Validation Engineer – Cleaning Validation
| Company | Serán BioScience |
|---|---|
| Location | Bend, OR, USA |
| Salary | $Not Provided – $Not Provided |
| Type | Full-Time |
| Degrees | Bachelor’s |
| Experience Level | Mid Level |
Requirements
- Knowledge of FDA cGMP guidelines and regulations acquired through education, experience, and training; additional knowledge of global regulatory requirements highly desirable (E.g., MHRA / EMEA)
- Understanding of the Compliance and Technical requirements on the application of various scientific concepts used for developing different dosage forms of pharmaceutical products (primarily oral solid dose)
- Familiarity with water systems, CIP, Part Washers, and OSD process equipment
- Hands on experience with execution of cleaning verification studies and sampling methods (swab, rinse, visual, etc.)
- Proven experience with cleaning validation, protocol development, execution, troubleshooting, and summary reports
- Effective written, oral, and interpersonal communication skills
- Communicates effectively and maintains productive relationships with coworkers, clients, and other contacts outside the Company
- Accepts feedback from a variety of sources and constructively manages conflict
- Strong time-management skills and the ability to organize and coordinate multiple projects at once
- Proficiency in enterprise systems, Microsoft Office, and other office productivity tools, with aptitude to learn new software and systems
- Bachelor’s degree in engineering or related technical field
- A minimum of 3 years of experience with pharmaceutical manufacturing, engineering, validation, or other relevant experience in cGMP environment
Responsibilities
- Evolve and manage cleaning verification / validation program for clinical supply manufacturing facility
- Leads and supports projects for new product introduction, tech transfer, product / process optimization in a clinical manufacturing facility for oral solid dose products
- Authors and executes commissioning, qualification, and validation protocols and reports
- Defines and coordinates execution of cleaning development studies for manufacturing equipment
- Facilitates and drafts risk assessments with interdisciplinary teams related to equipment design, operation, and cleaning processes
- Leads continuous improvement initiatives related to manual and automated cleaning processes
- Defines and tracks metrics to assess cleaning program effectiveness and efficiency
- Leads and supports investigations related to process equipment operations and cleaning processes
- Supports capital projects and implementation of new technologies
- Responsibilities may increase in scope to align with company initiatives
- Performs other related duties as assigned
Preferred Qualifications
- Additional knowledge of global regulatory requirements highly desirable (E.g., MHRA / EMEA)