Validation Expert Tz 50% - Stanardsville, VA, United States - Emerald Enterprises

Emerald Enterprises
Emerald Enterprises
Verified Company
Stanardsville, VA, United States

2 days ago

James Miller

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James Miller

beBee Recruiter
Freelance
Description

Are you interested in working as a Validation Expert for a global player in Stanardsville, VA? Our client is urgently seeking reinforcements: Validation Expert PT 50% - (m/f/d).


This position offers a hybrid work model, with the possibility to work 70% from home office/remote on a weekly basis or as needed.

The position is currently limited to 18 months with the option for extension.


Your responsibilities will include:


  • Coordinating, planning, and conducting validation of aseptic processes (media fills), hold times, and personnel qualifications
  • Creating, maintaining, and coordinating master validation plans, validation protocols/reports, risk analyses, regulations, and related deviations, change requests, and actions as needed
  • Evaluating and summarizing the results of planned studies
  • Assisting in the preparation of regulatory documents and responding to regulatory inquiries
  • Presenting complex technical topics in crossfunctional project teams/meetings with internal and external partners, as well as during audits and regulatory inspections
  • Collaborating with customers and interfaces while considering internal and global regulations, as well as legal and regulatory requirements
  • Planning, coordinating, and evaluating additional studies (internal/external) or assessments in collaboration with the supervisor
  • Planning and coordinating technical topics within the team and contributing to global topics within the company group

Requirements:


  • Master's degree in a scientific or technical field with several years of professional experience, as well as several years of experience in process validation
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