CSV Engineer

Indianapolis, IN, US • Posted 60+ days ago • Updated 7 hours ago

Full Time

On-site

Fitment

Dice Job Match Score™

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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

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