CQV Engineer

Company : Katalyst HealthCares & Life Sciences

Location : Holly Springs, NC, 27540

Posted Date : 11 October 2025

Job Details

Responsibilities:

Upstream/downstream process and CQV support (ex. autoclaves, parts washers, incubators, Isolators, HVAC).
Managing and working collaboratively with clients' quality representative to complete deviation investigation and resolution for problems and issues encountered during execution activities. Includes ability to complete root cause analysis.
Supporting clients change management program - including authoring proposed changes, executing impact assessments/ regression analysis, and supporting client documentation of change results and release.
uthoring, editing, and executing technical commissioning, qualification and validation documentation for standard equipment/systems/ software, and processes as part of team as directed by the project leader.
Running test scripts and documenting results.
dherence with project schedule for all assigned activities.
Maintaining clear, detailed records qualification and validation.
Documenting impact and risk assessments as part of a team.
Completing user interface testing, software verification, and complete alarm testing on automated systems.
Developing, reviewing, and executing testing documentation.
Making recommendations for design or process modification based on test results when executing test scripts.
Reading technical schematics to identify, locate, and test photo sensors, verify part numbers, and complete I/O testing on automated manufacturing equipment.
General understanding of capital equipment implementation and process knowledge.
Understanding validation documents, URS, IQ, OQ, PQ.
Verifying system drawings including ability to review and as-built P&IDs (piping and instrumentation drawings) and I&C (instrumentation and controls) drawings as well as verifying electrical schematics with support of an electrical engineer.

Requirements:

Bachelor of Science in Technical Field (engineering, life science, or equivalent) from accredited institution.
Minimum 4 years technical experience.
Demonstrated experience in Commissioning & Validation activities covering URS (GMP equipment).
Demonstrated experience authoring and executing FAT, SAT, IOQ, CSV Protocols.
Experience in a pharmaceutical / FDA-regulated manufacturing environment. A solid working knowledge of cGMP and facility/equipment validation requirements.
Communication Skills: Excellent oral and written communication skills, including presentations.
bility to write clearly, concisely, and persuasively in a professional environment.
Demonstrated ability to interact effectively with all levels of the organization.
Demonstrated understanding of risk-based approach to commissioning & qualification.
Experience with testing of automated manufacturing equipment / systems (e.g., PLC-controlled).
Outgoing personality with strong ability to communicate effectively with peers in clear, concise terms.
bility to work as part of a team.
Strong problem-solving and critical thinking skills.
Excellent organizational and time management skills.
Strong attention to detail.
GMP and Good Documentation Practice.
Intermediate skills with WORD (authoring/editing large technical documents with styles, tables, TOCs, track changes).
Basic skills with EXCEL and PowerPoint.
Strong interpersonal skills and clear communication capabilities.
Experience with and tolerance for high levels of challenge and change.
Experience in GMP regulated environment.
Proven attention to detail and organization in project work.
Capable of working on assigned tasks without mentorship.