control Systems (DCS) for batch and continuous processes. Support project lifecycle phases including URS development, design, FAT/SAT execution, commissioning, and validation. Collaborate with process engineers, validation, and QA to implement automation changes and maintain compliance with 21 CFR Part 11 and GAMP 5 guidelines. Develop and maintain system documentation, including functional specifications, design documents, and test protocols. Participate in change control, deviation investigation, and system improvement initiatives. Provide on-site and remote support during startup, qualification, and production phases. Assist with system upgrades, patch management, and lifecycle planning. Support data integrity, audit trail reviews, and system backup/restore verification. Requirements
3–8 years of experience in automation engineering within the pharmaceutical, biotech, or life sciences industry. Hands-on experience with Emerson DeltaV (configuration, troubleshooting, and batch programming). Knowledge of GxP, cGMP, 21 CFR Part 11, and validation documentation. Experience supporting commissioning, qualification, and validation (CQV) activities. Strong understanding of process automation, instrumentation, and control system integration. Excellent communication and documentation skills. Preferred Skills
Experience with OSI PI, MES integration, or data historian systems. Familiarity with virtualized DeltaV environments or DeltaV Live. Exposure to continuous improvement or lean manufacturing initiatives. Previous experience with large-scale greenfield or expansion projects. Seniority level
Mid-Senior level Employment type
Full-time Industries
Pharmaceutical Manufacturing Biotechnology Research Chemical Manufacturing
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Process Controls & Automation Specialist | US Life Sciences | Contract Recruitment. We are supporting a leading pharmaceutical manufacturer in the Greater Boston area seeking an experienced DeltaV Automation Engineer to join their team on a long-term project. This position will support automation activities across a GMP manufacturing facility, focusing on process control system configuration, integration, commissioning, and validation for new and existing production lines. You’ll play a key role in ensuring systems are designed, implemented, and maintained in full compliance with GxP and FDA regulations, working cross-functionally with operations, validation, and quality teams. Key Responsibilities
Configure, modify, and troubleshoot Emerson DeltaV Distributed Control Systems (DCS) for batch and continuous processes. Support project lifecycle phases including URS development, design, FAT/SAT execution, commissioning, and validation. Collaborate with process engineers, validation, and QA to implement automation changes and maintain compliance with 21 CFR Part 11 and GAMP 5 guidelines. Develop and maintain system documentation, including functional specifications, design documents, and test protocols. Participate in change control, deviation investigation, and system improvement initiatives. Provide on-site and remote support during startup, qualification, and production phases. Assist with system upgrades, patch management, and lifecycle planning. Support data integrity, audit trail reviews, and system backup/restore verification. Requirements
3–8 years of experience in automation engineering within the pharmaceutical, biotech, or life sciences industry. Hands-on experience with Emerson DeltaV (configuration, troubleshooting, and batch programming). Knowledge of GxP, cGMP, 21 CFR Part 11, and validation documentation. Experience supporting commissioning, qualification, and validation (CQV) activities. Strong understanding of process automation, instrumentation, and control system integration. Excellent communication and documentation skills. Preferred Skills
Experience with OSI PI, MES integration, or data historian systems. Familiarity with virtualized DeltaV environments or DeltaV Live. Exposure to continuous improvement or lean manufacturing initiatives. Previous experience with large-scale greenfield or expansion projects. Seniority level
Mid-Senior level Employment type
Full-time Industries
Pharmaceutical Manufacturing Biotechnology Research Chemical Manufacturing
#J-18808-Ljbffr