Validation Specialist
Humacao, PR, US
Engineering
Bachelors Degree
Full Time, Temporary
25
Experienced (Non-Manager)
On-site
Biotechnology/Pharmaceuticals
First Shift (Day)
Humacao, PR, US
25
Experienced (Non-Manager)
Full Time, Temporary
Biotechnology/Pharmaceuticals
On-site
Engineering
Bachelors Degree
First Shift (Day)
Job details
The Validation Specialist is responsible for planning, executing, and documenting qualification and validation activities to ensure that equipment, systems, utilities, and processes meet regulatory requirements and industry standards.
Develop and execute validation protocols (IQ/OQ/PQ) for equipment, systems, and processes.
Author, review, and approve validation documentation including protocols, reports, and SOPs.
Perform risk assessments and gap analyses on systems, processes, or equipment.
Coordinate validation activities with cross-functional teams (engineering, manufacturing, quality, etc.).
Requirements:
Bachelor’s degree in engineering, Sciences, or a related field (required).
2+ years’ experience in validation within the pharmaceutical, biotechnology, or medical device industry (preferred).
Strong knowledge of current Good Manufacturing Practices (cGMP) and regulatory guidelines.
Experience with validation life cycle, documentation, and project management.
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