Offer summary

Qualifications:

Bachelor's degree in Life Sciences, Engineering, Computer Science, or related field., Experience in validation of equipment, processes, software, or computer systems., Familiarity with regulatory guidelines such as GxP and 21 CFR Part 11., Strong analytical, documentation, and problem-solving skills..

Key responsabilities:

Develop and execute validation protocols for equipment, systems, or processes.

Document validation activities in accordance with regulatory standards.

Collaborate with cross-functional teams to ensure validation readiness.

Track and manage validation deliverables and timelines for projects.

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 cross-functional 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:

Bachelor's 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 problem-solving 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 profile