Commissioning Qualification Engineer

Hyde Engineering + Consulting; Boulder (CO); On-site; USD 75,000 - 110,000; Full time

Job summary

Hyde Engineering + Consulting seeks a Commissioning & Qualification Engineer in Boulder, CO. The role supports process equipment, clean water and CIP systems, and oversees FAT, IQ, OQ, PQ activities and ETOPs.

Responsibilities include documenting deliverables, coordinating protocols, reports and calibration certificates, and ensuring cGMP compliance. Travel within the United States is expected.

Qualifications

• BS degree or higher in chemical engineering or related field, 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; convey information accurately.
• Ability to relate with people at all levels and diverse cultures.
• Willingness to travel within the United States as needed.

Responsibilities

• Support process equipment, cleaning systems, fill/finish equipment, isolators, utilities, HVAC, monitoring systems and facilities.
• Perform tests and reviews including FAT, IQ, OQ, PQ and cycle development protocols and final reports.
• Commission and qualify equipment; provide ETOPs.
• Provide process engineering support for clean water systems, CIP and pharmaceutical process equipment.
• Assist the project lead in delivery and project management to meet timeline and budget.
• Promote cGMP and regulatory compliance on projects.
• Review and modify SOPs for various equipment.
• Document, monitor and report project deliverables; manage protocols and calibration certificates.

Skills

Written comms

GDP compliance

Project coordination

Cross-functional collab

Education

Bachelor's in chemical eng or related

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 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

Salary range: $75-110K annually, DOE

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