Position summary:  

Accountable for MES platform governance, to ensure MES systems are in line with industry best practice. This role will lead the design and build for enhancements and releases to ensure regulatory and other business critical requirements are met with existing MES deployments.  The role will also include deep understanding of upstream and downstream systems to ensure end to end service meets expectations. 

This role will act as a technical and architectural bridge between managed service partner and IS Build teams in the MES space. 

Accountable for service excellence throughout the service lifecycle for assigned category of services.    The scope of work includes oversight of service design activities during projects (i.e., create/evolve stages), SDLC/ALM practices, a robust governance model (i.e., data policies, vendor management, KPIs, SLAs, etc.), operational and quality management procedures, and routine reviews with business service owners and/or stakeholders.  Additionally, recruitment, selection, and retainment of a highly engaged team is a focal responsibility.  Success is determined by customer feedback and achievement of KPI targets in the areas of service availability, quality, performance, efficiency/cost. 

The IT Service Technical Lead is the primary point of accountability for management and delivery of quality service for the MES platforms. 

The role will develop the processes to ensure the MES platform, Apriso Core in particular is governed effectively to ensure scalability to meet the needs of Stryker. This includes developing and implementing an Instance Management Strategy, ensuring good management of Source code, Source Code reviews and well documented code process and adherence.  

Essential duties & responsibilities: (detailed description) 

​​​Operations 

• ​Proactively develop customer relationships; anticipate and provide solutions to customer needs giving high priority to customer satisfaction 

• ​Architect and lead the implementation of Manufacturing Execution System (MES) and system integration solutions projects 

• ​Leads continuous improvement initiatives to mature operations and increase visibility into service performance. 

• ​Plan and organize the work of enhancements, develop the implementation strategies, act as a mentor for individuals within the group, and resolve issues. 

• ​Develop detailed designs, implement, troubleshoot and test MES solutions that meet user requirements following Quality Management Standards 

• ​Develop documentation including creation of test scripts required for validated facilities. 

• ​Develop and improve processes, procedures and tools used in the execution of projects. 

• ​Act as a liaison between the internal project team, internal management, sales and customer project teams and management 

​Governance  

• ​Ensure technical governance of the MES portfolio 

• ​Ensure Instance Mgt strategy is fit for purpose 

• ​Ensure platform is scalable and configured to meet growing customer numbers 

​Business Skills 

• ​Advises on the available standards, methods, tools and applications relevant to own area of service and can make appropriate choices from alternatives.  

• ​Takes customer requirements into account when making proposals.  Analyses requirements and advises on scope and options for continuous operational improvement. Demonstrates creativity and innovation in applying solutions for the benefit of the client/stakeholder. 

• ​Analyses, designs, plans, executes and evaluates work to time, cost and quality targets.  

• ​Assesses and manages risk.  

• ​Communicates effectively, both formally and informally.  

• ​Facilitates collaboration between stakeholders who have diverse objectives.  

• ​Takes initiative to maintain skills and awareness of developments in the industry.  

• ​Mentors colleagues.  

​Project intervention 

• ​Maintain awareness of pending and active projects that may or will impact Manufacturing Automation team or services. 

• ​Lead the design phase in coordination for any Build team driven projects. 

• ​Ensuring the RUN team oriented projects are aligned per the Build Team & Enterprise Architect asks. 

• ​Champion service and support preparation and initialization in projects.  Push for quick adoption of project execution strategies that produce highly maintainable services with low TCO.  This includes: 

• ​Ensuring a robust SDLC is followed (see SDLC) 

• ​Critical documentation is made available, maintained, and made accessible to pertinent audiences 

• ​Support and maintenance tools and resources are budgeted and provisioned/acquired 

• ​A priority is placed on targeting self-service and service desk as fulfillment options for support activities where possible 

• ​Routine maintenance activities are minimized or automated 

• ​Minimize build-to-run transition by ensuring a customer experience centered approach to the service design and delivery. 

​SDLC  

• ​Ensure requirements and test scripts are clearly documented in clear, meaningful language, well organized for continuous maintenance for the life of the service, and accessible by relevant support resources. 

• ​Ensure source code and other solution artifacts are stored in a versioned repository. 

• ​Ensure design and code reviews are executed to confirm adherence to quality standards. 

• ​Ensure due consideration is given to implement automated build, deployment, and test activities.  Where automation is not tenable, ensure justification is documented with any plans and timelines to remediate.​​ 

Education & special trainings: 

• Bachelor's Degree from an accredited university required; Bachelor’s degree in the areas of Computer Science, Software Engineering, Information Systems, Business, or equivalent field of study preferred.  

• ITIL Foundations v4 certification preferred 

• MES project implementation experience in the batch process industry including workflows, equipment management and materials management 

• Excellent understanding of APRISO functionalities and other MES systems 

• Excellent understanding of Computer Systems Validation, GMP and 21 CFR Part 11 

• Must have the demonstrated ability to work in a team environment as both a leader and an individual contributor 

• Experience in APRISO product development is desirable 

• Ability to quickly establish good working relationships with others from all levels 

• Experience with SDLC (Waterfall/Agile) 

• Experience working with customers to create user requirement/functional specification 

Qualifications & experience: 

• At least 3 years of experience in MES projects.  

• MES project implementation experience in a Life Sciences including workflows, equipment management and materials management. 

• Proven experience of MES project design (including high-level front-end design, functional design and detailed design). 

• Proven experience with MES project execution (requirements analysis, design definition, design review, software development and review, solution implementation, testing and acceptance, traceability). 

• Knowledge of ERP (including integration with SAP) a plus. 

• Knowledge of active directory, DNS, IP networks and virtualization is a plus. 

• Strong communication and relationship skills. 

• Knowledgeable in FDA validation requirements including: User Requirement and Design Specs, Business Process Procedures, Design Reviews, Requirements gathering.  

• Strong experience of data migrations and thorough understanding of Apriso data models 

• Experience in MES technical management is a must 

• Strong critical thinking / problem solving skills  

• Demonstrated experience in service operations and service delivery (build) teams.  

Physical & mental requirements:  

• ​​Ability to lead on and off-shore technical teams in a matrixed organization.  

• ​Self-motivated and organized with a strong desire to succeed 

• ​Excellent oral and written communication skills.  

• ​Excellent problem solving and risk mitigation skills 

• ​Autonomy: Works under broad direction. Work is often self-initiated. Is fully accountable for meeting allocated technical and/or project/supervisory objectives. Establishes milestones and has a significant role in the delegation of responsibilities.  

• ​Influence: Influences organization, clients, suppliers, partners and peers on the contribution of own specialism. Builds appropriate and effective business relationships. Makes decisions which impact the success of assigned projects i.e. results, deadlines and budget. Has significant influence over the allocation and management of resources appropriate to given assignments. 

• ​Complexity: Performs an extensive range and variety of complex technical and/or professional work activities. Undertakes work which requires the application of fundamental principles in a wide and often unpredictable range of contexts. Understands the relationship between own specialism and wider client/organizational requirements.​