CQV Validation Engineer (GMP / Kaye Systems) - Cell & Gene Therapy

CQV Validation Engineer (GMP / Kaye Systems) - Cell & Gene Therapy at JMD Technologies Inc. CQV Validation Engineer (GMP / Kaye Systems) - Cell & Gene Therapy at JMD Technologies Inc. in Somerville, Massachusetts Posted in about 22 hours ago.

Type:

full-time

Job Description:

Title:

CQV Validation Engineer ( GMP / Kaye Systems )

Location:

Greater Boston Area, MA (Hybrid 2-3 days onsite)

Employment Type:

Contract Status:

Accepting Candidates About the role Join a high-impact engineering team supporting commissioning, qualification, and validation activities within a regulated biotech environment. This role focuses on ensuring systems and equipment meet cGMP and quality standards across the project lifecycle. Key Responsibilities Execute CQV (Commissioning, Qualification, Validation) activities for equipment and systems Develop and execute

IQ/OQ/PQ

protocols in a GMP environment Utilize Kaye Validator and data loggers for thermal validation activities Collaborate with cross-functional teams including Engineering, QA, and Operations Ensure compliance with

GMP, GAMP, ISO, ANSI

standards and internal SOPs Support validation lifecycle including documentation, deviations, and change controls Qualifications Bachelor's degree in Engineering (Chemical, Biomedical, Industrial, Biotechnology) or related field 8+ years of experience in CQV validation within GMP regulated industries Hands-on experience with Kaye Validator / data loggers Strong knowledge of

GMP, GAMP, ISO

standards and validation principles Proven experience executing validation protocols and troubleshooting technical issues Ability to work independently and adapt in a dynamic project environment Compensation (MA Pay Transparency): Estimated hourly range: $70-$75/hr (W-2). Final rate within this range will be based on skills, experience, and interview results.