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:
Minimum2+ 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: