Job Description

Validation Specialist

Greenville, North Carolina

Long Term Project

Note: No C2C

Key Responsibilities:

• Draft protocol templates, media fill summaries, and standardized reports.
• Populate bracketing documentation tables and support protocol generation.
• Maintain central trackers for protocol reviews, approvals, and interventions.
• Coordinate feedback cycles across site and global stakeholders and update documents accordingly.
• Provide day-to-day execution support to ensure project deliverables remain on schedule.
• Support documentation drafting and onsite coordination across Validation and QA functions.

Qualifications & Requirements:

• Bachelor’s degree in an industry-related field.
• Minimum of 5+ years of industry experience, including direct experience with Media Fill Validation .
• Demonstrated experience in Commissioning & Validation (C&V) activities .
• Experience authoring and executing protocols, drafting media fill summaries, and standardized reports.
• Experience working in a pharmaceutical or FDA-regulated manufacturing environment.
• Strong knowledge of cGMP and facility/equipment validation requirements.
• Excellent written and verbal communication skills with the ability to convey information clearly and persuasively.
• Ability to work effectively across all levels of the organization and in a cross-functional team environment.
• Strong problem-solving, critical thinking, and attention to detail.

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