Senior Validation Engineer

Ascend Project Management; South Dublin; Hybrid; EUR 70,000 - 95,000; Part time

Job summary

Ascend Project Management is seeking an experienced Senior Validation Engineer for a leading pharmaceutical manufacturer in South Dublin. This 12-month contract requires 3 days per week onsite, with the balance potentially set aside for remote work.

You will deliver qualification and validation activities for equipment, utilities, facilities and manufacturing systems, ensuring compliance with cGMP, regulatory requirements, and company quality standards.

Qualifications

• Bachelor's degree in Engineering, Science, or a related technical discipline.
• Minimum of 5 years' validation experience within the pharmaceutical, biotechnology, or medical device industries.
• Strong knowledge of cGMP regulations, validation principles, and qualification lifecycle activities (IQ/OQ/PQ).
• Experience with validation of equipment, utilities, facilities, manufacturing processes, or cleaning systems.

Responsibilities

• Plan, develop, review, and execute validation documentation including Validation Plans, Risk Assessments, IQ/OQ/PQ protocols, reports, and validation summary report.
• Lead and support qualification and validation activities for equipment, utilities, facilities, manufacturing processes, and capital projects.
• Maintain systems in a validated state through lifecycle management, periodic review, requalification, and change control activities.
• Collaborate with Engineering, Manufacturing, Quality Assurance, and external vendors to deliver validation activities in line with project timelines and regulatory requirements.
• Support quality systems by participating in investigations, deviations, CAPAs, risk assessments, audits, and regulatory inspections.
• Identify and implement continuous improvement opportunities to enhance validation processes, compliance, and operational efficiency.

Skills

Communication

Problem-solving

Organisation

Stakeholder management

Education

Bachelor's degree in Engineering, Science, or related technical discipline

Job description

We are working with a leading pharmaceutical manufacturing company to recruit an experienced Senior Validation Engineer. This is a 12 month contract role with 3 days per week onsite in South Dublin.

The Senior Validation Engineer will support validation activities across pharmaceutical manufacturing operations. The successful candidate will be responsible for delivering qualification and validation activities for equipment, utilities, facilities, and manufacturing systems, ensuring compliance with cGMP, regulatory requirements, and company quality standards. Working collaboratively with Engineering, Manufacturing, Quality, and cross-functional project teams, you will support new installations, system modifications, lifecycle management, and continuous improvement initiatives

Key Responsibiliti

• esPlan, develop, review, and execute validation documentation including Validation Plans, Risk Assessments, IQ/OQ/PQ protocols, reports, and validation summary report
• s.Lead and support qualification and validation activities for equipment, utilities, facilities, manufacturing processes, and capital project
• s.Maintain systems in a validated state through lifecycle management, periodic review, requalification, and change control activitie
• s.Collaborate with Engineering, Manufacturing, Quality Assurance, and external vendors to deliver validation activities in line with project timelines and regulatory requirement
• s.Support quality systems by participating in investigations, deviations, CAPAs, risk assessments, audits, and regulatory inspection
• s.Identify and implement continuous improvement opportunities to enhance validation processes, compliance, and operational efficienc

Key Requireme

• ntsBachelor's degree in Engineering, Science, or a related technical discipli
• ne.Minimum of 5 years' validation experience within the pharmaceutical, biotechnology, or medical device indust
• ry.Strong knowledge of cGMP regulations, validation principles, and qualification lifecycle activities (IQ/OQ/P
• Q).Experience with validation of equipment, utilities, facilities, manufacturing processes, or cleaning syste
• ms.Familiarity with Quality Management Systems, including change control, deviations, CAPAs, and electronic validation/document management syste
• ms.Excellent communication, problem-solving, organisational, and stakeholder management skills, with the ability to manage multiple priorities in a regulated environme