Senior MES Engineer - Life Sciences Job at BlackStar, Raleigh, NC

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  • BlackStar
  • Raleigh, NC

Job Description

About the Role:

The Company is seeking a highly experienced Senior MES Engineer to lead the design, development, and deployment of Manufacturing Execution Systems (MES) for Life Sciences clients. This position is ideal for someone with deep technical expertise, strong leadership capabilities, and a proven background in MES implementation using platforms such as Werum PAS-X, Sepasoft, or POMS .

You will act as a Solution Architect and Technical Lead , working closely with cross-functional teams to deliver robust MES solutions that integrate seamlessly with systems such as SAP, DeltaV, LIMS, PI, Maximo , and more. If you're passionate about smart manufacturing, regulatory compliance, and digital transformation in a GMP environment, we want to hear from you.

Key Responsibilities:

  • Lead end-to-end MES projects from strategy and design to implementation and qualification.
  • Collaborate directly with clients to assess needs, evaluate MES platforms, and develop detailed functional specs.
  • Oversee the integration of MES with Level 2 (automation) and Level 4 (enterprise) systems.
  • Develop and implement EBR recipes aligned with GAMP5, ISA-88, and ISA-95 standards.
  • Provide mentorship to junior engineers and lead multidisciplinary project teams.
  • Manage project budgets, execution timelines, and ensure profitability.

  • Ensure MES solutions meet cGMP and 21 CFR Part 11 compliance standards.

Required Qualifications:

  • Bachelor's degree in Engineering, Computer Science, or related field.

  • 10+ years of experience delivering MES solutions in the Life Sciences industry .
  • Expertise in Werum PAS-X, Sepasoft, or POMS .

  • Strong background with relational databases (SQL, Oracle) and historian/reporting systems .
  • Proven experience integrating MES with DeltaV, SAP, LIMS, PI, and Maximo .
  • In-depth understanding of warehouse/inventory systems in GMP environments.
  • Demonstrated success leading cross-functional teams and delivering large-scale MES projects.
  • Willingness to travel up to 25%.

Preferred Skills:

  • Excellent communication and technical documentation skills.

  • Strong knowledge of IT/OT networking .

  • Experience acting as both a Technical Lead and a  Project Manager .

  • Positive references from a manager, peer, and subordinate .

Interview Process:

  1. Phone Screen with Talent Advisor

  2. Technical Interview (Video with Hiring Manager)

  3. Final Interview (Onsite)

Apply today to join a high-impact engineering team where your expertise in MES and life sciences will drive real-world results.

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