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:
· Manage the implementation, development and changes associate with process equipment Commissioning, Qualification and validation
· Communicate proactively with stakeholders to ensure on-time delivery of qualification tasks.
· Generate protocols and manage IOPQ qualification of equipment.
· Review and approve other technical documents, wherever applicable
· Support MES implementation process
· Manage deviations, support SOP generation.
· Provide input on project schedule
Qualifications:
· Bachelor of Science degree in Biological Sciences or Biomedical/Chemical Engineering.
· 3 to 8 years’ 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.
· Technical understanding of upstream and downstream unit operations
