Onsite CQV Engineer - GMP Validation Specialist (6-Month)

Intellectt INC

Massachusetts

On-site

USD 41,000 - 55,000

Part time

7 days ago
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Job summary

Intellectt INC is seeking a CQV Engineer to support commissioning, qualification, and validation activities for pharmaceutical manufacturing systems in Massachusetts. This contract role is onsite for 6 months+ and requires close collaboration with Engineering, Quality, Manufacturing, and Validation teams to ensure systems are properly commissioned, qualified, and compliant with GMP requirements.

Responsibilities include executing CQV activities for equipment and utilities, developing and

Qualifications

  • 3+ years of CQV/ C&Q experience in pharma manufacturing.
  • Hands-on IQ/OQ/PQ and qualification knowledge.
  • Experience with P&IDs, drawings, and equipment specs.
  • Strong GMP and validation practices.
  • Excellent cross-functional communication.

Responsibilities

  • Execute commissioning and qualification activities for pharmaceutical manufacturing equipment, utilities, and systems.
  • Develop, review, and execute C&Q protocols (IQ/OQ/PQ).
  • Perform field verifications, walkdowns, and inspections against P&IDs.
  • Support validation plans, test scripts, protocols, reports, turnover.
  • Manage punch lists, deviations, and turnover documentation.
  • Collaborate with Engineering, Quality, Manufacturing, Automation, and vendors.
  • Ensure CQV activities comply with cGMP and regulatory requirements.

Skills

CQV experience
GMP knowledge
Cross-functional collaboration
Documentation proficiency

Education

Bachelor's degree in Engineering, Life Sciences, or related technical discipline

Job description

Intellectt INC is seeking a CQV Engineer to support commissioning, qualification, and validation activities for pharmaceutical manufacturing systems in Massachusetts. This contract role is onsite for 6 months+ and requires close collaboration with Engineering, Quality, Manufacturing, and Validation teams to ensure systems are properly commissioned, qualified, and compliant with GMP requirements.

Responsibilities include executing CQV activities for equipment and utilities, developing and

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