Validation Engineer
2 months ago
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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