Validation Engineer
2 weeks ago
No Deviation is a provider of patient-centric solutions for the pharmaceutical industry, and we are currently seeking individuals who are passionate about joining our team. Our areas of expertise include engineering consultancy, Commissioning Qualification Validation (CQV), as well as Quality, Compliance, and Regulatory services.
We strongly uphold our core values of Empathy, Integrity, and Transparency, and we strive to create a collaborative, innovative, and inclusive work environment that fosters personal growth and development.
By joining our team, you will have the opportunity to make a meaningful impact in the pharmaceutical industry while advancing your career.
**Scope and Responsibilities**:
Execute and close out validation activities, including equipment and utilities qualification, facility qualification (in line with EU Annex 1), and controlled temperature chamber qualification with temperature mapping.
Develop or support the creation of validation documentation, such as Risk Assessments, plans, protocols, and reports.
- and risk-based approach to validation activities.
Analyze, interpret, and summarize data from executed validation studies.
Investigate or support investigations of deviations or non-conformities identified during validation activities.
Work effectively with stakeholders, including cross-functional teams, clients, and corporate functions, to ensure seamless project delivery.
Ensure safety, quality, and timely delivery of validation projects.
Adhere to validation lifecycle approaches (e.g., URS, FAT/SAT, commissioning, IO/PQ protocols) and international regulatory requirements.
**Qualifications**:
Bachelor’s degree in a science or engineering discipline.
Minimum of 2 years of experience in pharmaceutical CQV.
Strong understanding of validation lifecycle processes and regulatory guidelines.
Familiarity with industry best practices for equipment and utilities qualification.
Fluent in written and spoken English.
Adaptable to a fast-paced, dynamic work environment.
A quick learner with a proactive "Can-do" attitude.
Exceptional time management skills with strong attention to detail.
Proficiency in presentation and facilitation is an advantage.
**EA License No**: 19C9587
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