Sr. Validation Engineer

Employer
Bachem
Location
Vista, CA, US
Posted
Nov 03, 2020
Ref
630296901
Hotbed
Biotech Beach
Required Education
Bachelors Degree
Position Type
Full time
Your Responsibilities

The Sr. Validation Engineer / Quality Engineering (QE) fulfills a critical role in GMP operations, supporting the qualification of equipment, facilities, utilities, and cleaning validation activities for API and PMO manufacturing. This position will work in close cooperation with Manufacturing, Engineering, and other functional areas to plan and perform validation activities under the Quality Engineering scope of work. This individual must monitor facility / utility validated systems, plan, write and execute validation/ qualification protocols, reports, and other technical documents, as well as conduct related investigations.

Your Tasks
  • Oversee or independently plan and execute qualification (DQ, IQ, OQ, PQ)/ validation activities under the Quality Engineering scope of work
  • Provide qualification / validation guidance and strategy during project planning and development phases
  • Support / review the change control process, performing risk assessments, and assessing the adequacy of validations requirements
  • Address deviations, and generate CAPAs, as required
  • Develop, plan and perform cold storage unit validation / temperature mapping using existing data loggers, including managing the calibration of the units
  • Review periodic utility system verifications / monitoring (purity test)
  • Review periodic cleanroom pressure differential monitoring
  • Conduct and document investigations related to validation activities
  • Develop and execute cleaning validation protocols and generate validation reports per established acceptance limits and criteria
  • Plan and perform required periodic re-validation / re-qualification activities
  • Perform QA review of equipment calibration documents
  • Draft SOPs and technical reports
  • Train operations staff on protocols, procedures and technical details related to systems, equipment and cleaning processes
  • Demonstrate commitment to the development, implementation and effectiveness of Quality Management System per ISO, FDA, and other regulatory agencies requirements.
  • Contribute to GMP systems improvements

Your Profile
  • Bachelor's Degree in science related field (engineering, chemistry, biology or equivalent)
  • Minimum of 5 years pharmaceutical validation experience, including experience in planning, writing and executing qualification protocols (IQ, OQ, PQ) and reports
  • Qualification experience in process equipment, including parts washers, sanitary vessels, lyophilizes, and chromatography systems
  • Experience with data logger equipment
  • Experience with validation / monitoring of clean pharmaceutical utility systems, including purified water and Nitrogen systems
  • Experience with cleanroom validation and HVAC systems
  • Experience with equipment calibration requirements
  • Experience in writing standard operating procedures (SOP) and technical reports
  • Strong knowledge of GMPs, FDA and EU guidance/ requirements related to validation
  • Excellent written and oral communication skills
  • Basic computer knowledge, including Microsoft Word, Excel, PowerPoint and Visio
  • Ability to effectively organize, multitask, and work in a fast-paced, deadline driven work environment
  • Ability to communicate in a proactive and solution-focused manner, including keeping management aware of potential issues
  • Detail oriented with the ability to troubleshoot and resolve problems
  • Ability to work independently and manage one's time
  • Communicate effectively and ability to function well in a team environment

Coach and mentor validation personnel as well as oversee the activities of contractors / vendors (as

necessary)



Preferred:
  • Master's degree in science related field (engineering, chemistry, biology or equivalent)
  • Experience with Cleaning Validation
  • Experience with Lean Six Sigma methods: Root cause analysis, failure mode analysis and analyzing / organizing complex technical problems.



We Offer

You will be part of a motivated team overseeing the entire development cycle of respective APIs. If you are

looking for a new challenge and want to join a motivated team in an internationally renowned company, you should seize this opportunity

Nearest Major Market: San Diego