Validation Engineer

Claran Consultants Ltd; Carlow; On-site; EUR 60,000 - 85,000; Full time

Job summary

Claran Consultants Ltd is seeking a Compliance Specialist (Validation) for a leading pharmaceutical company in Carlow to provide compliance support across validation activities in a cGMP environment.

You will contribute to audits, maintain validation master plans, and drive continual improvement, ensuring regulatory requirements are met and that documentation is accurate and ready for inspection.

Qualifications

• Relevant technical qualification in Applied Pharmaceutical / Biological / Chemical sciences or engineered qualification.

Responsibilities

• Provide compliance support for validation activities.
• Support Regulatory, Divisional and Internal audits.
• Maintain site Validation Master Plan.
• Generate & approve periodic revalidation plan and report.
• Generate & approve periodic review plan.
• Review validation documentation.
• Investigate & RCA support.
• Ensure compliance with QMS, regulations and company standards.

Skills

Deviation Management

Change Control

Validation Lifecycle

QMS & GMP Compliance

Communication Skills

Problem Solving

Audits

Data Analysis

Education

Applied Pharmaceutical/Biological/Chemical sciences degree

Engineering qualification

Tools

DeltaV

Pi System

MS Office

Job description

Job Description

A leading pharmaceutical company in Carlow are seeking a Compliance Specialist (Validation) for candidates interested in a new challenge in a cGMP regulatory environment. The successful candidate will provide compliance support to all areas of Validation, ensuring compliance to cGMP & regulatory requirements. Bring energy, knowledge, innovation to carry out the following:

• Provide compliance support for validation activities.
• Support Regulatory, Divisional and Internal audits.
• Respond to operational and business areas, ensuring compliance with cGMP & regulatory requirements
• Accountable for compliance via documentation completion, risk assessments, closing out corrective actions and proactively highlighting any issues around compliance
• Responsible for maintaining site Validation Master Plan
• Generation & approval of periodic revalidation plan & report
• Generation & approval of periodic review plan
• Generation & approval of validation governance report
• Generation & coordination of Annual Product Review validation chapters
• Inspection readiness coordination & support including oversight of story board preparation and ensuring GMP compliant documents are available.
• Review of validation documentation.
• Investigation & RCA support.
• Ensure compliance with the QMS, industry/company specific standards and regulations.
• Demonstrate effective communication and interpersonal skills.
• Proactively & consistently improve personal knowledge and capability.
Demonstrate an awareness of own capabilities and development needs.
• Support continuous improvement by active participation in, and contribution to, projects and problem-solving including use of MPS processes and tools.
• Participate in driving a high performing & inclusive culture, stimulating personal growth & development.
• Work collaboratively to drive a safe and compliant culture in Carlow.
• May be required to perform other duties as assigned

What skills you will need:

In order to excel in this role, you will more than likely have considerable experience in a comparable role, with experience operating as individual contributor adding value to the business in a GMP manufacturing setting, as well as the following qualifications/skills:

• Relevant technical qualification(s) in Applied Pharmaceutical / Biological / Chemical sciences or applied Technical / Engineering qualification, the successful candidate will also have a proven track record in delivering excellence.
• Exception / Deviation Management and Change Control.
• Equipment Periodic Validation Equipment Validation Lifecycle Project Management Skills/Qualification Knowledge of process monitoring systems, automation systems (DeltaV), operational intelligence & data systems (Pi System) within a GMP manufacturing environment would be beneficial and desirable Evidence of continuous professional development is desirable.
• Knowledge of regulatory/code requirements to Irish, European and International Codes, Standards and Practices.
• Ability to analyse and interpret complex data, and link to equipment performance and out of specification findings as appropriate.
• Report, standards, policy writing skills required.
• Equipment and process validation.
• Sterile Fill-Finish processes and equipment.
• Proficiency in Microsoft Office and job-related computer applications required Excellent communication, presentation and interpersonal skills, to interface effectively with all levels of colleagues and with external customers in a team orientated manner.

Knowledge and experience of the below areas will be considered advantageous

• Autoclave/SIP Sterilisation Validation
• Dry Heat Sterilisation
• Isolator VHP/HVAC Qualification
• Controlled Temperature Units/Equipment Qualification
• Validation of Tank CIP & Parts Washers for in-process components.
• Cleaning recovery studies using TOC and swab methods.
• CCI qualification.
• Shipping Qualification.
• Filter Validation.
• Vial and Syringe Processing Technologies

The successful candidate will be required to work both independently and in a cross functional team to accomplish validation compliance objectives. Works with moderate work direction and is skilled and knowledgeable to the position. Skills: Equipment and process validation Sterile Fill-Finish TPBN1_IJ