Validation Documentation Specialist
Job Title: Validation Documentation Specialist
Location: Holly Springs, NC (Onsite)
Experience: 5 10 years
Duration: 12+ Months Contract
Job Overview:
Our Pharma partner provides end-to-end solutions for drug development and manufacturing, specializing in biologics, advanced therapies, and vaccines. They support programs from preclinical development through commercial manufacturing.
Position Overview:
We are seeking a CQV Document Control Specialist to support documentation, protocol writing, and report closeouts in compliance with Pharma GMP standards. This role requires strong attention to detail, excellent writing skills, and the ability to manage multiple projects within a small team.
Key Responsibilities:
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Assist in writing, reviewing, and maintaining protocols and related documentation.
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Execute and closeout validation and engineering reports.
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Manage deviations and ensure proper documentation closure.
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Collaborate effectively with team members and other departments.
Qualifications:
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5 10 years of experience in Validation or Engineering within the pharmaceutical industry.
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Strong understanding of Pharma GMP standards.
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Proven skills in documentation, report writing, execution, and closeouts.
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Willingness to learn and work closely within a small team environment.
Preferred Skills (Nice to Have):
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Experience with Capital Projects or large-scale fill-line operations.
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Excellent communication and teamwork skills.
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Ability to switch between multiple projects efficiently.
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