Validation Engineer

Servier Group; Ireland; On-site; EUR 55,000 - 75,000; Full time

Job summary

Servier Group in Ireland seeks a Validation Engineer in the Quality division to coordinate, execute and report Process, Transport and Cleaning Validation activities, and to support equipment, facility and utility qualifications. You will prepare protocols, maintain validation documentation and support audits, root cause investigations and improvements to stay in a validated state.

The role requires 2–3 years of validation experience, a science or engineering degree, GMP exposure and strong

Qualifications

• Minimum 2–3 years validation experience.
• Third level degree in a Scientific or Engineering Discipline.
• Good knowledge of validation procedures and execution.
• Pharmaceutical experience.
• Experience in a GMP regulated environment.

Responsibilities

• Coordinate, execute and report Process, Transport and Cleaning Validation activities.
• Support equipment/system/facility/utility and laboratory qualification activities.
• Protocol preparation and Report writing.

Skills

Validation expertise

Process validation

GMP experience

Communication skills

Organisational skills

Education

Science/Engineering degree

Job description

As part of the Validation team within Quality, the Validation Engineer will be responsible for the co‑ordination, execution and reporting of Process, Transport and Cleaning Validation activities, along with supporting equipment/system/facility and utility qualifications.

Responsibilities

Key responsibilities will include, but are not limited to:

• Responsible for the co‑ordination, execution and reporting of Process, Transport and Cleaning Validation activities
• Supporting equipment/system/facility/utility and laboratory qualification activities
• Protocol preparation and Report writing.
• Coordinate and report on cleaning monitoring, ongoing process verifications and equipment requalification activities ensuring that processes and equipment remain in a validated state
• Execution of cleaning verification activities
• Support Industrial Transfers, Internal Transfers and Optimisations
• Assist in the preparation and carry out reviews of IQ / OQ / PQ documentation for the validation of equipments and systems
• Responsible for Investigating and resolving non‑conformances and deviations associated with validation studies.
• Work closely with and co‑ordinate the work of the persons responsible for validation in various departments and ensure the Company’s validation policies are respected.
• Ensure all products/processes/equipment/systems are validated/qualified as per site procedures and policy.
• Define the contents and ensure the control of validation documentation.
• Adhere to the Change Management and Quality Management system procedures.
• Ensure Registration compliance.
• Support Root Cause Problem Solving and Risk Assessments.
• Prepare, review and maintain SOP’s /Policies/Validation Master Plan detailing the company validation strategy.
• Perform Training for Validation activity execution and implementation.
• Contribute to achievement of the Validation Master Plan Project schedule and site KPI.
• Keep up to date on current industry practices and regulatory expectations.
• Support internal and external audit and inspections

Requirements

Requirements for the position:

• Minimum 2-3 years validation experience
• A Third level degree in a Scientific or Engineering Discipline or equivalent.
• A good knowledge of validation procedures and execution.
• Pharmaceutical experience
• Strong Communication and organisational skills
• Experience in a GMP regulated environment