MedTech Systems Implementation Lead & Project Manager

Antler Co; Raritan (NJ); Hybrid; USD 109,000 - 175,000; Full time

Benefits offered by this job

Vacation –120 hours/year

Sick time – 40 hours/year

Holiday pay

Job summary

Johnson & Johnson MedTech seeks a Systems Implementation Lead & Project Manager in Raritan, NJ, to steer R&D data initiatives with 3 days on-site. You’ll drive automated data solutions, CSV validation, and cross-functional collaboration across scientific teams worldwide.

Requires 5+ years in regulated environments, strong knowledge of 21 CFR Part 11, and experience with Agile/Waterfall PM. Hybrid work schedule with on-site presence in NJ is offered.

Qualifications

• Bachelor’s degree in a quantitative field required; Master’s preferred.
• 5+ years in regulated environments (pharma/medical device) for GxP computerized systems.
• Experience with Agile and waterfall project management.
• Knowledge of data integrity concepts and electronic records/e-signatures.

Responsibilities

• Lead data science projects and manage cross-functional teams.
• Develop validation plans and traceability for CSV & QA activities.
• Plan and execute risk-based validation for GxP systems.
• Design test cases across SDLC phases and ensure traceability.
• Mentor junior data scientists and promote best practices.

Skills

GxP data systems knowledge

Agile project management

Cross-functional leadership

Data science / analytics

Communication excellence

Matrix environment experience

Education

Bachelor’s degree in engineering or related quantitative field

Master’s degree preferred

Tools

SAP Product Lifecycle Management

21 CFR Part 11 knowledge

Job description

Johnson & Johnson MedTech seeks a Systems Implementation Lead & Project Manager in Raritan, NJ, to steer R&D data initiatives with 3 days on-site. You’ll drive automated data solutions, CSV validation, and cross-functional collaboration across scientific teams worldwide.

Requires 5+ years in regulated environments, strong knowledge of 21 CFR Part 11, and experience with Agile/Waterfall PM. Hybrid work schedule with on-site presence in NJ is offered.