CQV Engineer Consultant - All Levels

ELIQUENT Life Sciences, Inc.; North Carolina; On-site; USD 80,000 - 120,000; Full time

Job summary

ELIQUENT Life Sciences, Inc. is seeking a CQV Engineer to support commissioning, qualification, and validation activities for pharmaceutical and medical device projects across the U.S.

You will develop protocols, SOPs, and risk mitigations, collaborating with cross-functional teams to meet client timelines while upholding GMP standards and regulatory guidance. Travel to client sites is expected based on project needs.

Qualifications

• BS in Engineering, Science or equivalent technical degree.
• Solid understanding of GMP regulations and industry standards.
• Experience in commissioning, qualification, and validation within the pharmaceutical and/or medical device industry commensurate with the level of the project demand.
• Excellent communication and interpersonal skills.
• Ability to work independently and collaboratively in a dynamic team environment.
• Clients based throughout the U.S. so ability to work away from home highly preferred

Responsibilities

• Develop and execute commissioning, qualification, and/or validation protocols for equipment, utilities, and/or facilities in accordance with industry regulations and client specifications.
• Contribute to the development and revision of SOPs related to CQV processes and ensure that SOPs are in compliance with regulatory requirements and industry best practices.
• Work collaboratively with project teams to integrate CQV activities seamlessly into project timelines.
• Provide regular updates through technical presentations on the status of validation activities to project teams and stakeholders.
• Uphold high standards of quality in project execution, ensuring compliance with GMP (Good Manufacturing Practices) and regulatory guidelines.
• Identify and assess risks associated with CQV activities and develop mitigation strategies.

Skills

CQV experience

Communication skills

Team collaboration

Independent work

GMP knowledge

Problem solving

Travel readiness

Education

BS in Engineering or Science

Job description

ELIQUENT Life Sciences is the leading global consulting firm providing solutions to life science companies researching, developing, and manufacturing innovative products to serve patients and respond to public health challenges around the world. ELIQUENT is committed to serving clients’ needs with extensive expertise, unwavering integrity, and strategic insight in a manner that supports availability of safe, effective, and high-quality drugs, biologics, and medical devices. For more information, please visit our website at www.eliquent.com.

As a CQV Engineer at Eliquent Life Sciences, you will play a crucial role in ensuring the successful commissioning, qualification, and validation of processes, systems, and equipment for our clients in the Life Sciences sector. We are seeking project-based consultants at various experience levels to support our growing pipeline of projects on the West Coast, Midwest, and East Coast of the United States. Whether you are a seasoned professional or just starting your career in CQV, we welcome diversity in experience and expertise.

The following is a short list of the typical responsibilities and deliverables of any given project:

• Develop and execute commissioning, qualification, and/or validation protocols for equipment, utilities, and/or facilities in accordance with industry regulations and client specifications.
• Contribute to the development and revision of Standard Operating Procedures (SOPs) related to CQV processes and ensure that SOPs are in compliance with regulatory requirements and industry best practices.
• Work collaboratively with project teams to integrate CQV activities seamlessly into project timelines.
• Provide regular updates through technical presentations on the status of validation activities to project teams and stakeholders.
• Uphold high standards of quality in project execution, ensuring compliance with GMP (Good Manufacturing Practices) and regulatory guidelines.
• Identify and assess risks associated with CQV activities and develop mitigation strategies.

Qualifications

• BS in Engineering, Science or equivalent technical degree.
• Solid understanding of GMP regulations and industry standards.
• Excellent communication and interpersonal skills.
• Ability to work independently and collaboratively in a dynamic team environment.
• Experience in commissioning, qualification, and validation within the pharmaceutical and/or medical device industry commensurate with the level of the project demand.
• Strong analytical and problem-solving skills with attention to detail.
• Clients based throughout the U.S. so ability to work away from home highly preferred