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IT Architect - Manufacturing Execution Systems (MES)/Digital Execution System

Lebanon, IN · $123,000 to $180,400
OPEN JOB: IT Architect - Manufacturing Execution Systems (MES)/Digital Execution System
LOCATION: Lebanon, Indiana
***4 days a week on-site, 1 day a week remote.

***Relocation Assistance Available
SALARY: $123,000 to $180,400
BONUS ELIGIBLE
FULL-TIME
FULL BENEFITS
INDUSTRY: PHARMACEUTICAL / BIOTECH
JOB CATEGORY: Information Technology - System Development


Our client is entering an exciting period of growth, and we are committed to delivering innovative medicines to patients around the world. The company's research tech has a growing need for in-house manufacturing of material for clinical supplies and will therefore construct a new campus to manufacture Clinical Trial (CT) Active Pharmaceutical Ingredient (API). This new facility will meet the needs for a rapidly growing portfolio (more and new areas), to accelerate development timelines, and to improve supply chain strength. The brand-new facility, also known as the company, will utilize the latest technology to augment the current clinical supply chain for small molecules (SM), oligonucleotides, peptides, and Antibody Drug Conjugates (ADCs), monoclonal antibodies and bioconjugates, and add new capabilities including mRNA. This new site will be built using the latest high-tech equipment, sophisticated highly coordinated and automated manufacturing systems, and have a focus on minimizing the impact to our environment.

What You’ll Be Doing:
  • As the Senior Technical Architect for Manufacturing Execution Systems (MES), your main responsibility will be to craft and develop robust IT architecture solutions tailored to sophisticated business challenges within the pharmaceutical manufacturing domain. This role demands a deep technical expertise in creating integrated process, application, data, and technology architectures, ensuring conformity with enterprise standards and strategic goals.
  • You will lead the implementation of complex MES, driving the transition to paperless execution from the facility's inception. Your role will involve deploying innovative technologies, ensuring seamless integration with existing systems, and collaborating multi-functionally to uphold the Manufacturing Strategy for Operational Excellence. You will be instrumental in delivering IT solutions that meet exacting quality standards and facilitate the site’s mission and vision.

How You Will Succeed: 
  • Bring your deep technical knowledge and experience to design and develop product architecture for MES and Digital Execution solutions.
  • Must ensure the compatibility, integration, interoperability, stability, scalability and usability of products/services proposed as standards to ensure an integrated architecture across interdependent technologies.
  • Must serve as a technical expert on solutions design, development, and implementation requirements to address business needs.
  • Must consider security, privacy and data integrity risks and design IT systems that are secure and protect company data and ensure compliance.
  • Possess the capability to communicate sophisticated technical information to both technical and non-technical partners and influence decision making at senior leadership level.
  • Develop an in-depth understanding of the business processes at LMF. Apply knowledge to assigned solutions to support the operational workflow. Work with Process Engineers, Operations, Quality, and Scientists to resolve any issues reported on the solutions implemented.
  • Drive the site adoption of assigned solutions, ensuring consistency with Site and IT strategy, and using awareness of internal and external trends in collaboration with the Business SMEs.
  • Collaborate with developers and subject authorities (global and local) to establish the technical vision and analyze trade-offs between usability and performance needs.
  • Review and approve documentation related to areas of responsibility (Validation Lifecycle documents, SOPs, policies, implemented IQPQ protocols, etc.) as appropriate.

What You Should Bring:
  • Experience with designing and developing IT architecture (integrated process, applications, data and technology) and solutions to business problems in alignment with the enterprise architecture direction and standards.
  • Experience leading or supporting the Computer System Validation of IT platforms including Data Integrity compliance.
  • Experience with identifying system requirements, such as performance, scalability, security, compatibility, interoperability, stability, usability, data integrity and ensure that these requirements are met within the overall system architecture.
  • Experience with providing technical guidance to other members of the organization, including developers, project managers, and technical support staff.
  • Staying up to date with industry trends and emerging technologies to ensure that the organization's systems remain innovative and effective.
  • Superb communication and people skills to build relationships with team members and articulate sophisticated technical concepts.
  • Adaptability and flexibility to work in a fast-paced, dynamic environment and lead multiple tasks simultaneously.
  • Extensive background with MES and how to integrate with Automation, Lab and other Local/Global IT platforms.
  • Consistent track record in tools / platforms such as MES Syncade, PharmaSuite, Pas-X, Tulip or similar and Integration technologies enabling data flow with downstream and upstream systems (e.g. SAP, LIMS, DeltaV, MQTT, UNS, Aveva PI, Data Lakes, Process Monitoring systems such as JMP, Tableau, Power BI or similar)
  • Demonstrable experience in platform practices and procedures such as infrastructure qualification, patching, monitoring, log analysis, edge computing, site reliability engineering, or disaster recovery.
  • Demonstrable experience in languages, tools and concepts such as Python, JSON, YAML, SQL, or Git, Github, C#, SQL, XML, REST, OPCUA, Data Modeling, Web Development, Cloud first architecture
  • Develop or update project plans including the determination of project activities and achievements. Provided oversight of multiple project and communications status.

QUALIFICATIONS: 
  • Bachelor’s degree in software engineering, Computer Science, Computer Engineering, or a related field.
  • Minimum of 3+ years of experience working with Pharmaceutical Manufacturing Execution Systems (e.g. Data solutions, MES technologies such as Rockwell Automation Pharma Suite, Emerson Syncade, Siemens Camstar, or Werum PAS-X).
  • Minimum of 3+years of experience on Active Pharmaceutical Ingredients (API) manufacturing facilities.

Additional Information:
  • This position will be on site 4 days a week
  • Potential to work after hours
  • Actual compensation will depend on a candidate’s education, experience, skills, and geographic location.


If you are interested in pursuing this opportunity, please respond back and include the following:
 
  • MS WORD Resume
  • required compensation.
  • Contact information.
  • Availability
 
Upon receipt, one of our managers will contact you to discuss the position in full detail.

Jason Denmark
Recruiting Manager

INTERMEDIA GROUP, INC.
EMAIL: jdenmark@intermediagroup.com
LINKEDIN: https://www.linkedin.com/in/jasondenmark/

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