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 & Responsibilities:
- Conduct toxicology and equipment data collection
- Manage equipment Hold Time Studies
- Oversee CIP, SIP, Autoclave and various equipment PQ
- Perform assessment for E&L and Cleaning Confirmation
- Experienced in Worst Case Soil studies and Cleaning Validation
- Assess all major deviations for impact product quality
- Validation Protocol development
- Take ownership of subsequent CAPA
- Effectively work with other departments and interface with customers
Qualifications:
- Bachelor of Science degree in Biological Sciences or Biomedical/Chemical Engineering
- Experience in biotech industry in process development and process scale up / manufacturing
- Experience with large-scale manufacturing support, current Good Manufacturing Practices, US / EU regulations
