Job Description
We are seeking a highly skilled MES (Manufacturing Execution System) Engineer to join our team. The ideal candidate will have strong experience in pharmaceutical manufacturing environments and a deep understanding of GxP compliance. This role involves designing, implementing, and supporting MES solutions to optimize production processes, ensure regulatory compliance, and enhance operational efficiency.
Key Responsibilities:
style=”margin-top:0.0in;margin-bottom:0.0in” type=”disc”-
-Design and Configure MES Solutions: Develop and implement MES functionalities to support batch execution, electronic batch records (EBR), and production workflows.
-System Integration: Collaborate with automation, ERP, and IT teams to integrate MES with other systems (e.g., SAP, LIMS, SCADA).
-Compliance & Validation: Ensure MES systems comply with GxP, FDA 21 CFR Part 11, and other regulatory requirements. Prepare and execute validation protocols (IQ/OQ/PQ).
-Troubleshooting & Support: Provide technical support for MES applications, resolve issues, and maintain system reliability.
-Continuous Improvement: Identify opportunities to enhance MES performance and streamline manufacturing processes.
-Documentation: Maintain accurate system documentation, SOPs, and change control records.
Additional Information
style=”margin-top:0.0in;margin-bottom:0.0in” type=”disc”-
-Education: Bachelor’s degree in Engineering, Computer Science, or related field.
-Experience:
style=”margin-top:0.0in;margin-bottom:0.0in” type=”circle”-
-Minimum 3–5 years working with MES systems (e.g., Koerber PAS-X, Rockwell Syncade, or similar).
-Must have Koerber PAS-X experience
-Knowledge of Rockwell Pharmasuite, siemens Opcenter & Emerson Syncade is an advantage
-Strong background in pharmaceutical manufacturing and GxP compliance.
-Experience with system validation and regulatory audits.
style=”margin-top:0.0in;margin-bottom:0.0in” type=”disc”-
-Technical Skills:
style=”margin-top:0.0in;margin-bottom:0.0in” type=”circle”-
-Knowledge of SQL, scripting, and system configuration.
-Familiarity with integration to ERP and automation systems.
Preferred:
style=”margin-top:0.0in;margin-bottom:0.0in” type=”disc”-
-Experience with electronic batch records (EBR) implementation.
-Understanding of ISA-95 and ISA-88 standards.
-Previous involvement in MES deployment projects in regulated environments.
To help us track our recruitment effort, please indicate in your email/cover letter where (vacanciesineu.com) you saw this job posting.
Location: Basingstoke (RG24) - Hampshire, South East, United Kingdom Salary: Competitive Type: Permanent Main Industry:…
Location: Jefferson Parish, Louisiana, United Kingdom Salary: Competitive Type: Permanent Main Industry: Search Accountancy Jobs…
Location: South East, United Kingdom Salary: 40000.00 Type: Permanent Main Industry: Search Management & Executive…
Location: Sweden Salary: Competitive Type: Permanent Main Industry: Search Engineering Jobs Advertiser: Bentley Systems Job…
Location: Ormskirk (L40) - Lancashire, North West, United Kingdom Salary: Up to £23186.80 per annum…
Location: Swaffham (PE37) - Norfolk, East Anglia, United Kingdom Salary: Up to £25178.4 per annum…