MES Interface SME ? Portsmouth, NH
This is an office-first role based on site in Portsmouth, NH. Working together in person supports close, real-time collaboration and team alignment, enabling us to deliver our best work. You will work primarily in the office and laboratory settings, with the flexibility to work remotely for 20% of your time (one day per week).
What you will get:
Compensation for this role will be determined by the candidate?s qualifications, skills, experience, and relevant knowledge.
What you will do:
Lead gLIMS?MES interface validation activities to ensure on-time delivery and full compliance of all validation documentation.
Collaborate with the Site Change Manager and Automation SME to update or replace local MES/LIMS SOPs in alignment with global quality standards.
Partner with gLIMS/MES leads, system users, and process owners to design, revise, and configure production recipes supporting system interfacing.
Execute and oversee test scripts (design, execution, and simulation) with guidance from validation leads and supervisors.
Ensure all integration, requirements gathering, and testing procedures strictly meet regulatory, cGMP, and quality standards.
Utilize quality systems (such as TrackWise) to manage deviations, change controls, CAPAs, and system updates.
Interface across cross-functional groups including Quality, Manufacturing Operations, and the global gLIMS project team.
What we are looking for:
Bachelor of Science degree in an applicable STEM field or Computer Science with relevant industry experience required.
5?10 years of advanced experience in Automation, Quality Control, or Validation within a cGMP Pharma/Biotech environment.
Deep technical proficiency in MES and LIMS integration, along with strong knowledge of Lonza?s Computer System Validation (CSV) guidelines and SOPs.
Proven project management skills with the ability to lead validation streams, organize resources, and control project timelines.
Excellent cross-functional communication skills and proficiency with tools such as MS Project, Excel, Word, and PowerPoint.
Strong decision-making, problem-solving, and analytical capabilities in handling complex automated systems.
About Lonza
At Lonza, their people are their greatest strength. With 30+ sites across five continents, their globally connected teams work together every day to manufacture the medicines of tomorrow. Their core values of Collaboration, Accountability, Excellence, Passion and Integrity reflect who they are and how they work together. Everyone?s ideas, big or small, have the potential to improve millions of lives, and that?s the kind of work they want you to be part of.
Innovation thrives when people from all backgrounds bring their unique perspectives to the table. At Lonza, they value diversity and are committed to creating an inclusive environment.
As Lonza?s talent acquisition partner, please note, Randstad is responsible for the engagement and contracting of this contingent role.
Ready to play your part in shaping the future of life sciences? Apply now.
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