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Senior CQV Engineer/Validation Engineer

KPG 99 Inc.United States🇺🇸United StatesPosted 9 Jul 2026

Quick Overview

Work Type
On Site
Level
Mid Senior

Job Description

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 expertise, strong project coordination skills, and a thorough understanding of FDA and cGMP compliance requirements. The Senior CQV Engineer will work cross-functionally with Engineering, Quality, Manufacturing, Automation, and external vendors to ensure successful project execution and operational readiness within fast-paced life sciences environments.

Key Responsibilities
  • Lead and execute CQV activities for pharmaceutical and biotech capital projects.
  • Develop and execute:
    • Commissioning plans
    • IQ/OQ/PQ protocols
    • Validation test scripts
    • Traceability matrices
    • Summary reports
  • Support startup and qualification of:
    • Process equipment
    • Clean utilities
    • HVAC systems
    • Manufacturing suites
    • Automation and control systems
  • Coordinate field execution activities with engineering, construction, vendors, and operations teams.
  • Perform system walkdowns and turnover package reviews.
  • Support deviation investigations, CAPAs, and change control activities.
  • Ensure all validation documentation complies with cGMP, FDA, ISPE, and GAMP guidelines.
  • Participate in FAT/SAT execution and acceptance activities.
  • Support project schedule development and milestone tracking.
  • Collaborate with Quality Assurance and Manufacturing teams to support inspection readiness and successful system release.
  • Mentor junior CQV engineers and validation specialists as needed.

Details:

Required Qualifications
  • Bachelor's degree in Engineering, Life Sciences, Biotechnology, or related technical discipline.
  • 5-10+ years of CQV, validation, or pharmaceutical engineering experience within GMP-regulated environments.
  • Strong knowledge of:
    • cGMP regulations
    • FDA validation requirements
    • ISPE Baseline Guides
    • GAMP 5 principles
  • Experience executing commissioning and qualification for:
    • Process equipment
    • Utilities
    • HVAC systems
    • Cleanrooms
    • Automation systems
  • Experience authoring and reviewing validation lifecycle documentation.
  • Strong technical writing and documentation skills.
  • Ability to work independently within fast-paced project environments.
Preferred Qualifications
  • Experience in biologics, sterile manufacturing, fill-finish, or aseptic processing environments.
  • Previous consulting experience within life sciences industries preferred.
  • Familiarity with:
    • DeltaV
    • MES systems
    • SCADA platforms
    • Kneat or electronic validation systems
  • PMP certification or equivalent project leadership experience is a plus.
  • Strong client-facing communication and leadership skills.
Additional Skills & Competencies
  • Excellent organizational and multitasking abilities
  • Strong problem-solving and analytical skills
  • Ability to manage multiple priorities and deadlines
  • Comfortable working in both office and field environments
  • Ability to travel to client sites as required

Thanks and Regards,

Shubham Jaiswal| Team Lead Recruitment | KPG99,INC | MBE Certified Firm

3240 E State St EXT , Hamilton, NJ 08619
Direct: | |

Linkedln:

Skills

SCADA
HVAC

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