Application Lead MES LIMS

About Pharming Group N.V.
Pharming Group N.V. (EURONEXT Amsterdam: PHARM/Nasdaq: PHAR) is a global biopharmaceutical company dedicated to transforming the lives of patients with rare, debilitating, and life-threatening diseases. Pharming is commercializing and developing an innovative portfolio of protein replacement therapies and precision medicines, including small molecules and biologics. Pharming is headquartered in Leiden, the Netherlands, and has employees around the globe who serve patients in over 30 markets in North America, Europe, the Middle East, Africa, and Asia-Pacific.

Our Culture 
Pharming is committed to our core values: “We Care, We Collaborate, We Walk the Talk”, which is complementary to our focus on self-development of our people, teamwork, leadership and being results orientated. In our growing organization, it is important that employees feel connected and engaged.  Our core values enable our mission of bringing the unserved rare disease patients the solutions they need and create a clear pathway forward to meet our strategic goals and objectives.

Purpose of the job:
The Application Lead MES LIMS will be responsible for leading assigned initiatives across IT, including applications related to the MES (Manufacturing Execution System) and LIMS (Laboratory Information Management System) areas. The role includes overseeing the entire project lifecycle—from planning, requirements gathering, design, testing, implementation, and ongoing support.

You will work closely with business stakeholders, external partners, and cross-functional teams to align business needs with technical solutions. This will involve managing software solutions that enhance operational efficiency and support production goals within the pharmaceutical manufacturing and laboratory environment.

A critical part of the role is to shape and execute a multi-year roadmap for IT applications in the MES and LIMS platform space. This roadmap will be developed in alignment with business objectives and priorities, ensuring that the technology solutions evolve to meet the company’s strategic goals over time.

Key Responsibilities:

• System Ownership & Project Leadership: Lead the deployment, customization, and ongoing support of MES and LIMS systems, ensuring seamless integration and operation across manufacturing and laboratory environments.
• Application Management: Oversee software solutions for manufacturing (MES) and laboratory (LIMS) processes, driving improvements that meet both functional and non-functional requirements.
• Requirements Gathering & Analysis: Engage with stakeholders to identify business needs, analyze existing processes, and document detailed functional and technical requirements. Collaborate with external partners to translate business needs into solutions.
• Solution Design: Work closely with technical teams of our suppliers and system integrators to design solutions that align with business goals and objectives. Ensure solutions support operational efficiency, regulatory compliance, and quality standards.
• ISA-88 & ISA-95 Implementation: Leverage ISA-88 (Batch Control) and ISA-95 (Enterprise-Control System Integration) standards to configure MES systems effectively for batch manufacturing and optimize integration between enterprise and control systems.
• IT/OT Integration: Ensure seamless integration between IT and OT systems, facilitating smooth communication between manufacturing and IT teams. Works closely with IT operations, IT architects, and IT security.
• Shaping the IT Application Roadmap: Shape and define a multi-year roadmap for MES and LIMS applications, ensuring it is aligned with the business strategy and evolving operational needs. Lead regular reviews and updates to ensure continuous alignment with both business priorities and technological advancements.
• Testing & Validation: Manage the development of test cases, coordinate with QA teams, and support user acceptance testing (UAT). Ensure systems meet business requirements and regulatory standards
• Process Improvement: Lead workshops and meetings to brainstorm process improvements. Apply Lean and Six Sigma methodologies to propose and implement enhancements to existing systems and workflows.
• Stakeholder Communication: Act as a liaison between business stakeholders, IT teams, and external partners, ensuring smooth communication and progress reporting.
• Documentation: Create and maintain comprehensive documentation, including requirements, user stories, process flows, and test cases. Ensure clarity and accessibility for stakeholders and development teams.
• Training & Support: Provide ongoing support, training, and guidance to users of MES (e.g. iVention) and LIMS systems, assisting them in maximizing system efficiency.
• Project Management: Support project management activities such as timeline and resource planning. Assist with the rollout of new software tools and change management initiatives.
  
  Qualifications:
  
• Education: Bachelor’s degree in Computer Science, Engineering, Information Technology, Business Administration, or a related field. Master’s degree preferred.
  
  Experience: 
• Minimum 5-7 years of experience in business analysis or similar roles in an IT environment, particularly with MES (e.g., iVention) and LIMS systems.
• Proven experience in gathering, documenting, and analyzing business requirements.
• Strong experience in liaising between business and IT teams, ensuring effective communication and collaboration.
• Familiarity with MES and LIMS systems within the pharmaceutical industry is highly desirable.
• Experience with ISA-88 (Batch Control), ISA-95 (Enterprise-Control System Integration), IT/OT integration, and regulatory compliance in manufacturing processes.
• Familiarity with GxP, GAMP 5, and Pharmaceutical Validation (V-Model) is a plus.
•  Strong preference for Dutch native speakers to communicate effectively with local teams in the Netherlands.

   
Technical Skills:

• Expertise in MES and LIMS systems.
• Proficient in SQL, API design, data flow mapping, and troubleshooting.
• Understanding of Lean and Six Sigma methodologies for process improvement.
  
  

What you'll get in return
We offer you a permanent position (starting with a one-year contract), with an excellent remuneration scheme, including:

• A highly competitive salary
• 8.33% holiday allowance (for NL)
• A minimum of 30 vacation days
• An excellent pension plan
• Commuting allowance

You will also join our Learning & Development program, which can offer a tailor made development plan, based on your personal and professional needs. Learning opportunities are everywhere, in all forms imaginable and we want to create learning memories for all “Pharmers”.

Also important! We truly value a healthy life-work balance with a lot of flexibility.

Apply for the job
Does this sound like you and do you want to join our team? Then we'd love to hear from you!

We’re an equal opportunity employer. All applicants will be considered for employment without attention to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran or disability status.