Validation Engineer
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
Job Purpose:
- Plan, execute, and document qualification and validation activities to ensure equipment, systems, utilities, and processes comply with regulatory requirements and industry standards.
Key Responsibilities:
- 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.).
- Ensure compliance with current Good Manufacturing Practices (cGMP) and regulatory guidelines.
- Support change control processes and evaluate the impact of proposed changes on validation.
- Maintain validation master plans and schedules for ongoing compliance.
- Participate in audits and regulatory inspections.
- Train and support personnel on validation procedures and requirements.
Qualifications:
- Bachelor’s degree in engineering.
- 2+ years’ experience in validation in the pharmaceutical, biotechnology, or medical device industry (preferred).
- Strong knowledge of cGMP and regulatory standards (FDA, ISO, etc.).
- Experience with the validation life cycle, documentation, and project management.
- Strong analytical, communication, and organizational skills.
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