Enterprise Architect - Manufacturing (Elkton)

Job Summary : The TMC Enterprise Architect will own the execution the IT strategy and roadmap that supports the enterprise vision and mission. In addition, the IT solutions will enable achievement of business goals and regulatory compliance in the design and manufacture of medical devices within the Manufacturing and Distribution Locations at TMC. This role works cross-functionally to drive technical change and cultural transition by automating processes intended to deploy our Factory of the Future.

Job Details :

1. Own and implement a strategic IT roadmap that aligns with the organizations prioritized business objectives and includes plans for existing and future IT solutions that deliver value realization.

2. Facilitate cross-functional roadmap review meetings to ensure changes in business prioritization are accurately reflected and roadmap stage gates and milestones are compatible with other business and IT objectives.

3. Establish and enforce enterprise-wide IT standards to promote the correct and consistent use of technologies within the organization.

4. Identify, assess, and mitigate potential risks associated with IT investments.

5. Analyze requirements, develop designs and production migration procedures and oversee the implementation of business applications and services.

6. Create a comprehensive plan and structured approach to implement end-to-end factory automation including machine integration that minimizes the number of Operator keystrokes and resulting human errors and increases throughput while ensuring electronic Device History Records (eDHR) meet quality standards and regulatory guidelines.

7. Lead the design and implementation of enterprise solutions such as ETQ Quality Management System (QMS) and a Laboratory Information Management System (LIMS) as well as related integrations.

8. Provide technical mentorship to developing IT members supporting ETQ and LIMS as well as Enterprise Resource Planning (ERP), Manufacturing Execution Systems (MES), Warehouse Management Systems (WMS), Continuous Monitoring Systems for Controlled Environments, Automated Storage & Retrieval Systems (ASRS), Automated Guided Vehicles (AGVs) in addition to their interfaces.

9. Provide specifications for the acquisition of tools, as needed.

10. Work with internal / external customers to solve technical challenges using industry best practices.

11. Design application architecture, including user interface and middleware; collaborate with the IT Infrastructure team.

12. Lead the creation and review of design documents and artifacts; facilitate code reviews.

13. Collaborate with key Stakeholders to ensure Architecture is aligned with Stakeholder requirements as well as Business Requirements.

14. Demonstrate application prototypes and integrate user feedback.

15. Oversee application maintenance, upgrades, and migration.

16. Document application development processes, procedures, and standards.

Position Requirements :

Knowledge, Skills and Abilities (KSAs) :

Takes accountability for results and drives project to the completion on time and within budget.

Proficient at developing and maintaining precise system documentation, guidelines, and presentations for management review.

Experience analyzing enterprise system performance using process improvement methodology.

Participates in development activities including code reviews, as well as coding and testing of new enhancements.

Proficient with MSWord, Excel and Power Point office applications.

Demonstrate and model effective listening, sound logical judgment, and organizational skills.

Excellent communication skills both verbal and written are required to partner with and update key stakeholders on a frequent basis.

Demonstrate strong knowledge of mathematics and statistical analysis.

Firsthand experience with physical and relational data models.

Demonstrate and model troubleshooting skills.

Knowledge of GAMP5 Methodology preferred but not required.

Knowledge of FDA process validations, including development of protocols and execution of protocols and GXP.

Ability to support end users remotely and locally and provide training and technical assistance when required.

Background Experiences

Minimum bachelors degree in computer science or it required, or equivalent combination of education and experience.

A minimum of ten (10) years experience supporting manufacturing systems including MES and integrations with ERP and other systems required.

A minimum of five (5) years experience as an IT Architect with experience designing, developing and implementing complex IT solutions that drive digital transformation in an FDA-regulated manufacturing industry (preferably medical device or pharmaceutical) supporting Supply Chain systems and designing GxP-compliant enterprise architecture including ERP, MES, QMS, LIMS and related integrations required.

A minimum five (5) years experience designing or supporting Data Lakes, Modeling, Warehousing and Governance preferred.

First-hand experience with SQL programming and performance tuning is required.

Advanced programming knowledge in .NET Technologies, C#, VB.NET, Java, MS SQL Database programming and Oracle programming is required.

Experience implementing scalable and flexible 3rd party integrations with a comfort level using APIs.