Validation Engineer

We are currently looking for a Qualification & Validation Engineer – Process Performance Qualification to join a leading biopharmaceutical company based in the County Waterford area. As the Qualification & Validation Engineer – Process Performance Qualification, you will be responsible for ensuring that processes consistently produce products meeting predetermined specifications and quality attributes.

This is an initial 12 month contract with possible extension.


KEY DUTIES AND RESPONSIBILITIES:

Your duties as the Qualification & Validation Engineer – Process Performance Qualification will be varied; however, the key duties and responsibilities are as follows:

1. As the Qualification & Validation Engineer, you will author, review, and execute PPQ protocols and reports in alignment with global standards and regulatory expectations.

2. As the Qualification & Validation Engineer, you will define PPQ strategy, including batch numbers, sampling plans, acceptance criteria, and statistical approaches.

3. As the Qualification & Validation Engineer, you will contribute to the development and maintenance of the Process Validation Master Plan (PVMP).

4. As the Qualification & Validation Engineer, you will support lifecycle management changes requiring PPQ, including technology transfers and post-approval changes.


ROLE REQUIREMENTS:

To be successful in your application to this exciting role as the Qualification & Validation Engineer, we are looking to identify the following on your profile and past history:

1. Relevant degree in a science or engineering discipline.

2. Proven industry experience in pharmaceutical manufacturing, process validation, or quality assurance in a regulated GMP environment.

3. A working knowledge and practical experience with Process Performance Qualification (PPQ) design, execution, and reporting.

Key Words: Qualification & Validation Engineer / Process Performance Qualification / PPQ / biopharmaceutical / Co Waterford / process validation / GMP / FDA / EMA / ICH guidelines / quality assurance / pharmaceutical manufacturing / validation protocols 

Hyper Recruitment Solutions Ltd (HRS) is an Equal Opportunities employer. We welcome applications from anyone who meets the role requirements. HRS exclusively supports the Life Science sectors, combining recruitment expertise with scientific knowledge to help you advance your career.
 

Hyper Recruitment Solutions Ltd (HRS) is an Equal Opportunities employer. We welcome applications from anyone who meets the role requirements. HRS exclusively supports the STEM sectors, combining recruitment expertise with scientific knowledge to help you advance your career.