Engineer in Thousand Oaks, CA at APEX Systems

Date Posted: 1/4/2020

Job Snapshot

Job Description

Job #:  1036502


Apex Systems is currently looking for an Engineer for one of our Bio-Tech companies located in Thousand Oaks, CA
If you find yourself to be a good fit for this role please send your resume directly to tlingram@apexsystems.com.
  • The Engineer will work under the team: Mechanical Engineering Methods.
  • They will be responsible for engineering activities required for the development, qualification, validation, and transfer of Physical GMP Test Methods for combination products, devices, primary containers, and secondary packaging components.
  • The Engineer will have the ability to work on projects that may involve changes or new product, processes, tooling, or equipment introduction to improve quality, reliability and reduce cost.
  • Phases of projects include: developing combination product test methods, providing key expert support for qualification, validation, transfer, and life cycle support of methods for manufacturing, new product introduction, training, and production support.
  • Responsibilities may include the following:

    • • Develop, qualify, and validate GMP physical test methods for vials, prefilled syringes, and injection devices.

    • • Provide support of senior staff for investigations as well as new process development required to improve manufacturing operations.

    • • Coordinate test method development and delivery with selected contractors and vendors.

    • • Ensure that qualification parameters are met for product requirements.

    • • Generate procedures necessary to support department and new process equipment.

    • • Maintains integrated timelines capturing appropriate cross functional details and deliverables which are aligned with the functional and project goals

    • • Participate in and assume responsibilities of team functions as assigned - i.e. subject matter experts for test equipment

    • • Generate/author and own the Test Method documents: Procedures, engineering drawings, specifications, protocols, reports, etc.

    • • Gather test method requirements that result in equipment that operates safely and considers ergonomic factors in the design

    • • Perform other duties as required by the Group Manager

    • • Comply with the requirements, responsibilities, and authority as required

    • • Communicate and collaborate internally to ensure alignment, commitment to project objectives and timelines as well as to ensure effective execution of projects

    • • Network with manufacturing, quality and regulatory organizations both internal and external to Amgen

    • • Excellent verbal and written communication skills are utilized to communicate project status and risks associated with integrated timelines to leadership

 
 
 
 
 
 
 
 
EEO Employer
Apex Systems is an equal opportunity employer. We do not discriminate or allow discrimination on the basis of race, color, religion, creed, sex (including pregnancy, childbirth, breastfeeding, or related medical conditions), age, sexual orientation, gender identity, national origin, ancestry, citizenship, genetic information, registered domestic partner status, marital status, disability, status as a crime victim, protected veteran status, political affiliation, union membership, 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 844-463-6178.