Validation Engineer (Arklow, Co.Wicklow, IE)

Biopharma Careers; Arklow; On-site; EUR 45,000 - 65,000; Full time

Job summary

Servier Ireland is seeking a Validation Engineer within the Quality Validation team to coordinate, execute and report Process, Transport and Cleaning Validation activities across site operations. You will prepare and review IQ/OQ/PQ documentation, support equipment and facility qualifications, and ensure all validation activities align with site procedures and regulatory expectations.

The role requires GMP experience, strong writing and communication skills, and the ability to work

Qualifications

• 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.
• Good IT skills
• Excellent writing skills

Responsibilities

• Coordinate, execution and reporting of Process, Transport and Cleaning Validation activities.
• Support 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.
• Execute cleaning verification activities.
• Support Industrial Transfers, Internal Transfers and Optimisations.
• Prepare, review and maintain IQ/OQ/PQ documentation for validation of equipment and systems.
• Investigate and resolve non-conformances and deviations associated with validation studies.
• Work with validation teams across departments to ensure compliance with site procedures.

Skills

Validation experience

GMP experience

Communication skills

Writing skills

IT skills

Education

Third level degree in Scientific or Engineering Discipline

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

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 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
• Good I.T. skills
• Excellent Writing Skills

Whatever your area of expertise, your work within the Servier Group helps advance therapeutic progress for the benefit of patients. You will be part of teams recognized for their scientific excellence and reach your full potential in a professional environment that encourages you to develop yourself. Tailor-made onboarding journeys, mobility opportunities, quality trainings, responsible management, team spirit... All this and more in a workplace focused on your well-being.

At Servier, we are committed to therapeutic progress to serve patient needs. We put the diversity of our employees as a source of richness for the fulfillment of this vocation.