Varwyne Talent Collective
Senior MES Engineer
Varwyne Talent Collective - Raleigh, North Carolina, United States, 27601
Work at Varwyne Talent Collective
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Overview
About the job Senior MES Engineer
Our client is seeking a
Senior MES Engineer
with deep expertise in the Life Sciences industry to lead the design, configuration, and deployment of
Manufacturing Execution System (MES)
solutions. This role requires a high level of technical proficiency, leadership capabilities, and the ability to work directly with customers to deliver high-quality, compliant MES implementations that integrate with both automation (Level 2) and enterprise (Level 4) systems. This is a full-time/permanent position that requires the potential candidate to be onsite in their Raleigh, NC office.
As a Senior MES Engineer, you will lead project efforts, mentor junior team members, and act as a technical point of contact for customers throughout the full project lifecycle from requirements gathering through commissioning and qualification.
Responsibilities:
Serve as the technical lead and solution architect for MES projects, providing design and configuration expertise across platforms such as Werum PAS-X, Sepasoft, or POMS. Interface directly with clients to identify project requirements, evaluate platform options, and develop project specifications. Lead MES solution implementation, including design, testing, commissioning, and qualification. Ensure MES solutions meet cGMP, 21 CFR Part 11, and GAMP5 standards for compliance and validation. Design and implement integrated EBR (Electronic Batch Record) recipes using ISA-88 and ISA-95 frameworks. Develop and support integrations with external systems including DeltaV, SAP, LIMS, OSI PI, and Maximo. Utilize relational databases such as SQL or Oracle to support MES functionality and reporting. Provide leadership and mentorship to junior engineers and contribute to best practices and knowledge sharing within the organization. Support proposal development and contribute to customer retention by delivering high-value technical solutions. Qualifications:
10+ years of experience in MES engineering, with proven success leading full project lifecycles. Life Sciences industry experience is required, including familiarity with regulated manufacturing environments. Strong understanding of regulatory compliance including cGMP, GAMP5, and 21 CFR Part 11. Proficiency in MES platforms such as Werum PAS-X, Sepasoft, or POMSnet. Hands-on experience with relational databases (SQL, Oracle). Knowledge of historian and reporting systems such as OSI PI or AVEVA. Experience integrating MES with enterprise systems such as SAP, LIMS, DeltaV, and Maximo. Ability to conceptualize and implement MES solutions using standards-based design methodologies (ISA-88/95). Excellent problem-solving and client-facing communication skills. Strong organizational and leadership abilities; experience mentoring or managing engineers is a plus. Bachelor of Science in Engineering, Computer Science, or Applied Sciences required.
Our client is seeking a
Senior MES Engineer
with deep expertise in the Life Sciences industry to lead the design, configuration, and deployment of
Manufacturing Execution System (MES)
solutions. This role requires a high level of technical proficiency, leadership capabilities, and the ability to work directly with customers to deliver high-quality, compliant MES implementations that integrate with both automation (Level 2) and enterprise (Level 4) systems. This is a full-time/permanent position that requires the potential candidate to be onsite in their Raleigh, NC office.
As a Senior MES Engineer, you will lead project efforts, mentor junior team members, and act as a technical point of contact for customers throughout the full project lifecycle from requirements gathering through commissioning and qualification.
Responsibilities:
Serve as the technical lead and solution architect for MES projects, providing design and configuration expertise across platforms such as Werum PAS-X, Sepasoft, or POMS. Interface directly with clients to identify project requirements, evaluate platform options, and develop project specifications. Lead MES solution implementation, including design, testing, commissioning, and qualification. Ensure MES solutions meet cGMP, 21 CFR Part 11, and GAMP5 standards for compliance and validation. Design and implement integrated EBR (Electronic Batch Record) recipes using ISA-88 and ISA-95 frameworks. Develop and support integrations with external systems including DeltaV, SAP, LIMS, OSI PI, and Maximo. Utilize relational databases such as SQL or Oracle to support MES functionality and reporting. Provide leadership and mentorship to junior engineers and contribute to best practices and knowledge sharing within the organization. Support proposal development and contribute to customer retention by delivering high-value technical solutions. Qualifications:
10+ years of experience in MES engineering, with proven success leading full project lifecycles. Life Sciences industry experience is required, including familiarity with regulated manufacturing environments. Strong understanding of regulatory compliance including cGMP, GAMP5, and 21 CFR Part 11. Proficiency in MES platforms such as Werum PAS-X, Sepasoft, or POMSnet. Hands-on experience with relational databases (SQL, Oracle). Knowledge of historian and reporting systems such as OSI PI or AVEVA. Experience integrating MES with enterprise systems such as SAP, LIMS, DeltaV, and Maximo. Ability to conceptualize and implement MES solutions using standards-based design methodologies (ISA-88/95). Excellent problem-solving and client-facing communication skills. Strong organizational and leadership abilities; experience mentoring or managing engineers is a plus. Bachelor of Science in Engineering, Computer Science, or Applied Sciences required.