Quality Assurance Validation Specialist

Insight Global; Boston (MA); On-site; USD 55,104 - 75,768; Full time

Job summary

An established industry player in pharmaceutical manufacturing is seeking a motivated Engineer to join their dynamic team. In this role, you will be actively involved in the commissioning, qualification, validation, and requalification activities for cutting-edge Cell and Gene Therapy facilities. Your expertise will ensure compliance with global standards and cGMP guidelines while collaborating with various stakeholders to drive project success. This is a fantastic opportunity to contribute to innovative projects and enhance your professional growth in a supportive environment. If you are ready to take on challenges and make a significant impact, we encourage you to apply!

Qualifications

• Bachelor’s degree in Engineering or related field required.
• 2-4 years of experience in Commissioning, Qualification, and Validation.

Responsibilities

• Develop and execute qualification and validation test plans and protocols.
• Coordinate with personnel and vendors to schedule and execute test plans.

Skills

Technical Problem Solving

Troubleshooting Skills

Cross-Functional Collaboration

Adaptability to Change

Education

Bachelor’s degree in Engineering

2-4 years of CQV experience

Tools

Kaye Validator

Data Loggers

Job description

This range is provided by Insight Global. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more.

Base pay range

$40.00/hr - $55.00/hr

The Engineer is actively involved in Commissioning, Qualification, Validation, and Requalification activities for Cell and Gene Therapy facilities. The individual is responsible for executing qualification protocols at the client’s facilities and collaborating with Global Engineering, Facilities Operations, GIS, QA, and PMO throughout the life cycle of the project.

This position reports directly to the Manager of Validation.

Key Responsibilities:

1. Develops and executes qualification and validation test plans and protocols.
2. Ensures that all validation documents align with the current SOPs, global standards and cGMP guidelines.
3. Coordinates with personnel onsite and other vendors to schedule and execute test plans.
4. If required, coordinates with the construction team and operations teams to schedule execution of validation activities, safely and effectively.
5. Effectively works with cross functional departmental stakeholders, PMO, GIS, EH&S, Global Security, design teams, EHS and QA.
6. Supports right-the-first-time culture for all documents distributed across the organization.
7. Ensures the Global Engineering reputation and partnership is flourished with the cross-functional teams.
8. Receptive to change – Adapts (quickly) to changing circumstances.
9. Minimum Bachelor’s degree in an Engineering (Chemical, Biomedical, Industrial, Biotechnology) or related discipline with 2-4 years of CQV experience or equivalent professional experience.
10. Self-motivated and must be able to work independently with minimal supervision and direction.
11. Experience in developing and executing protocols in GMP industry.
12. Experience using Kaye Validator and Data loggers.
13. Understanding and application of technical principles, theories, and concepts in the field, GMP, ISO, GAMP, ANSI.
14. Ability to learn and demonstrate technical problem solving and troubleshooting skills.

*Pay Range is $40-55/hr Depending on Years of experience, education, and other factors*

Seniority level

Associate

Employment type

Contract

Job function

Industries: Pharmaceutical Manufacturing