CQV Engineer

CQV Engineer at Novozen Healthcare LLC CQV Engineer at Novozen Healthcare LLC in Ayer, Massachusetts Posted in about 20 hours ago.

Type:

full-time

Job Description:

Title:

CQV Engineer -

Downstream Biologics Validation Location:

Devens, MA Employment type : (W2/1099) Job Summary We are hiring CQV Engineers to support a fast-paced biologics expansion project within a large-scale cell culture manufacturing facility. This role is heavily focused on hands-on qualification execution for downstream process equipment in a GMP environment. The ideal candidate will have strong experience executing IQ/OQ activities, performing field walkdowns, supporting SIP/CIP activities, and working directly on the manufacturing floor with biologics process systems. Responsibilities Execute IQ/OQ protocols for downstream biologics manufacturing equipment Perform field verification and system walkdowns against P&IDs and installed equipment Support wet testing, functional testing, and flow path verification activities Assist with SIP/CIP execution, steam mapping, and temperature studies Coordinate with Manufacturing, Engineering, and QC teams during qualification activities Verify maintenance status, material certifications, and operational readiness Execute validation documentation within ValGenesis Support troubleshooting and real-time issue resolution during qualification activities Required Experience 4+ years of CQV/validation experience in biologics or pharmaceutical manufacturing Strong execution experience with downstream process equipment Hands-on experience with IQ/OQ activities in GMP facilities Experience with chromatography, filtration, buffer transfer systems, tank farms, or bioreactors Familiarity with SIP/CIP processes and steam-in-place activities Experience working within electronic validation systems such as ValGenesis Strong GDP documentation practices and ability to work within compressed project schedules Preferred Background Large-scale cell culture manufacturing experience Experience supporting startup, expansion, or retrofit projects Ability to work independently in a shift-based manufacturing environment

Note:

This is an execution-focused CQV role. All protocols are pre-approved and already available within the validation system. Candidates will primarily support on-floor qualification execution and documentation activities. Salary The hourly rate for this position is $55 - $65 per hour (depending on experience). Benefits This is a contract position and does not include employer-provided benefits. Equal Opportunity Employer We are an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status. Background Check Background checks may be conducted in accordance with applicable laws Work Authorization Applicants must be authorized to work in the United States