ESRhealthcare
Overview
Senior MES Engineer Raleigh, NC
Education level: Bachelor’s degree; Experience level: Mid-senior; Experience required: 10+ years; Job function: Engineering; Industry: Industrial Automation; Relocation assistance: No; Visa sponsorship eligibility: No
Responsibilities
Lead a team of Wunderlich-Malec engineers in identifying requirements, evaluating MES platforms, developing specifications, and implementing/testing/commissioning/qualifying MES solutions.
Interact directly with the customer and serve as a solution architect for MES solutions that integrate process knowledge, equipment design, and quality standards with information technology to reduce downtime and improve regulatory compliance and efficiency.
Develop and implement an MES strategy that integrates process knowledge, equipment design, and quality standards with IT to achieve efficiency gains.
Manage project execution plans, work breakdown structures, budgets, scheduling, time tracking, and reporting; oversee daily project operations up to $1M and help ensure project profitability.
Provide leadership to lower-level engineers and technicians; act as technical lead and mentor for- and on smaller projects as Project Manager as needed.
Engage in activities to secure repeat work with new and existing customers by delivering innovative MES solutions and design standards.
Qualifications
Education: Bachelor of Science degree in Engineering, Computer Science, or the Applied Sciences.
Experience: 10+ years with capabilities in MES deployment (e.g., Werum PAS-X, Sepasoft, POMS) and full project life cycle (conceptual, basis of design, implementation, testing, start-up, commissioning) in the Life Science industry.
Familiarity with regulatory requirements (cGMP, 21 CFR Part 11) and GAMP5, S88, S95 standards for EBR recipes.
Understanding of manufacturing processes, system configuration, and recommendations for optimal MES configurations; knowledge of warehouse/inventory management in GMP facilities.
Experience supporting interfaces with DeltaV, SAP, LIMS, PI, and Maximo; strong historian technology and reporting knowledge.
Proficiency with relational databases (SQL, Oracle, etc.) and IT/OT networking; excellent technical writing and verbal communication skills; working knowledge of MS Office.
Experience leading teams of engineers/technicians and mentoring less experienced engineers; ability to travel up to 25%.
Physical Demands Seeing, color perception, hearing, clear speech, dexterity in hands, driving, lifting, ability to mount/dismount equipment, pushing and pulling.
Working Environment Standard office environment, on-site office environment, diverse industrial environments, frequent use of a personal computer, facsimile/copy machines, and phones.
About Wunderlich-Malec As a 100% Employee-Owned Company our people are passionate about solving your unique engineering challenges, and with the support of industry experts behind them, they can successfully execute projects of any size while meeting your requirements of scope, schedule, and budget. Wunderlich-Malec has been providing customers with engineering, system integration and fabrication solutions for more than 40 years. With offices throughout the US and over 500 professionals on our staff, we are one of the largest and most well-established engineering companies in the United States, and we\'ve successfully finished numerous projects for our US clients in many parts of the world. We\'re confident that our qualified staff has the knowledge, experience, and talent to create and deliver the solutions you need for your facility process and operation needs. Wunderlich-Malec ranks on Inc. 5000\'s Fastest-Growing Private Companies list and is a GSA Schedule holder with the Federal Government for professional engineering services and manufacturing.
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Education level: Bachelor’s degree; Experience level: Mid-senior; Experience required: 10+ years; Job function: Engineering; Industry: Industrial Automation; Relocation assistance: No; Visa sponsorship eligibility: No
Responsibilities
Lead a team of Wunderlich-Malec engineers in identifying requirements, evaluating MES platforms, developing specifications, and implementing/testing/commissioning/qualifying MES solutions.
Interact directly with the customer and serve as a solution architect for MES solutions that integrate process knowledge, equipment design, and quality standards with information technology to reduce downtime and improve regulatory compliance and efficiency.
Develop and implement an MES strategy that integrates process knowledge, equipment design, and quality standards with IT to achieve efficiency gains.
Manage project execution plans, work breakdown structures, budgets, scheduling, time tracking, and reporting; oversee daily project operations up to $1M and help ensure project profitability.
Provide leadership to lower-level engineers and technicians; act as technical lead and mentor for- and on smaller projects as Project Manager as needed.
Engage in activities to secure repeat work with new and existing customers by delivering innovative MES solutions and design standards.
Qualifications
Education: Bachelor of Science degree in Engineering, Computer Science, or the Applied Sciences.
Experience: 10+ years with capabilities in MES deployment (e.g., Werum PAS-X, Sepasoft, POMS) and full project life cycle (conceptual, basis of design, implementation, testing, start-up, commissioning) in the Life Science industry.
Familiarity with regulatory requirements (cGMP, 21 CFR Part 11) and GAMP5, S88, S95 standards for EBR recipes.
Understanding of manufacturing processes, system configuration, and recommendations for optimal MES configurations; knowledge of warehouse/inventory management in GMP facilities.
Experience supporting interfaces with DeltaV, SAP, LIMS, PI, and Maximo; strong historian technology and reporting knowledge.
Proficiency with relational databases (SQL, Oracle, etc.) and IT/OT networking; excellent technical writing and verbal communication skills; working knowledge of MS Office.
Experience leading teams of engineers/technicians and mentoring less experienced engineers; ability to travel up to 25%.
Physical Demands Seeing, color perception, hearing, clear speech, dexterity in hands, driving, lifting, ability to mount/dismount equipment, pushing and pulling.
Working Environment Standard office environment, on-site office environment, diverse industrial environments, frequent use of a personal computer, facsimile/copy machines, and phones.
About Wunderlich-Malec As a 100% Employee-Owned Company our people are passionate about solving your unique engineering challenges, and with the support of industry experts behind them, they can successfully execute projects of any size while meeting your requirements of scope, schedule, and budget. Wunderlich-Malec has been providing customers with engineering, system integration and fabrication solutions for more than 40 years. With offices throughout the US and over 500 professionals on our staff, we are one of the largest and most well-established engineering companies in the United States, and we\'ve successfully finished numerous projects for our US clients in many parts of the world. We\'re confident that our qualified staff has the knowledge, experience, and talent to create and deliver the solutions you need for your facility process and operation needs. Wunderlich-Malec ranks on Inc. 5000\'s Fastest-Growing Private Companies list and is a GSA Schedule holder with the Federal Government for professional engineering services and manufacturing.
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