Validation Engineer in Los Angeles, CA at Apex Life Sciences

Date Posted: 2/2/2018

Job Snapshot

Job Description


Apex Life Sciences is seeking an enthusiastic Validation Engineer to join a growing biotech company!

DUTIES AND RESPONSIBILITIES:

  • This position will mainly be focused on writing and executing equipment validations associated with the manufacture of IMedical Devices during the preparation and transfer of operations from one facility to another close to the original site.
  •  This move is scheduled to start in Q1 2018.The candidate will also work closely with cross functional teams (R&D, Manufacturing, Quality Control) to help prepare their equipment, materials and laboratories for the move.
  • The main function of this position is to support the physical move of the business, so it will require flexibility and motivation to help with “other duties as assigned”.
  • Position requires working knowledge and proven experience with Installation Qualification (IQ), Operational Qualification (OQ), performance qualification (PQ), cleaning validation in support of the processes and equipment validations. This will all be done under the guidance of the Manufacturing Sciences (Technical Operations & Engineering) Group.
  • Write new validation (IQ/OQ/PQ) protocols for existing equipment
  • Transfer existing validation (IQ/OQ/PQ) protocols to new standard templates
  • Execute IQ/OQ/PQ protocols
  • Write IQ/OQ/PQ reports
  • Write new EQ (Equipment Specification) documents for existing equipment
  • Update existing EQ documents, where needed
  • Work with Manufacturing Sciences team to help R&D, Operations, and Quality Control prepare equipment & materials prior to the move.
  • Willingness to be flexible and participate in other activities, as assigned, to help the business prepare for the move. This may include, but not limited to:
    • Taking inventory of materials at both original and destination locations
    • Updating non-validation type documents
    • Pack-up of materials, equipment at origin site
    • Set-up of materials, equipment at destination site
    • Organization/coordination of equipment movement
    • Coordination of pre-move equipment calibrations, crating
    • Pre-Move equipment qualifications
    • Assistance with cleaning validations
    • Other duties as assigned
  • Willingness to participate or lead PPI Business System Kaizen and 5S events
  • Preferred – Lean or Six Sigma exposure
  • Mindset for continuous improvement
  • Adhere to relevant Medical Device / pharmaceutical regulations and current interpretations affecting product, process, equipment, and cleaning validation.
  • This position requires a high level of organization
  • Promote a collaborative Team environment that fosters creativity, innovation and high performance.

 REQUIREMENTS:

  • Bachelor’s degree (or higher) required, with majors in Engineering or Natural/Life Sciences.
  • At least 3 years’ relevant experience in IVD/medical device arena required
  • Working knowledge & proven experience with equipment qualification (IQ/OQ/PQ), cleaning validation, and computer/automation systems.
  • Strong project management and organizational skills.
  • Excellent verbal and written communication skills.
  • Excellent use of Microsoft Office Suite.
  • Must work well with a cross functional team, and be ready to serve our internal “Customers” (Operations, Research, Quality Control departments) on a daily basis

If interested and qualified, please email your most updated resume to losangeles@apexlifesciences.com !

EEO Employer

Apex is an Equal Employment Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other characteristic protected by law. Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact our Employee Services Department at employeeservices@apexsystemsinc.com or 844-463-6178.

EEO Employer

Apex is an Equal Employment Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other characteristic protected by law. Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact our Employee Services Department at employeeservices@apexsystemsinc.com or 844-463-6178.