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Engineer - AFP

Apex Systems Thousand Oaks Contractor
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Description:

The Engineer will serve as a technical lead for the Biotechnology Manufacturing facility for the facilities and engineering team.

  • Provide technical support to complex engineering equipment and processes.
  • Entry level experience in design, qualification, operation, maintenance and improvement of biopharmaceutical equipment will be required to support day to day manufacturing activities as well as to participate in improvement projects.
  • Applies diverse engineering principles to the design and implementation of major system modifications, process and/or capital projects.
  • Organizes, analyses and presents interpretation of results for operational issues or engineering projects of significant scope and complexity. General equipment knowledge to perform basic troubleshooting of equipment failures or malfunctions and/or the development of technical assessments.

Responsibilities

  • Assist in the identification of critical quality parameters and process attributes for new equipment or facility modifications.
  • Assist in development and review of User Requirements Specifications (URS).
  • Suggest design modifications to address risks and design in quality and safety.
  • Organizes, analyses and presents interpretation of results for operational issues or engineering projects of significant scope and complexity.
  • Perform basic troubleshooting of equipment failures or malfunctions and/or the development of technical assessments.
  • Recommend, evaluate, and manage performance of contract resources
  • Provide oversight for verification deliverables developed by outsourced/contract verification staff.
  • Act as a liaison between Engineering and Quality Assurance during project planning, execution, and closeout
  • Ensure that validation protocols are executed and documented in accordance with cGMP good documentation and safety compliant practices.
  • Ensure safety during commissioning, validation, maintenance and manufacturing activities
  • Support Manufacturing and QA with Performance Qualification (PQ) activities.

Qualifications

  • General knowledge on Biopharmaceutical equipment operations and processes such as single use technologies, Media / Buffer Prep solutions, Inoculation, Bioreactors, Harvest, Chromatography and Tangential Flow Filtration as well as Clean Utilities.
  • Knowledge in Automation systems and processes such as RD’s, Delta-V and PLC. Basic knowledge in the design of maintenance and reliability activities such as job plan, data sheets and equipment reliability technology.
  • Experience in validation processes such as execution of Installation / Operation / Performance qualification documentation.
  • Experience in cleaning validation execution and documentation.
  • Knowledge of Operational Excellence practices such as lean manufacturing and lean maintenance. Employ basic engineering techniques and/or modifications within area of engineering expertise.
  • Serves as a peer-recognized engineering technology specialist with overall responsibility for determining methodologies in that area.
  • Application of engineering knowledge in planning and conducting low complex projects. Demonstrate project management skills and application of concepts.
  • Experience in investigation of deviations, development of corrective and preventive actions and generation and implementation of change controls.

Education Requirement

  • Bachelors with degree in engineering, chemical engineering preferred

Top 3 Must Have Skill Sets:         

  1. General knowledge on Biopharmaceutical equipment operations and processes such as single use technologies, Media / Buffer Prep solutions, Inoculation, Bioreactors, Harvest, Chromatography and Tangential Flow Filtration as well as Clean Utilities.
  2. General equipment knowledge to perform basic troubleshooting of equipment failures or malfunctions and/or the development of technical assessments.
  3. Experience in processes and cleaning validation such as execution of Installation / Operation / Performance qualification documentation.

For consideration please email most up-to-date resume with contact information to Brittany Waldron @ Email blocked - click to apply 
#LI-BW4
 

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

 

Skills required

Testing
Maintenance
Troubleshooting (Problem Solving)
Safety Assurance
Commissioning
Control Systems
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WHAT WE DO:

Apex Systems is a division of the 2nd largest IT staffing and services firm in North America. From consulting to staff augmentation, we connect top tech talent with great companies in all industries.

OUR CREDENTIALS: 

Apex earned Inavero’s Best of Staffing™ Client Diamond and Talent Awards for providing superior service to clients and job seekers, putting the company in the top 2 percent of all U.S. staffing agencies.

SUPPORTING OUR CONTRACT EMPLOYEES:

We take the time to understand a candidate’s talents and needs to ensure a good match with companies for contract, contract-to-hire, and direct hire positions. Each recruiter within Apex is focused on a specific skill area within infrastructure, applications, and project management. This focused discipline enables our local recruiters to work directly with our candidate’s and focus their talent on the right position at the right time.

WHO OUR CUSTOMERS ARE: 

We serve Fortune 500, mid-market, and emerging companies from a wide variety of industries, including communications, energy, financial services, government services, healthcare, technology, and utilities. 

WHERE WE ARE: 

Apex has branches in over 70 locations across the U.S. and Canada and more than 1,000 employees dedicated to supporting the needs of our clients and contract team members. Visit www.apexsystems.com to find a local branch or connect with an Account Manager or Recruiter.

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