MES Process Engineer

JR United Kingdom; Witney; On-site; GBP 40,000 - 60,000; Full time

Job summary

A leading company in the pharmaceutical sector is seeking a MES Process Engineer to enhance their Manufacturing Execution Systems (MES). The role involves developing and implementing MES functionalities, ensuring compliance with industry standards, and collaborating with global teams. Ideal candidates will have a strong background in pharma or biotech with proven MES experience.

Qualifications

• Minimum 6–12 months of experience with POMSnet.
• At least 3 years of experience with MES in pharmaceutical/biotech manufacturing.
• Minimum 4 years’ relevant industry experience in a regulated environment.

Responsibilities

• Develop, test, and implement MES integration functionalities.
• Design and execute test plans, including validation protocols.
• Document all processes in accordance with cGMP standards.

Skills

Analytical skills

Communication

Collaboration

Education

Bachelor’s or Master’s in Engineering, Computer Science, or related discipline

Job description

We are seeking a MES Process Engineer to support the development, integration, and maintenance of our Manufacturing Execution Systems (MES). This role is critical to ensuring that our MES aligns with Global Operating Specifications and is tailored to the operational needs of our pharmaceutical production environment.

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Key Responsibilities

• Develop, test, and implement MES integration functionalities to support production.
• Design and execute test plans, including validation protocols and risk assessments.
• Ensure alignment of equipment and product procedures with MES workflows.
• Provide support and troubleshooting assistance for MES system users to ensure business continuity.
• Document all processes and activities in accordance with cGMP standards.
• Raise and manage change requests related to MES application upgrades and modifications.
• Design and develop electronic batch records and workflows within the MES environment.
• Drive continuous improvement initiatives across MES platforms.
• Develop and execute User Acceptance Testing (UAT) plans, update Requirements and Use Cases (RuRs), and transition recipes into production systems.
• Collaborate with internal stakeholders and global teams to ensure successful MES deployment and optimization.
• Minimum 6–12 months of experience with POMSnet (candidates without this will not be considered).
• Experience authoring and implementing MES workflows, preferably in Life Sciences, Pharma, or Biotech.
• Deep understanding of MES standards such as ISA-95 and ISA-88, and integration from control layers to MES.
• Proven experience with MES in pharmaceutical/biotech manufacturing for at least 3 years.

Candidate Profile

• Degree qualified (Bachelor’s or Master’s) in Engineering, Computer Science, or a related discipline.
• Minimum 4 years’ relevant industry experience in a regulated pharmaceutical or biotechnology manufacturing environment.
• Strong analytical skills with a keen attention to detail.
• Excellent communication and collaboration abilities to work effectively in fast-paced, cross-functional teams.
• Experience in interpreting complex user requirements and translating them into practical MES solutions and documentation.

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Created on 23/05/2025 by JR United Kingdom