Validation Engineer

1 week ago

framingham, United States LS Solutions Full time

Job Title: Validation Engineer, Temperature Control Mapping

Location: Framingham, MA

Duration: 6 + months contract


JOB DESCRIPTION

Our client is a small biotechnology company based in Framingham, MA that provides development, manufacturing and services. Primarily focusing on upstream manufacturing of the recombinant proteins.


Responsibilities:

  • Execute TCU Mapping Protocols: Perform and document temperature mapping activities to ensure TCUs meet regulatory and operational standards.
  • Protocol Support: Assist with validation protocols, ensuring adherence to internal and regulatory requirements.
  • Data Collection & Analysis: Support data collection and preliminary analysis of TCU mapping results to inform validation reporting and quality control.
  • Collaborate and Learn: Work under the mentorship of a senior engineer and receive guidance from an experienced leader preparing for a supervisory role.
  • Ensure Compliance: Help maintain compliance with GMP, safety, and internal quality standards in all mapping activities.

Required Skillset

Qualifications:

  • Minimum 2+ years in engineering or validation roles, ideally within regulated industries such as life sciences or pharmaceuticals.
  • Experience with equipment such as TCUs and temperature mapping
  • Experience in QC analytical methods.
  • Bachelor’s degree in engineering, Chemistry, or a related technical field
  • Basic understanding of temperature mapping, calibration, and relevant validation protocols.
  • Strong attention to detail and analytical skills for data review and protocol adherence.
  • Eager to learn and work under mentorship within a team environment, with strong communication and collaboration skills.

Experience with any of the following instrumentation or software is highly desired:

  • SD Tanks
  • TruScan ALZ
  • TruScan EQP
  • Biomek i5
  • TCU Framingham
  • Agilent GC 7890
  • Validation Program Overhaul
  • Coswin
  • Slingshot - Server
  • Commissioning - Glasswasher and Dryer
  • QC Micro autoclave
  • Genesys Spectrophotometer current
  • Cleaning Requalification
  • Small Parts / (4) UF DF
  • Temp Mapping
  • TCU
  • Endoscan
  • ENNOV
  • Smoke Study MFG
  • Genesys Spectrophotometer new printer
  • Commissioning – Verification
  • TrackWise
  • Endoscan
  • TruScan ALZ
  • TruScan EQP
  • Biomek i5
  • Agilent GC 7890
  • Commissioning - Glasswasher and Dryer
  • QC Micro autoclave
  • TCU Framingham Refrigerator
  • LIMS
  • Genesys Spectrophotometer
  • ENNOV

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