Senior Computer Systems Validation Engineer
2 weeks ago
Location: Remote
Type: Contractual Engagement
Duration: Minimum of 1 year
Overview: We are in search of proactive and driven professionals who thrive in collaborative environments and are eager to be part of a company that prioritizes its culture and workforce as its core strengths. Join us as a Computer Systems Validation Specialist.
Together, we will tackle our clients' most pressing business challenges by leveraging our industry insights, operational knowledge, and consulting proficiency.
Key Responsibilities:
- Utilize your expertise in 21CFR Part 11 systems validation and regulatory adherence across various computerized systems within pharmaceutical and biotech manufacturing, as well as other GxP and GAMP regulated sectors.
- Act as a project leader and advisor, offering regulatory insights to ensure compliance with specified requirements.
- Foster valuable relationships to achieve exceptional project results while identifying innovative opportunities for process improvements.
- Disseminate best practices, industry insights, and personal expertise to educate clients in both formal and informal settings.
- Proven experience in developing validation documentation, including GxP Assessments, Validation Plans, Risk Assessments, Requirements/Design/Functional Specifications, IQ/OQ/PQ Protocols, Reports, Traceability Matrices, and Standard Operating Procedures.
- Familiarity with Trackwise Digital (cloud-based solution).
- Demonstrated ability to plan and schedule validation activities and lifecycle deliverables, test execution, and deviation management in accordance with computer software assurance (CSA) principles.
- Professional understanding of 21CFR Part 11 systems validation and regulatory compliance across various computerized systems in GxP and GAMP regulated environments.
- Strong background in GAMP and capability to implement and execute new GAMP protocols.
- Experience assessing Data Integrity impacts on validations, including Audit Trail Risk Assessment.
- Adaptability to manage the full validation lifecycle in both oversight and hands-on capacities, with a willingness to take on new roles as needed.
- Bachelor's degree or equivalent from an accredited institution.
IT Solutions LLC is committed to providing equal employment opportunities to all employees and applicants, prohibiting discrimination and harassment of any kind without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state, or local laws.
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