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Validation Engineer

Job Attributes

Job Id:

15835

Job Category:

Clinical & Life Sciences

Job Location:

Gaithersburg, MD  20878

Security Clearance:

Not Defined

Business Unit:

Piper Companies

JOB DESCRIPTION

Process Validation Engineer

Piper Companies is seeking a Process Validation Engineer for the MS&T group of a local biopharmaceutical company. The Engineer will provide expert technical support to Commercial Operations, both Bulk Manufacturing and Fill/Finish. They will be specifically dedicated to supporting a critical process validation in a large cell culture manufacturing facility.

 

Responsibilities for the Process Validation Engineer:

  • Assembling and reviewing all information required for the PPQ report
  • Helping with the creation, authoring, and review/approval of the PPQ reports
  • Experimental support for deviations or manufacturing investigations
  • Process troubleshooting, Raw Material evaluation, Planning and execution of validation programs
  • Continuous process monitoring and improvement
  • Responsible for analyzing and drawing accurate conclusions and recommendations from the process and experimental data.

 

Qualification for the Process Validation Engineer:

  • Bachelor’s degree in a relevant technical discipline (Chemical Engineering or Life Sciences)
  • Minimum 2-5 years hands-on process validation experience 
  • Experience in the medical device and/or FDA regulated industry.
  • Knowledge of large scale biotechnology unit operations, principles of SIP and CIP, principles of biochemical engineering, and process data analysis.
  • Understanding of compliance and cGMP considerations.
  • Demonstrated commitment to continuous improvement – at the individual, department and organizational levels.
  • Knowledge and application of a disciplined project management process.

 

Compensation for the Process Validation Engineer:

Salary: $85,000 - $100,000

 

Full Benefits: Medical, Dental, Vision, Paid time off, and 401K

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New Search

Job Id:

15835

Job Category:

Clinical & Life Sciences

Job Location:

Gaithersburg, MD  20878

Security Clearance:

Not Defined

Business Unit:

Piper Companies