Sr. Techno-Functional Consultant

Posted 5 Days Ago
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Parsippany-Troy Hills Township, NJ, USA
In-Office
100K-140K Annually
Senior level
Design
The Role
Leads techno-functional delivery for pharmaceutical and life sciences manufacturing integrations. Translates business requirements into technical designs for OEE, Connected Worker, and Golden Batch use cases; coordinates integration workstreams, stakeholders, risks, project plans, UAT, and validation. Owns technical documentation, data flows, implementation traceability, and platform governance while ensuring alignment with GxP, CSV, FDA, and EU regulatory requirements.
Summary Generated by Built In

We are unable to sponsor or take over sponsorship of an employment visa at this time.

 

Cross-Functional Coordination

  • This role requires active cross-functional coordination with business teams to ensure priorities, use case definitions, and acceptance criteria are aligned with the technical delivery roadmap.

Key Responsibilities

  • Translate business requirements into detailed technical specifications and solution designs for OEE, Connected Worker, and Golden Batch use cases
  • Lead and coordinate the integration workstream end-to-end; drive delivery ownership and escalation
  • Act as the primary point of contact for cross-functional stakeholders; facilitate alignment sessions across business, technical, and integration teams
  • Own technical design documents, integration specifications, and data flow diagrams
  • Govern risks/issues, project plan; represent GMSx in steering ceremonies and SAFe ceremonies
  • Drive cross-functional coordination with business teams to align priorities with technical delivery
  • Define technical implementation steps and ensure traceability between business needs and technical deliverables
  • Support UAT planning and coordinate with business stakeholders for validation
  • Provide guidance on best practices for MDF platform utilization within the GMSx program

Required Qualifications & Experience

  • 8+ years of experience in techno-functional roles within manufacturing, pharmaceutical, or life sciences domains
  • Proven track record of leading OT/IT integration projects and converting complex business requirements into technical solutions
  • Deep understanding of OEE calculations, batch processing workflows, and connected worker concepts in a manufacturing context
  • Strong project management skills — ability to plan, prioritize, and drive delivery independently across multiple workstreams
  • Experience guiding Computer System Validation (CSV) for Edge Gateway or similar integration platforms, preferably in GxP environments
  • Familiarity with GxP-regulated environments and relevant regulatory frameworks (FDA 21 CFR Part 11, EU Annex 11)
  • Solid understanding of data management principles (data flows, naming conventions, data governance)
  • Excellent stakeholder management and communication skills — ability to align global and local teams with different priorities
  • Experience with MES (e.g., PAS-X), MDF, or similar manufacturing data/execution platforms

Preferred / Nice-to-Have

  • Experience with SAFe Agile methodology in enterprise settings
  • Familiarity with ISA-95 / ISA-88 standards for manufacturing integration
  • Prior experience with large pharma/life sciences organizations
  • Knowledge of UNS (Unified Namespace) strategy and enterprise data governance frameworks

Kaleidoscope, an Infosys Company, is an equal opportunity employer, and all qualified applicants will receive consideration without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, spouse of protected veteran, or disability.

 

Skills Required

  • 8+ years of experience in techno-functional roles within manufacturing, pharmaceutical, or life sciences domains
  • Experience leading OT/IT integration projects and converting complex business requirements into technical solutions
  • Deep understanding of OEE calculations, batch processing workflows, and connected worker concepts in manufacturing
  • Strong project management skills, including planning, prioritization, and independent delivery across multiple workstreams
  • Experience guiding Computer System Validation for Edge Gateway or similar integration platforms, preferably in GxP environments
  • Familiarity with GxP-regulated environments and FDA 21 CFR Part 11 and EU Annex 11
  • Understanding of data management principles, including data flows, naming conventions, and data governance
  • Excellent stakeholder management and communication skills across global and local teams
  • Experience with MES, such as PAS-X, MDF, or similar manufacturing data and execution platforms
  • Experience with SAFe Agile methodology in enterprise settings
  • Familiarity with ISA-95 and ISA-88 manufacturing integration standards
  • Experience with large pharmaceutical or life sciences organizations
  • Knowledge of Unified Namespace strategy and enterprise data governance frameworks
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The Company
HQ: Cincinnati, OH
347 Employees
Year Founded: 1989

What We Do

When clients come to us for product design and development, they get a full range of technical expertise and laboratory resources, but they also get a team that’s relentless when it comes to solving problems and creating designs that are the ideal combination of function and form. What does that mean? We build tools that save lives. For surgeons, it means they have tools that not only address but anticipate their needs, which helps improve their patients’ outcomes. We create products that save money and ensure safety. For people juggling family, work, and other demands, it means they have products that provide real help in managing their everyday lives. And for businesses, it means their bottom line is supported with durable tools that improve efficiency and protect their teams. From concept to production plan, or at any phase in between, we are a partner that can extend your product development know-how or provide additional mindpower to free up in-house teams.

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