Katalyst

Katalyst

105 jobs near Raleigh, NC

Summary: The CQV Engineer will be responsible for executing commissioning, qualification, and validation testing activities in a GMP pharmaceutical manufacturing environment. This role is strictly ...

Responsibilities: The Associate Inventory Analyst will support our continuous improvement and operational excellence goals by performing regular inventory counts and system analysis to identify ...

Summary: The Lead Validation Engineer will oversee and drive commissioning and qualification (C&Q) activities for automation and process systems at a regulated manufacturing site. This leadership ...

Summary: * The Lead Validation Engineer will oversee and drive commissioning and qualification (C&Q) activities for automation and process systems at a regulated manufacturing site. * This leadership ...

Engineering Intern

Chapel Hill, NC

$14 - $18/hr

* The Operational Excellence Engineer Intern will provide support to the OpEx Engineering team to help drive the Lean transformation and quality improvement initiatives in manufacturing by ensuring ...

Summary : Top 3 must have's: Life science Domain, Validation Skills, Delta V & MES Validation Roles & Responsibilities: • Lead and manage C&Q lifecycle activities including URS, DQ, IQ, OQ, and PQ ...

Assembler 1, General

Durham, NC

$14 - $16.25/hr

Responsibilities * Perform a wide range of production processes including but not limited to wiring, component, installation, cable assembly, and the assembly of complete units. * Assembles ...

This position is responsible for the successful implementation and coordination of equipment and facilities validation programs in compliance to cGMPs, FDA requirements and company policy.

Senior Process Engineer

Apex, NC

$100.30K - $129.70K/yr

Summary: * Senior Process Engineer to support process and utility systems within a regulated biopharmaceutical manufacturing environment at our Holly Springs site. This role is fully onsite and ...

This position is responsible for the successful implementation and coordination of equipment and facilities validation programs in compliance to cGMPs, FDA requirements and company policy.

Responsibilities: * Review protocols for CDISC conformance. * Review Case Report Forms and eCRFs with CDISC CDASH and SDTM conformant elements. * Write and manage SAS code for mapping clinical data ...

Summary : We're looking for dedicated, innovative and driven talent to join our expanding team as we are currently looking to hire an CSV Engineer to join our projects team in Wilson, NC supporting ...

Responsibilities: * Develop and execute IT validation activities and documentation, including protocols, test plans, and change controls. * Author validation plans, verification reports, and ...

Summary: The Senior Validation Engineer will lead and execute commissioning and qualification (C&Q) activities for automation systems at the. This role ensures compliance with GMP regulations and ...

Responsibilities: * Lead and manage clinical data management activities for oncology clinical trials, ensuring adherence to project timelines, budgets, and quality standards. * Provide strategic ...

Support 1, Operations Intern

Durham, NC

$13.75 - $18/hr

The Operational Excellence Engineer Intern will provide support to the OpEx Engineering team to help drive the Lean transformation and quality improvement initiatives in manufacturing by ensuring ...

This position is responsible for the successful implementation and coordination of equipment and facilities validation programs in compliance to cGMPs, FDA requirements and company policy.

Responsibilities: * Team provides customized real-world data and real-world evidence solutions to address the most important research questions across clinical development, market access, and ...

* We are seeking two experienced Delta-V Engineers to join our team and work onsite. The engineers will act as owners' representatives and support the existing team. This role requires expertise in ...

Job Summary: * They are interested in temperature mapping experience, specifically CTUs, stability chambers, or similar environments. Strong lab instrument experience. * 5+ years of hands-on CSV in ...

Showing results 21-40

CQV Engineer

Other

Posted 14 days ago


Job description

Summary:
The CQV Engineer will be responsible for executing commissioning, qualification, and validation testing activities in a GMP pharmaceutical manufacturing environment. This role is strictly focused on test execution, protocol execution, and documentation support for process and equipment validation. The engineer will support validation of autoclaves, parts washers, and isolator filling systems, as well as associated utilities and processes. This is a hands-on, field-based role focused on following approved protocols, generating documentation, and supporting deviation resolution.
Roles & Responsibilities:
  • Execute IQ, OQ, and PQ protocols for pharmaceutical manufacturing equipment and processes.
  • Perform hands-on test execution for:
  • Autoclaves
  • Parts washers
  • Isolator filling systems
  • Support process validation and equipment validation activities in a GMP environment.
  • Execute cycle development and cycle qualification studies for sterilization and cleaning processes.
  • Document all test results in accordance with GMP and site procedures.
  • Identify, document, and support the resolution of deviations, discrepancies, and test exceptions. Required Experience:
  • Experience in CQV, validation, or commissioning in the pharmaceutical industry.
  • Hands-on experience executing IQ/OQ/PQ protocols in a GMP environment.
  • Experience with one or more of the following systems:
  • Autoclaves
  • Parts washers
  • Isolator filling lines
  • Experience with cycle development and cycle validation is strongly preferred.
  • Strong understanding of GMP, FDA, and regulatory requirements.
  • Strong documentation and technical writing skills.