MES CSV Engineer

E Tech Group • Boston, MA

21h

About The Position

At E Tech Group, joining our team means joining a group of passionate and forward-thinking experts. We're one of the largest engineering and system integration firms in the United States providing value for our clients through IT automation and control solutions for more than 30 years to the Life Sciences, Mission Critical, Metals & Mining, Warehousing & Distribution, and CPG/Food & Beverage industries. Our national and global scale allows us to help our clients develop and implement standardized solutions at any of their facilities regardless of physical location or the local resources available at that site.

We are seeking an enthusiastic and experienced MES CSV (Computerized Systems Validation) Engineer to be responsible for coordination, development, and review of validation documentation for projects requiring GAMP 5 and 21CFR Part 11 compliance. This individual will work with project teams, leading the documentation effort for automated control system design. development, testing, and deployment.

Requirements

• BS/BA in engineering, computer science, IT, or equivalent technical discipline
• Working knowledge of Process automation, MES and batch manufacturing industry standards (ISA 88 and 95)
• 1+ years of direct experience with MES or Automation systems (SCADA, DCS, PAT, Data historian) in regulated manufacturing industry.
• 1+ years in validation and lifecycle activities mapping user requirements to draft/execution of test protocols, and traceability matrix generation
• 3+ years engineering, troubleshooting, or solutions design of Emerson Syncade , DeltaV or other Life Sciences focused on MES systems.
• Ability to manage projects from simple to complex, ensuring on-time delivery and high-quality results.
• Adept at coordinating tasks, maintaining timelines, and managing resources.
• Capable of identifying and resolving technical issues
• Aptitude for developing, adhering to, and continuously improving operation and maintenance procedures for process controls and manufacturing execution systems.
• Ability to adapt to changes and new requirements quickly.
• Strong verbal and written communication skills to effectively collaborate with stakeholders, explain technical concepts, and document processes and changes.
• A DNA comprised of collaboration and teamwork.

Responsibilities

• Simulate and validate components and recipes for MES Syncade and PAS DeltaV.
• Author test scripts, test cases, and/or SDLC documents using electronic validation tool and electronic document management system (EDMS)
• Execute test scripts using electronic validation tool, and interface with cross-functional teams to clear roadblocks and route deliverables for approval.
• Perform Installation Qualification protocols for recipe authoring objects contained within the Syncade and DeltaV systems.
• Adhere to quality and validation practices, SOPs, and guidelines during validation activities.
• Comply with data integrity and computer system validation requirements and regulations as a part of MES system or recipe build and testing.
• Assess the risk and impact the changes, patches, outages, or other events can have on MES solution.
• Understand the changes that impact validated state of an application and underlying infrastructure.
• Understand interfaces to ERP(Enterprise resource planning), CMMS(Asset calibration system), Quality execution systems including LIMS (Laboratory inventory management system),process control systems and other digital solutions.
• Partner with business stakeholders (business, quality, system owners)
• Be an ambassador who embodies our Core Values, prioritizing the success of E Tech Group, our clients, and the professional development of our associates.

Benefits

• 401k + match + prompt enrollment. E Tech Group employees are 100% vested upon entry.
• Prompt enrollment into Medical, Dental, and Vision benefits.
• Generous paid time off that includes paid vacation, paid holidays, paid family leave and sick time off.
• Learning and growth are key parts of the E Tech culture. We provide you with training and continuing education from day one, so you can advance your career. As an E Tech associate, you can unlock your greatest potential through challenges and opportunities.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level