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Process Validation Engineer (cGMP – BioPharma) JD816730

JD816730

DPS is seeking a knowledgeable Process Validation Engineer to work with a BioPharma client in the Boston, MA area. Preferred candidates should have experience working within aseptic and GMP environments.

Category:
Process Engineer
Location:
Massachusetts
Years of Experience Req.:
4+
Date Posted:
15/07/2019
Days Remaining:
26
Employment Type:
Full-time
Education Level Req.:
Bachelors

Process Validation Engineer (cGMP – BioPharma)          JD816730

Boston, MA area

 

DPS is seeking a knowledgeable Process Validation Engineer to work with a BioPharma client in the Boston, MA area.  Preferred candidates should have experience working within aseptic and GMP environments.

 

Responsibilities:

 

  • Must be able to be able to write and execute cleaning and process validation protocols.
  • Has a proven track-record of successfully executing process validation activities.
  • Summariz37511.0465881e and evaluate process and cleaning validation findings in a clear, orderly and succinct manner.
  • Performs process validation sampling according to current Standard Operating Procedures (SOPs).
  • Writes and executes process validation protocols, technical documents and final reports.
  • Prepares, reviews, and executes process validation protocols, reports, and other relevant documents as they pertain to specific validation requirements.
  • Works on complex problems where analysis of situations or data requires an in-depth evaluation of various factors.
  • Reviews and assesses process and cleaning changes and their impact to the validation status following appropriate change control procedures.
  • Ensures that procedures, work instructions, standards maintenance documents or master documents describe critical parameters or ranges determined in validation studies.
  • Maintains professional working relationship with co-workers and staff.

 

Qualifications & Experience:

  • Bachelor's degree in Engineering (Chemical or Mechanical) or related Scientific discipline.
  • 3+ years’ of process/cleaning validation experience.
  • Must be able to work independently with minimum direction and supervision.
  • Must have a strong background in Process/Cleaning Validation across the Biotech industry.
  • Must be able to work with multiple individuals as part of a cross-functional team.
  • Must have excellent communication skills.
  • Must be able to work in a dynamic and fast-paced environment.
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