CQV Engineer

Position: CQV Engineer

The Commissioning & Qualification Engineer is responsible for providing support to various upstream, downstream processes and/or manufacturing support equipment.

Responsibilities

• Work on problems of diverse scope in which analysis of data requires evaluation of identifiable factors.

• Perform systems and P&ID Walkdowns, commission equipment, and provide Equipment Turnover Packages (ETOPs)

• Spray coverage testing, cleaning verification swabbing, and sample submission practices

• Provide process engineering support for clean water systems, CIP, SIP validation risk assessments, and pharmaceutical process equipment.

• 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.

• Assist the project lead in the delivery and project management processes required to complete the project within timeline and budget.

• 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.

Desired Skills and Experience

• BS degree in chemical engineering or a related engineering or scientific discipline, or significant related experience

• Understanding of a variety of equipment including process vessels, chromatography skid/column, UF/DF skid, centrifuge, CIP, buffer preparation, glass washers and parts washers

• Experience with sterilzation

• Ability to work on complex or undefined problems and quickly identify and address critical issues.

• Ability to create an environment of trust, compliance, continuous improvement and learning.

• Demonstrated ability to manage multiple priorities with aggressive timelines.

• Effective written and 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 as needed.

Are you looking for a meaningful career that makes a difference in the world? Consider joining the Hyde Engineering + Consulting team where you will do just that. Hyde E+C contributes to helping people live longer, healthier lives by ensuring pharmaceutical and biopharmaceutical manufacturers can effectively and safely produce their life-enhancing and often life-saving medicines. To read more about Hyde's culture and benefits, visit our website: www.hyde-ec.com

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

#LI-JS1

#LI-Hybrid

Associate