Process Commissioning & Qualification Engineer
Company Name:
Hyde Engineering
Consulting
Since 1993, Hyde has been a worldwide leader and global service provider to pharmaceutical and biopharmaceutical industries. Our projects result in the successful design, construction, commissioning, and validation of manufacturing facilities and equipment.
As a member of the Hyde team, you'll be part of providing state-of-the-art solutions for some of the industry leaders. As we continue to grow our operations around the world, we need the best talent--men and women dedicated to quality and innovation. We offer a collaborative culture, challenging projects, and excellent compensation and benefits. You will find these values reflected in our company:
Family Happiness
Integrity
Friendship
Wisdom
Adventure
The Commissioning & Qualification Engineer is responsible for providing engineering support to various areas, including media preparation, harvest capture and clarification, buffer preparation, clean-in-place systems, and manufacturing support equipment. This engineer will be involved throughout the project lifecycle, including Factory Acceptance Testing (FAT) and Commissioning and Qualification (C&Q).
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 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.
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.
Desired Skills & Experience
BS degree or higher 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
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 neededEstimated Salary: $20 to $28 per hour based on qualifications.
Hyde Engineering
Consulting
Since 1993, Hyde has been a worldwide leader and global service provider to pharmaceutical and biopharmaceutical industries. Our projects result in the successful design, construction, commissioning, and validation of manufacturing facilities and equipment.
As a member of the Hyde team, you'll be part of providing state-of-the-art solutions for some of the industry leaders. As we continue to grow our operations around the world, we need the best talent--men and women dedicated to quality and innovation. We offer a collaborative culture, challenging projects, and excellent compensation and benefits. You will find these values reflected in our company:
Family Happiness
Integrity
Friendship
Wisdom
Adventure
The Commissioning & Qualification Engineer is responsible for providing engineering support to various areas, including media preparation, harvest capture and clarification, buffer preparation, clean-in-place systems, and manufacturing support equipment. This engineer will be involved throughout the project lifecycle, including Factory Acceptance Testing (FAT) and Commissioning and Qualification (C&Q).
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 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.
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.
Desired Skills & Experience
BS degree or higher 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
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 neededEstimated Salary: $20 to $28 per hour based on qualifications.
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