Validation Engineer

Sigmar Recruitment; Roscommon; On-site; EUR 52,000 - 78,000; Full time

Job summary

Sigmar Recruitment is helping a Roscommon-based pharmaceutical manufacturer recruit a Validation Engineer on a 2-year fixed-term contract. The role covers equipment qualification (IQ/OQ/PQ), process and cleaning validation, and CSV activities within a GMP environment.

You will work cross-functionally with Quality, Engineering and Production to ensure timely delivery of validation activities, maintain documentation, and support audits.

Qualifications

• Experience as a Validation Engineer in a pharmaceutical GMP setting.
• Strong knowledge of equipment, process and cleaning validation (IQ/OQ/PQ).
• Good GMP understanding and documentation skills.

Responsibilities

• Support and manage equipment qualification activities (IQ/OQ/PQ).
• Coordinate process and cleaning validation activities.
• Support CSV activities.
• Maintain Validation Master Plan, protocols, reports and SOPs.
• Support calibration programme and related docs.
• Investigate validation-related deviations and support CAPA.
• Assist qualification of new equipment and reviews.
• Provide validation support during audits by regulators and customers.
• Collaborate with Quality, Engineering and Production to meet timelines.

Skills

GMP compliance

Equipment qualification

Technical writing

Communication

Job description

Validation Engineer | Roscommon | 2-Year FTC

About Your New Employer

An established pharmaceutical manufacturing company in Co. Roscommon is looking to recruit a Validation Engineer on a 2-year fixed-term contract.

This is a hands-on role within a regulated GMP pharmaceutical environment, with responsibility across a broad range of site validation activities.

About Your New Job

As a Validation Engineer, you will:

• Support and manage equipment qualification (IQ/OQ/PQ) activities, including protocols and reports.
• Coordinate process and cleaning validation activities.
• Support Computer System Validation (CSV) activities.
• Maintain validation documentation, including the Validation Master Plan, protocols, reports and SOPs.
• Support the site's calibration programme and associated documentation.
• Investigate validation-related deviations and support CAPA and change control.
• Support qualification of new equipment and periodic equipment reviews.
• Provide validation support during regulatory and customer audits.
• Work with Quality, Engineering and Production to deliver validation activities to agreed timelines.

What You Need

• Previous Validation Engineer experience within a pharmaceutical GMP environment.
• Strong knowledge of equipment, process and cleaning validation, including IQ/OQ/PQ.
• Good understanding of GMP, validation documentation and calibration.
• Strong technical writing, organisational and communication skills.