Senior Quality Validation Engineer
2 weeks ago
Azzur Group is a GxP compliance and consulting organization focused on providing quality-driven solutions that propel life science companies toward success. We are currently seeking a Senior Quality Validation Engineer who is passionate about ensuring the highest standards of quality in the pharmaceutical and biotechnology sectors. If you're a dedicated professional with a desire to engage, learn, and adapt within a dynamic healthcare landscape, you will fit right into our core values: Put Others First, Have the Courage to Take Action, Take Personal Responsibility, and Have Fun
Key Responsibilities:
- Review validation lifecycle documentation including but not limited to specification documentation (URS, FDS, CS), protocols, reports, executed validation packages, and trace matrices to meet industry standards.
- Represent the client's best interests and tactfully challenge the robustness of validation documentation.
- Collaborate with cross-functional teams to implement and maintain validation processes, ensuring alignment with quality assurance principles and best practices.
- Apply advanced statistical tools and methodologies to analyze validation data, ensuring informed decision-making related to quality outcomes.
- Provide subject matter expertise during regulatory audits and inspections, ensuring all validation records and documentation are compliant and readily available.
- Mentor and guide junior validation engineers, fostering a collaborative environment that encourages knowledge sharing and professional growth.
- Stay abreast of industry best practices, regulatory updates, and emerging trends in quality validation to continuously improve processes.
Requirements
Qualifications:
- Bachelor’s degree in Engineering, Life Sciences, or a related field; a Master's degree is a plus.
- 8+ years of experience in quality validation within the biotech or pharmaceutical industry.
- Proven experience in regulatory compliance and quality assurance practices, specifically in validation activities such as IQ, OQ, PQ, and process validation.
- Strong communication skills, both verbal and written, with the ability to effectively present validation data, findings, and recommendations to stakeholders.
- Experience with major equipment validation including tanks, filter presses, centrifuges, utilities, and facilities.
- Strong knowledge of regulatory guidelines (FDA, EMA, cGMP, ISO) and industry standards specific to validation.
- Excellent analytical and problem-solving skills, with a demonstrated ability to address complex challenges in validation processes.
- Proficient in statistical analysis software and tools to support validation activities.
Benefits
Azzur Group is an equal opportunity employer and promotes a diverse culture in our workplace. We believe that promoting diversity plays an important role in developing top-quality talent, fostering greater innovation and creativity, and enhancing our relationships with customers and the communities in which we operate. All qualified applicants will receive consideration for employment without regard to race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, age, marital status, pregnancy, genetic information, or other legally protected status.
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