Demo

Process Engineer

Brightpath Associates LLC
Boca Raton, FL Full Time
POSTED ON 1/23/2025
AVAILABLE BEFORE 2/20/2025

Job Description

The Process Engineer I will provide process development and Transfer support for IgG Immunotherapy Production. Provide updates to Process Development (PD) Management team on a regular basis to ensure compliance issues are being met. Responsible for maintaining compliance in PD laboratory and executing process development/evaluation studies as well as process validations using a scale down model.


Responsibilities:

  • Provide support for technical issues related to the manufacturing process and product quality.
  • Develop new processes as required for production of plasma derived therapies.
  • Be familiar with regulatory guidelines to process development/validation as well as implementing manufacturing process changes.
  • Optimize and maintain compliance in PD laboratory by ensuring all equipment calibration/IQ/OQ/PM status are current.
  • Participate in designing and planning scientific experiments to achieve corporate goals for existing projects.
  • Review and/or approve cGMP documentation generated by other PD group members as necessary.
  • Lead execution of process development/evaluation studies as well as process validations using a qualified scale down model.
  • Act as a liaison between PD and Manufacturing for supporting deviations and investigations as well as when transferring new and/or optimized processes.
  • Maintain and review process development Batch Records for scale down process models.
  • Perform other activities as assigned by the PD Managers.


Education Requirements:

  • Bachelor’s degree in Science or Engineering

Experience Requirements:

  • At least three (3) years of experience in a cGMP, Pharmaceutical/Biological manufacturing environment, familiarity with many aspects of process development is expected.
  • Knowledge of FDA cGMP requirements is an essential pre-requisite for this position.

If your compensation planning software is too rigid to deploy winning incentive strategies, it’s time to find an adaptable solution. Compensation Planning
Enhance your organization's compensation strategy with salary data sets that HR and team managers can use to pay your staff right. Surveys & Data Sets

What is the career path for a Process Engineer?

Sign up to receive alerts about other jobs on the Process Engineer career path by checking the boxes next to the positions that interest you.
Income Estimation: 
$86,732 - $101,718
Income Estimation: 
$106,100 - $124,886
Income Estimation: 
$86,732 - $101,718
Income Estimation: 
$106,100 - $124,886
Income Estimation: 
$106,100 - $124,886
Income Estimation: 
$130,074 - $155,489
Income Estimation: 
$51,081 - $58,472
Income Estimation: 
$58,474 - $66,880
Income Estimation: 
$74,901 - $86,706
Income Estimation: 
$86,732 - $101,718
View Core, Job Family, and Industry Job Skills and Competency Data for more than 15,000 Job Titles Skills Library

Job openings at Brightpath Associates LLC

Brightpath Associates LLC
Hired Organization Address Midland, TX Full Time
Job Description General Requirements: Excellent verbal, written, and interpersonal communication skills required, with t...
Brightpath Associates LLC
Hired Organization Address Lovington, NM Full Time
Position Summary As the Manager of Engineering, you'll be a key figure in managing both the immediate and long-term perf...
Brightpath Associates LLC
Hired Organization Address Tilton, NH Full Time
Job Title : CNC Machinist B - 2nd Shift Job Location: Tilton, NH Job Type: ​Full Time Shift: 2nd Shift - 3:15PM to 11:45...
Brightpath Associates LLC
Hired Organization Address Annapolis, MD Full Time
We are seeking qualified applicants for the position of Software Engineerfor Defense programs. The Software Engineer wil...

Not the job you're looking for? Here are some other Process Engineer jobs in the Boca Raton, FL area that may be a better fit.

Process Engineer

Rise Technical, Clewiston, FL

Process Engineer II, Process Development

ADMA BIOMANUFACTURING LLC, Boca Raton, FL

AI Assistant is available now!

Feel free to start your new journey!