Validation Engineer

Serán BioScience is seeking a Validation Engineer of various experience levels to support the cleaning verification and validation program for clinical phase testing of novel pharmaceutical drug products. The Validation Engineer will be responsible for developing and executing commissioning and qualification protocols for equipment and systems and performing validation studies for process, cleaning, computerized systems, and critical utilities needed to support clinical and commercial distribution of non-sterile Oral Solid Dosage pharmaceutical products. Initial focus will be to evolve and manage a cleaning verification and validation program for clinical drug product production.

Duties And 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
  
  
  

Required Skills And Abilities

• 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
  
  
  

Education And Experience

• 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
  
  
  

Physical Requirements

• Prolonged periods of sitting at a desk and working on a computer
• Prolonged periods of sitting or standing in a manufacturing environment
• Must be able to lift fifteen pounds at times
• Adheres to consistent and predictable in-person attendance
  
  
  

Visit https://www.seranbio.com/careers to learn more about company culture and the community of Bend, Oregon.

Applicants must be authorized to work for an employer in the U.S. We are unable to sponsor or take over sponsorship of an employment Visa at this time.

Benefits Summary:

Serán employees accrue over four weeks of paid time off annually. Employer contributions to a retirement account begin after 90 days and do not require an employee match or vesting period. Various health plans allow employees to find the best coverage for their individual or family needs with minimal employee contributions. Serán covers each employee with basic life and long-term disability, giving access to increase or add coverage. An Employee Assistance Program provides support for all things related to our employees’ wellbeing, along with access to pet insurance.

The Corporate Headquarters of Serán BioScience are located at 63047 Layton Ave, Bend, OR 97701