Category: Life Science

Employment Type: Direct Hire

Reference: BH-372821

Our client, a global bio-pharmaceutical company, that specializes in core therapeutic and business areas, including gastrointestinal and inflammation, rare diseases, plasma-derived therapies, oncology, neuroscience and vaccines, is actively looking to add a Sr. Validation Engineer to their team. This position will be on-site in Los Angeles.



Salary: $85,000-$130,000

Location: Los Angeles, CA

Type: Direct Hire

Shift: Monday-Friday: 8:00am-5:00pm



KEY JOB RESPONSIBILITIES:

• Apply thoughtful understanding of cGXPs, GAMP5 and 21CFR Part 11 (as applicable), relevant SOP curriculum, routine project procedures, project management, and other training.
  
  
• Perform a variety of projects in several areas at the same time to support manufacturing and engineering.
  
  
• Responsible for planning, scheduling, and leading validation assignments. Must demonstrate planning and coordination.
  
  
• Review and change control requests with potential impact to validated state of validation elements, as applicable.
  
  
• Lead and interface with team members (Engineering, Manufacturing, Regulatory Affairs, Quality Operations, Quality Validation, Supply Chain, and other technical disciplines)
  
  
• Write protocols and reports, execute validation documents regarding acceptability to industry standards (GMPs, FDA Guidelines).
  
  
• Guide peers in Validation and Engineering Departments to use sound, statistically based Quality Engineering approaches in project, test plans and in analyses of test results.
  
  
• Utilize Quality-Engineering tools to problem solve/troubleshoot and assist in risk analysis.
  
  
• Use validation test equipment, such as, Kaye Validator and Ellabs loggers to support validation activities.
  
  

• Bachelor's degree in engineering discipline required. Chemical, Mechanical, Electrical Engineering Degree. 3+ years of related experience.
• Experience in manufacturing processes and control systems, cleaning processes, process equipment, facilities and critical support systems.
• Prior experience interacting with the FDA and other regulatory agencies.
• Must have experience, proficiency, and leadership in pharmaceutical/biotech validation elements, including the writing and implementing of protocols and standard operating procedures.
• Must be proficient in more than one validation element.
• Must have a comprehension of the operating principles in a cGMP regulated environment. Hands-on Manufacturing, Engineering and Technical Service experience.
• Must display a solid technical understanding of the validation element principles and scheduling a series of project technical and project management overviews.
• Must be able to lift, push, pull and carry up to 25 lbs.
• In general, you will have a combination of sedentary work and walking around observing conditions in the facility.
• May work in construction or demolition areas