Technical Lead

· Extensive knowledge and experience of delivering GMP Process Control Systems (PCS) as part of major Pharmaceutical/Biotech investments. Domain Expertise in DCS, SCADA, PLCs applications within a licensed GMP environment focusing on specification, procurement, installation, start-up, and commissioning.

· Strong understanding of both Biotech and API manufacturing processes.

· Drug Product automation experience of vial filling and packaging lines an advantage; including specification, delivery, and data integration.

· Understanding of the needs of the post-project operational environment.

· Bachelor's degree (equivalent experience will be considered) in an Engineering or IT related field.

· Excellent interpersonal skills including an ability to engage honestly and influentially with internal and external business leaders and partners.

· Demonstrated Project Management skills.

· Broad understanding of secure integration of PCS to:

· IT architectures

· Recipe data to support efficient Tech Transfer

· Manufacturing Execution Systems (MES)

· Process Historians

· Factory data-analytics platforms

· Process Analytical Technology (PAT)

· Proficient in English

· IT architectures

· Manufacturing Execution Systems (MES)

· Process Historians

· Factory data-analytics platforms

· Process Analytical Technology (PAT)

· Current GMP regulations and an understanding of regulatory agency expectations and current industry practices.

· Supporting technologies:

· OT cybersecurity

· Electronic Batch Records (EBR)

· Data modeling and analytics

· Laboratory automation systems

· Warehouse automation and automated materials handling

· Supporting technologies:

· OT cybersecurity

· Electronic Batch Records (EBR)

· Data modeling and analytics

· Laboratory automation systems

· Proficient in English

Job Title: Automation Lead

Introduction to role

Are you ready to own the charge in digital transformation and smart manufacturing? As an Automation Lead SME based in Boxmeer, you'll orchestrate the design and delivery of pioneering Operational Technology solutions for major engineering projects. This pivotal role involves driving Industry 4.0 innovations and ensuring alignment with our global automation strategy. Candidates with strong automation skills in GMP settings and shown leadership abilities can **influence** the future of manufacturing at a leading biopharma firm.

Accountabilities

Define Operational Technology (OT) scope within Global Engineering projects:

· Collaborate with site and project partners to ensure alignment with project scope

· Formulate OT strategy and secure approval from project collaborators

· Provide technical leadership and design assurance during capital project design, from concept through detailed design and equipment selection

· Communicate site and project requirements to vendors

· Ensure systems are specified and delivered in alignment with Merck's global automation strategy

· Drive digital transformation by implementing Industry 4.0 technologies to establish Smart Factories and Autonomous Manufacturing

· Engage with colleagues in Global IT/OT to set standards, develop technology strategy, and ensure alignment

· Work optimally with local and internationally located peer engineers to deliver complex projects as a team

Establish strong and positive partnerships with:

· Project Managers, Project Technical Managers, and Work Package Owners during all phases of projects to supervise the flow of information between vendors, contractors, and internal resources to deliver design intent and meet quality standards

· Site Manufacturing Operations and Quality teams to ensure quality and security of supply to our patients

· Site IT and Operations-IT to ensure systems and data integration meets Autonomous Manufacturing requirements

Job Title: Automation Lead

Introduction to role

Accountabilities