Qualification Engineer

The Qualification Engineer will play a crucial role in ensuring that the new pharmaceutical manufacturing facility meets all regulatory and quality standards. The successful candidate will be responsible for the development, execution, and documentation of qualification protocols, including Equipment Qualification (EQU), Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).

Key Responsibilities

Qualification Activities: Develop and execute qualification protocols for equipment, systems, and processes in accordance with regulatory requirements and industry standards.
Documentation: Prepare and review qualification documentation, including protocols, reports, and summaries, ensuring accuracy and compliance with GMP (Good Manufacturing Practice) guidelines.
Collaboration: Work closely with project managers, engineers, and vendors to ensure that all equipment and systems are installed and function according to design specifications and regulatory requirements.
Risk Management: Identify and mitigate risks associated with equipment and process qualification, providing recommendations for corrective and preventive actions.
Training: Provide training and guidance to facility personnel on qualification processes and GMP compliance.
Continuous Improvement: Monitor and review qualification processes and procedures to identify areas for improvement and ensure the facility remains compliant with evolving regulations and standards.
Compliance: Ensure that all activities adhere to company policies, regulatory requirements, and industry best practices.

Requirements

Qualifications

Bachelor’s degree in Engineering, Life Sciences, or a related field. Advanced degrees or certifications (e.g., ASQ, CQE) are a plus.
Minimum of 10 years of experience in qualification and validation within a pharmaceutical or biotech manufacturing environment.
Strong knowledge of GMP, FDA regulations, and qualification processes. Experience with qualification of pharmaceutical manufacturing equipment and systems is required.
Strong written and verbal communication skills, with the ability to clearly convey technical information to various stakeholders.
High attention to detail and accuracy in documentation and execution of qualification activities.

Soft Skills

Cross-Cultural Communication
Adaptability and Flexibility
Team Collaboration and Interdisciplinary Skills
Problem-Solving and Critical Thinking
Emotional Intelligence
Time Management and Prioritization
Ethical Awareness and Sustainability Focus
Conflict Management
Stakeholder Engagement
Continuous Learning Mindset

Share this job

General Information

Vacancy: 014

Location: Europe

Contract type: 1 year rolling contract, consulting contract.

Project duration: 1-2 years.

How to Apply?

If you’re interested in this role, we’re looking forward to hear from you! Kindly apply via the JTR Consultancy Services website with your CV in Word Document version – one of our Business Development Managers will be in touch with you shortly.