CQV Engineer

Hyde Engineering + Consulting; Raleigh (NC); On-site; USD 110,000 - 140,000; Full time

Job summary

Hyde Engineering + Consulting seeks a Commissioning & Qualification Engineer to support pharmaceutical facilities across FAT, IQ/OQ/PQ, and ETOPs. You'll work on clean water systems, CIP, and process equipment integration within project lifecycles.

Requires a degree in chemical engineering or related field, pharma manufacturing experience, strong documentation skills, and ability to travel within the U.S. to meet timelines.

Qualifications

• BS degree or higher in chemical engineering or related discipline.
• 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 and verbal communication; GDP compliance.
• Ability to relate with people at all levels within an organization; cross-cultural collaboration.
• 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 activities on clean water systems, CIP, and pharmaceutical process equipment.
• Write and execute FATs, IQ, OQ, PQ, and development of final reports; cycle development protocols.
• Commission and qualify equipment, provide ETOPs.
• Provide process engineering support for clean water systems, CIP, and related equipment.
• Assist the project lead in delivery and project management to meet timelines and budget.
• Promote cGMP and regulatory compliance in assigned projects.
• Review and modify SOPs for equipment; document and report project deliverables.
• Manage project documentation such as protocols, reports, calibration certificates, and process trends.

Skills

Pharma manufacturing experience

GDP documentation

Project/time management

Interpersonal skills

Travel willingness

Education

B.S. in Chemical Engineering or related discipline

Job description

TheCommissioning & Qualification Engineeris responsible for providing engineering support to various areas, including process equipment, cleaning systems, fill/finish equipment, isolators, utilities, HVAC, monitoring systems and facilities. This role will be involved throughout the project lifecycle, including Factory Acceptance Testing (FAT), construction support, and Commissioning and Qualification (C&Q).

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. Major activities include the following:
• 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

Desired Skills And Experience

• BS degree or higher 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

Hyde Engineering + Consulting is an equal opportunity, affirmative action employer

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