Quality Validation Engineer

Morgan McKinley; Munster; On-site; EUR 41,000 - 55,000; Full time

Job summary

Morgan McKinley is seeking a Quality Validation Specialist for a Pharmaceutical company in Tipperary on a 12-month hourly-rate contract. The role focuses on leading Validation Master Plans, executing equipment, process, and facility validations, and ensuring timely completion in collaboration with manufacturing teams.

The candidate will review SOPs related to Cleaning Validation, assess risk studies, and qualify QA equipment while supporting day-to-day QA validation activities as required by the

Qualifications

• Minimum 3+ years experience in Quality Validation within Pharmaceuticals or Medical Devices.
• Bachelor's Degree in Engineering or a related technical field.

Responsibilities

• Prepare and review Validation Master Plan and Project Validation Plans and closure reports.
• Execute, review and approve Qualification / Validation activities for Equipment / System / Facility and Plant utilities.
• Coordinate with manufacturing for timely Qualification / Validation activities.
• Prepare and review SOPs related to Cleaning Validation.
• Prepare, review, execute, and approve studies / risk assessments related to Equipment / Process / Facility / System.
• Procurement and qualification of QA equipment as required.
• Carry out other duties as assigned by Head of Department.

Skills

Quality Validation

Coordination

Education

Bachelor's degree in Engineering or related technical field

Job description

We are looking for a Quality Validation Specialist to join a Pharmaceutical Company in Tipperary. This is a 12 month hourly rate contract position.

Requirements:

• Responsible for preparation and review of Validation Master Plan and Project Validation Plans and closure reports.
• Responsible for execution, review and approval of Qualification / Re-Qualification and Validation activity of Equipment / System / Facility and Plant utilities as QA Validation.
• Responsible to co-ordinate with manufacturing personnel for respective Qualification / Validation / Re-qualification activity for timely completion of activities.
• Responsible for preparation and review of SOPs related to Cleaning Validation.
• Responsible for preparation, review, execution, and approval of studies / risk assessments / related to Equipment / Process / Facility / System as QA Validation.
• Responsible for procurement and qualification of QA equipment as required.
• Activities other than those defined in the job description are to be carried out, as per the requirement of Head of Department and by following Head of Department’s (or approved deputy) instructions.
• In absence of the employee named above, the designated QA Validation person is responsible for day-to-day activities/duties.

Skill, Attributes, Experience:

• Minimum 3+ years experience in Quality Validation with a background in Pharmaceuticals or Medical Device.
• Bachelor's Degree in Engineering or a related technical field.