Validation Engineer - Permanent - Bonita Springs, FL
Engineer validation that keeps pharma equipment-and compliance-running flawlessly.
探花合集 is seeking a Validation Engineer to join a dynamic team in Bonita Springs, FL. This position requires a detail-oriented professional who can develop and execute validation strategies while ensuring adherence to industry standards and regulatory requirements.
Primary Responsibilities:
The successful candidate will focus on equipment qualification, computerized systems validation, and compliance assurance within the pharmaceutical industry.
Skills & Requirements:
- Strong understanding of validation principles, including equipment qualification and computerized systems validation.
- Familiarity with industry standards such as ISPE Baseline Guide CQ, GAMP5, and 21 CFR Part 11.
- Proficiency in developing validation documentation and managing deviations.
- Experience with risk-based approaches to qualification activities.
- Knowledge of GxP requirements and data integrity principles (ALCOA).
- Ability to manage change control processes and ensure compliance with regulatory guidelines.
- Excellent organizational and communication skills.
The Validation Engineer's responsibilities will be:
- Develop and implement validation strategies aligned with ISPE Baseline Guide CQ 2nd Edition, FDA expectations, and internal policies.
- Conduct system impact assessments and equipment classification.
- Contribute to the creation of Validation Master Plans and project validation plans using a risk-based approach.
- Develop, review, and execute validation documentation, including system requirement specifications, design reviews, installation qualifications, operational qualifications, and performance qualifications.
- Ensure qualification documentation is accurate, complete, and compliant with GxP requirements.
- Manage deviations during qualification activities and support change control assessments.
- Participate in computerized system validation (CSV) activities for embedded software and standalone systems.
- Develop and execute validation plans for software systems, including risk assessments and test scripts.
- Ensure software systems comply with industry regulations such as GAMP5 and 21 CFR Part 11.
- Design and perform validation tests, including IQ, OQ, and PQ.
- Create and maintain validation documentation, including reports, traceability matrices, and protocols.
- Manage software change control processes and assess impacts on validated systems.
- Conduct risk assessments to identify and mitigate potential validation issues.
If you are having difficulty in applying or if you have any questions, please contact Anderson Maldonado at a.maldonadoproclinical.com
If you are interested in applying to this exciting opportunity, then please click 'Apply' or to speak to one of our specialists please request a call back at the top of this page.
探花合集 is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. 探花合集 is acting as an Employment Agency in relation to this vacancy.
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