Pharma CQV Engineer: Validation & Commissioning Specialist

Hyde Engineering + Consulting, Inc.; Raleigh (NC); Hybrid; USD 90,000 - 130,000; Full time

Benefits offered by this job

Equal opportunity employer

Job summary

Hyde Engineering + Consulting, Inc. seeks a Back CQV Engineer Validation Engineer in Raleigh, North Carolina. The role supports commissioning and qualification activities across process equipment, cleaning systems, isolators, HVAC and utilities, including FATs, IQ, OQ, PQ and ETOPs.

You will develop and execute test protocols, review SOPs, document deliverables, and ensure cGMP compliance while coordinating with project teams and clients; travel within the United States is expected.

Qualifications

• BS degree in chemical engineering or a related engineering or scientific discipline, or significant related experience.
• Experience with pharmaceutical manufacturing.
• Ability to create an environment of trust, compliance, continuous improvement and learning.
• Demonstrated ability to manage multiple priorities with aggressive timelines.
• Effective written communication utilizing GDP; effective oral communication skills; ability to write, type, express or exchange ideas; ability to convey information/instructions accurately.
• Ability to relate with people at all levels within an organization, including diverse cultures.
• Willingness to travel within the United States as needed.

Responsibilities

• Work on problems of diverse scope in which analysis of data requires evaluation of identifiable factors.
• Perform several activities on clean water systems, compressed gases systems, CIP, mixing and storage vessels, distribution systems, and other pharmaceutical process equipment.
• Perform systems and P&ID Walkdowns.
• Write and execute Factory Acceptance Tests (FATs), Commissioning, Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ), and cycle development protocols including development of final reports.
• Commission and qualify equipment, and provide Equipment Turnover Packages (ETOPs).
• Provide process engineering support for clean water systems, compressed gases, CIP, and pharmaceutical process equipment.
• Assist the project lead in the delivery and project management processes required to complete the project within timeline and budget.
• Promote cGMP and regulatory compliance into assigned projects.
• Review and modification of standard operating procedures (SOPs) for various equipment.
• Document, monitor, and report on project deliverables.
• Manage project documentation such as protocols, reports, calibration certificates, and process trends and be able to report findings to clients and vendors.

Education

BS in chemical engineering or related field

Experience with pharmaceutical manufacturing

Job description

Hyde Engineering + Consulting, Inc. seeks a Back CQV Engineer Validation Engineer in Raleigh, North Carolina. The role supports commissioning and qualification activities across process equipment, cleaning systems, isolators, HVAC and utilities, including FATs, IQ, OQ, PQ and ETOPs.

You will develop and execute test protocols, review SOPs, document deliverables, and ensure cGMP compliance while coordinating with project teams and clients; travel within the United States is expected.