Search Jobs | Dice.com

2 results (0 new)

Group by company

CQV Engineer

Katalyst Healthcares and Lifesciences

San Francisco, California • Today

Full-time

CQV Engineer

Katalyst Healthcares and Lifesciences

Remote or New Jersey • Today

Full-time

Job Details

Skills

Design Review
URS
RTM
IQ
OQ
PQ
Automated Testing
Management
Process Engineering
GxP
Capital Expenditures
GMP
Manufacturing
Documentation

Summary

Job Description:
We are looking for CQV Engineers / System Owners to take ownership of specific process and utility systems within either the Bulk (Drug Substance) or Fill Finish (Drug Product) areas on a large-scale greenfield.
This role focuses on system ownership across the full CQV lifecycle, from design review through to qualification and handover, ensuring all systems are delivered in line with GMP and project standards.

Responsibilities:

ct as System Owner for assigned equipment within Bulk or Fill Finish areas.
Participate in design reviews and ensure alignment with URS and GMP requirements.
Lead and/or support development of GxP documentation (URS, SRA, DQ, RTM, protocols).
Support commissioning and qualification activities (FAT, SAT, IQ/OQ/PQ where applicable).
Manage and track system deliverables in line with project schedule.
Coordinate with CQV, Engineering, Automation, QA, and Construction teams.
Identify and manage risks, issues, and dependencies related to assigned systems.
Support verification planning aligned to ASTM E2500 methodology.
Ensure systems are ready for handover to validation/operations.

Requirements:

4-7 years' experience within CQV / Process Engineering in GMP environments.
Hands-on experience with system ownership and equipment qualification.
Strong understanding of CQV lifecycle and GxP documentation.
Experience working on large CAPEX or GMP manufacturing projects.
Familiarity with ASTM E2500 / risk-based qualification approaches (preferred).
bility to work in a cross-functional, fast-paced project environment.
Familiarity with KneTelecommunicationrade; (electronic CQV documentation platform) is a nice to have.

Employers have access to artificial intelligence language tools (“AI”) that help generate and enhance job descriptions and AI may have been used to create this description. The position description has been reviewed for accuracy and Dice believes it to correctly reflect the job opportunity.

Dice Id: 91116760
Position Id: a4609f943bb8f31d4ed656312dc25fd6
Posted 30+ days ago

Fitment

Dice Job Match Score™

📋 Comparing job requirements...

Create job alert

Never miss an opportunity! Create an alert based on the job you applied for.

Alameda, California

•

Today

About Us We are Sila, a next-generation battery materials company. Our mission is to power the world's transition to clean energy. To create this future, our team is building a better lithium-ion battery from the inside out today. We engineer and manufacture ground-breaking battery materials that significantly increase the energy density of batteries, while reducing their size and weight. The result? Smaller more powerful batteries that can unlock innovation in consumer devices and accelerate t

Full-time

USD 151,000.00 - 191,000.00 per year

Senior CQV Engineer/Validation Engineer

No location provided

•

Today

Direct hire /Full time On-site Boulder, CO Salary expectation: You povide Summary We are seeking a highly motivated Senior CQV Engineer to support commissioning, qualification, and validation activities for pharmaceutical and biotechnology manufacturing facilities. The successful candidate will lead and execute CQV deliverables associated with GMP-regulated process equipment, utilities, automation systems, cleanrooms, and manufacturing operations. This role requires hands-on technical expertis

Easy Apply

Full-time

$DOE

Lead Validation Engineer

New Jersey

•

Today

Job Description: The Lead Validation Engineer leads GMP equipment installation, commissioning, and qualification projects supporting large-molecule biologics manufacturing. This role supports upstream and downstream processes and ensures projects are executed safely, on schedule, and in compliance with regulatory and quality requirements. Responsibilities: Lead end-to-end CQV execution for GMP equipment projects, managing activities from installation through IQ, OQ, and PQ for biologics manufact

Full-time

CQV Engineer

Remote or New Jersey

•

Today

Summary : This position will be responsible for providing Commissioning, Qualification and Validation support to the cGMP Clinical and Commercial Cell Therapy Manufacturing plant. This individual will be responsible in handling day-to-day activities inclusive of execution, protocol management, vendor management, issues, deviations, corrections and remediation efforts for facility, equipment, systems and processes in support of personalized cell therapy production through safe and compliant manuf

Full-time