RESOLVIT

Bringing Solutions That Make Business Better

We are seeking a Senior CSV Automation Engineer to be part of a creative, forward-thinking team. Our success at deploying skilled, highly knowledgeable experts has landed us on the Inc. 5000 list of America’s fastest-growing companies four times – and we’re just getting started.

As the Senior CSV Automation Engineer, you will manage and execute projects related to industrial machine automation for both new and existing equipment and computer system validation (CSV) of the equipment/systems. You will support the site’s strategy by ensuring the production equipment is available to produce when needed and to deliver product per customer demand. You will also lead complex projects with teams comprised of internal and external stake holders to deliver projects on time and at budget target. Additionally, you will: 

• Lead the computer system validation of instrumentation and control systems including process control, data collection, and historian systems for analytics, building automation systems, and production equipment PLCs
• Accountable for the lifecycle scope for GxP Automation Systems starting with project initiation and continuing through the project phases of planning, design, procurement, construction, commissioning, and control system qualification/validation
• Provide technical leadership and accountability for computer system validation engineering standards and computer systems validation for all site manufacturing Automation Systems
• Ensure the successful delivery and maintenance of the computerized system validation life cycle to ensure compliant and reliable Automation Systems
• Prepare, review, and approve Computerized System Validation protocols, reports, and procedures for GxP computerized systems
• Develop the validation protocols, plans, and reports for validation of control systems
• Provide technical expertise and management for projects, review and approval of change controls, and audit all CSV documentation for compliance with current corporate, FDA, and regulatory requirements
• Manage change controls for changes to computerized systems
• Provide technical support (particularly for validation for computerized systems) for existing instrumentation and automation systems
• Analyze repairs and maintenance requirements in order to proactively address system weaknesses
• Develop validation documentation and implement validation plans, instrumentation, and control systems
• Provide formalized training to other engineers, technicians, and qualification staff for practical implementation of CSV at site
• Interface with users, peers, and management to ensure appropriate input and integration of local and corporate standards
• Provide technical expertise during regulatory audits
• Author, review, revise, or approve Standard Operating Procedures as required
• Be responsible for on time Compliance records of Automation Department
• Participate in site Operational Excellence initiatives
• Participate on cross-functional teams to address specific problems, facilitate discussion and research, enable procedures to become more efficient, and to build and enhance interdepartmental relationships
• Provide technical support (particularly for validation for computerized systems) for utility systems including but not limited to purified water systems, compressed air systems, chilled water systems, and steam systems
• Perform all job responsibilities in compliance with applicable regulations, standard operating procedures, and industry practice

What You’ll Need to be Successful:

• At least 3 years of automation (industrial controls) experience
• At least 3 years of experience in the life sciences industry
• At least 7 years of combined demonstrated experience in cGMP automation/computerized systems, quality, and compliance areas of the life sciences industry
• Bachelor’s in engineering with experience in control systems engineering (automation)
• Experience with 21 CFR Part 11 cGMP requirements for electronic records, electronic signatures, system validation strategies, and documentation
• Experience with process controls equipment including for example PLCs, BMS, Batch, HMIs, SCADA systems, SQL relational database systems, and network equipment including design and debugging skills in a pharmaceutical or related industry
• Experience with technical writing and report generation of testing methodologies of automation systems

Great Additional Skills:

• Bachelor’s degree in control systems engineering, electrical engineering, mechanical engineering, or chemical engineering
• Thorough understanding of industry standards and best practices for computer system validation such as GAMP 5
• Strong understanding of System Validation Life Cycle, testing, and QA methodologies

We currently have more than 100 open career opportunities across the country, so be sure to mention the appropriate Job Code with any correspondence!

About Resolvit:

Resolvit is an international technology consulting firm with industry-leading customers in the financial services, high tech, manufacturing, retail, life sciences, and government sectors. Through its partnerships, Resolvit delivers highly impactful, innovative solutions across five core areas: Infrastructure Modernization, Application Development Services, Enterprise Data Management & Analytics, Knowledge & Content Management, and Strategic Staffing.