Validation Analyst
Validation Analyst
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Salary Not Disclosed
1 Vacancy
Job Description
Encora is seeking a Validation Analyst to join us in a 100 remote role supporting EST work hours. This is a 6 month project.
Duties and Responsibilities:
- Develop and execute validation protocols (IQ OQ PQ) for equipment systems or processes.
- Perform risk assessments and define validation strategies based on system impact.
- Document validation activities in accordance with regulatory standards (e.g. FDA EMA GxP 21 CFR Part 11.
- Collaborate with crossfunctional teams (QA IT Manufacturing Engineering) to gather requirements and ensure validation readiness.
- Support audits and inspections by providing validation documentation and responses.
- Maintain validation lifecycle documentation including validation plans reports deviations and change controls.
- Track and manage validation deliverables and timelines for projects.
- Stay current with industry best practices and regulatory changes
Required Skills/Certifications:
- Bachelors degree in Life Sciences Engineering Computer Science or related field.
- Experience in validation (equipment process software or computer systems).
- Familiarity with regulatory guidelines (GxP 21 CFR Part 11 Annex 11 etc..
- Strong analytical documentation and problemsolving skills.
- Attention to detail and ability to manage multiple validation projects.
- Excellent communication and organizational skills
Preferred Skills/Certifications:
- Experience with computerized system validation (CSV).
- Knowledge of validation in regulated environments (e.g. pharmaceutical biotech medical devices).
- Proficiency in validation tools and documentation software.
- Relevant certifications (e.g. ISPE ASQ or CSV certifications).
Min Citizenship Status Required: US Citizen
Physical Requirements:No Physical requirement needed for this position.
Location: Remote US (EST)
Required Experience:
IC
Employment Type
Full Time
