Computer System Validation Engineer
liverpool, england, United Kingdom
About the Position :
Location: Liverpool, England ( Onsite )
Are you ready to join a world leader in the exciting and dynamic fields of the Pharmaceutical and Medical Device industries ? PQE Group has been at the forefront of these industries since 1998 , with 40 subsidiaries and more than 2000 employees in Europe, Asia and the Americas .
Following a new opportunity, we are looking for many CSV Engineer Consultants to join our CSV Team based in Liverpool, England.
You will be responsible for:
Develop and execute validation protocols for computer software systems used in automated process manufacturing equipment, with a specific focus on DeltaV-controlled systems.
Collaborate with engineering, operations, and quality assurance teams to define validation requirements, ensuring alignment with regulatory standards (e.g., FDA, GMP).
Perform risk assessments and gap analyses to identify potential areas of concern in the validation process, proposing and implementing mitigation strategies as needed.
Generate validation documentation, including validation plans, protocols, reports, and traceability matrices, adhering to established procedures and guidelines.
Conduct testing and verification activities, including software installation qualification (SIQ), operational qualification (OQ), and performance qualification (PQ), in accordance with approved protocols.
Troubleshoot and resolve validation issues, working closely with technical teams to address any discrepancies or deviations encountered during testing.
Maintain validation documentation in a compliant and organized manner, ensuring traceability and accessibility for audits and regulatory inspections.
Stay informed about industry trends, regulatory updates, and advancements in validation methodologies, incorporating best practices into our validation processes.
Provide technical guidance and mentorship to junior validation engineers, fostering a culture of excellence and continuous improvement within the validation team.
About you:
Bachelor's degree in Engineering, Computer Science, or related field. Advanced degree preferred.
8-10 years of experience in computer software validation, with a focus on automated process manufacturing equipment, particularly DeltaV-controlled systems .
Proficiency in validation principles and methodologies, with hands-on experience in executing validation protocols in a regulated environment (e.g., FDA, GMP).
In-depth knowledge of DeltaV automation platform , including configuration, programming, and troubleshooting capabilities.
Familiarity with regulatory requirements and standards governing automated process manufacturing, such as 21 CFR Part 11, GAMP 5, and IEC 62304.
Strong analytical and problem-solving skills, with the ability to assess complex technical issues and propose effective solutions.
Excellent communication and interpersonal skills, with the ability to collaborate effectively with cross-functional teams and stakeholders.
Detail-oriented mindset with a focus on accuracy and compliance in validation documentation and processes.
Proven track record of successfully leading validation projects and delivering results on schedule and within budget.
Next Steps
Upon receiving your application, if a match is found, the Recruiting department will contact you for an initial HR interview.
If there's a positive match, a technical interview with the Hiring Manager will be arranged.
In the case of a positive outcome coming from Hiring Manager interview, recruiter will contact you for further steps or to discuss our proposal.
Alternatively, if the outcome is negative, we will contact you to halt the recruitment process.
Working at PQE Group
As a member of the PQE team, you will be part of a challenging, multicultural company that values collaboration and innovation . PQE Group gives you the opportunity to work on international projects , improve your skills and interact with colleagues from all corners of the world.
If you are looking for a rewarding and exciting career , PQE Group is the perfect place for you.
Apply now and take the first step towards an amazing future with us.