CSV Engineer

Indianapolis, IN, US • Posted 30+ days ago • Updated 52 minutes ago
Full Time
On-site
Fitment

Dice Job Match Score™

🔢 Crunching numbers...

Job Details

Skills

  • Customer Facing
  • Regulatory Compliance
  • Computerized System Validation
  • Pharmaceutics
  • Quality Assurance
  • Quality Control
  • Manufacturing
  • Communication
  • English
  • Technical Writing
  • Microsoft Office
  • Adobe
  • Documentation
  • Risk Management
  • Evaluation
  • Auditing
  • Virtual Team
  • Cloud Computing

Summary

Roles & Responsibilities:
  • Play a client facing Compliance Lead role in projects, programs, and support work.
  • Provide consulting and guidance on quality and compliance needs to IT project teams and enable them to achieve compliance using a risk-based right-sizing approach.
  • Take ownership of assigned project/program/support responsibilities and deliver to committed timelines.
  • Meet quality expectations as per defined contractual obligations to the client.
  • Monitor, guide and drive off-site teams to achieve defined milestones and key objectives.
  • Always ensure external and internal process compliance of the team
Education & Experience:
  • Minimum of 5 years' experience as a Computer System Validation Consultant in a regulated environment (preferably Pharma) and must have played a lead role (able to work independently with minimal guidance).
  • Worked in a Pharmaceutical company as QA/QC within manufacturing area.
  • Good understanding of industry regulations (FDA and other regulatory agencies world-wide) Excellent communication skills with strong command over written and spoken English.
  • Technical Writing experience and expertise with relevant tools (MS Office Suite, Adobe documentation Suite) Desired Risk Management, Supplier evaluation and assessment and auditing experience is highly desirable.
  • Experience of working in virtual teams across different cultures and geographies Experience of working with cloud-based technologies is desired
Employers have access to artificial intelligence language tools (“AI”) that help generate and enhance job descriptions and AI may have been used to create this description. The position description has been reviewed for accuracy and Dice believes it to correctly reflect the job opportunity.
  • Dice Id: 91116760
  • Position Id: ca6bf5c2418f11009a6f88105b4ae7d0
  • Posted 30+ days ago
Create job alert
Set job alertNever miss an opportunity! Create an alert based on the job you applied for.

Similar Jobs

Lebanon, Indiana

Today

Full-time

USD 66,000.00 per year

Blue Ash, Ohio

Today

Full-time

Indianapolis, Indiana

Today

Full-time

Pittsburgh, Pennsylvania

Today

Full-time

Search all similar jobs