Process Engineer

US-CA-Seal Beach
Job ID
2017-1018
Category
Process Science

Overview

Dendreon is looking for an experienced Process Engineer with a minimum of 3 years related experience in cGMP/FDA regulated industry. This person will provide technical support to the Manufacturing and Quality organizations, and partner closely with Technical Experts and Regulatory on introduction and integration of new products, processes and formulations.

 

In this role, you will use professional concepts, company policies and procedures to solve a variety of problems, work on problems of moderate and complex scope in which analysis of situation or data requires a review of identifiable factors, and exercise judgment within defined procedures and practices to determine appropriate action. This job performed in a lab, office, or utility (noisy) environment. This person needs to be able to work with minimal supervision.

 

May be required to work alternate shifts.

Responsibilities

  • Provides 24/7 support for both routine and complex deviations. 
  • Provide timely assessment regarding potential product impact as well as possible contributing root cause determination using a variety of tools including (but not limited to) review of primary data, technical reports, patient history, trending reports and regulatory information. 
  • Escalates issues to appropriate site and corporate functions as necessary.
  • Generates protocols and reports to support process improvement and process validation activities at the IMF.
  • Assists with technical transfer activities for processes being transferred to or from the IMF.
  • Interacts with site and corporate functions to assess the scientific, regulatory, and business impact of process improvement initiatives. 
  • May assist in the management and implementation of approved process improvement projects at the IMF and contract manufacturing facilities. 
  • May author, own, or assess change controls related to changes to processes at IMFs and contract manufacturing facilities.
  • Participates in regulatory inspections as needed.

Qualifications

  • Minimum of bachelor’s degree in a scientific discipline or equivalent.
  • Minimum of 3 year related experience in cGMP/FDA regulated industry.
  • Proficient in MS Office applications.
  • Ability to sit or stand for extended periods of time.
  • Intermittent walking to gain access to work areas.
  • Finger dexterity sufficient to use a computer and to complete paperwork activities.
  • Vision sufficient to use a computer, to read written materials and to complete paperwork activities.
  • Hearing sufficient to communicate with individuals by telephone and in person.
  • Ability to lift up to 25 pounds. Limited exposure to (2ºC - 8ºC); (-20ºC); (-75ºC); (-196ºC) areas.
  • Must have the ability to work around laboratories, manufacturing areas and equipment, and regularly lift 10 – 20 lbs and lift up to 50 lbs.
  • Ability to gown aseptically for work in Clean Room environments.
  • Must have the ability to work around laboratories, manufacturing areas and equipment with exposure to blood, blood products or OPIM (other potentially infectious materials) while donning required personal protective materials.
  • Strong communication (verbal and written) and organizational skills required.
  • Schedule flexibility.

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