CSV Validation Engineer

Company Details Confidential; Tipperary; On-site; EUR 80,000 - 100,000; Full time

Job summary

A confidential company in Co. Tipperary is seeking a QA Validation Engineer. The role includes ensuring the qualification of equipment, computerized systems, facilities, and utilities in compliance with regulatory requirements. The ideal candidate will have a minimum of 5 years of experience in the pharmaceutical industry and will be responsible for reviewing and approving validation plans, coordinating with personnel, and investigating qualification deficiencies. This position requires teamwork, initiative, and time management skills.

Qualifications

• Minimum 5-year experience in pharmaceutical industry accredited by HPRA and FDA.

Responsibilities

• Review qualification/re‑qualification and validation activity of equipment, system, facility, and plant utilities.
• Support execution of qualification/re‑qualification and validation activity.
• Review and approval of project validation plans.
• Coordinate with manufacturing/engineering personnel for respective qualification/validation activities for timely completion.
• Investigate deficiencies related with qualification activities and determine corrective actions.
• Review SOPs and drawings as related to validation.
• Review and approval of calibration and PM activities as related to validation.
• Review and approval of studies/risk assessments/investigations related to qualification.
• Participate in investigations that may impact the qualified state of equipment, systems, facilities or utilities.

Skills

Teamwork

Time management

Initiative

Education

Science graduate

Job description

Job Title

CSV Validation Engineer

Location: Co. Tipperary

Application Details

In order to work in Ireland a non-EEA National, unless they are exempted, must hold a valid employment permit. Please review the Eligibility and requirements for an employment permit if you are unsure of your eligibility to apply for this vacancy.

Job Description

QA Validation role to ensure qualification of equipment, computerised systems, facilities and utilities is performed in compliance with regulatory requirements, company policy and procedures.

Responsibilities

• Review qualification / re‑qualification and validation activity of equipment, system, facility, and plant utilities.
• Support execution of qualification / re‑qualification and validation activity.
• Review and approval of project validation plans.
• Coordinate with manufacturing / engineering personnel for respective qualification / validation activities for timely completion.
• Investigate deficiencies related with qualification activities and determine corrective actions.
• Review SOPs and drawings as related to validation.
• Review and approval of calibration and PM activities (e.g., schedules) and work orders as related to validation.
• Review and approval of studies/risk assessments/investigations related to qualification.
• Participate in investigations that may impact the qualified state of equipment, systems, facilities or utilities.

Qualifications

• Science graduate with minimum 5‑year experience in pharmaceutical industry accredited by HPRA and FDA.

Career Level

• Experienced [Non-Managerial]

Candidate Requirements

Essential

• Minimum 5 years experience.
• No qualification required.

Desirable

• Skill in trade(s) or technical IT.
• Teamwork, time management, initiative.