Validation Specialist Cleaning

T-pro; The Municipal District of Carlow; On-site; EUR 60,000 - 80,000; Full time

Job summary

A leading technology company in Carlow is seeking a Validation Senior Engineering Specialist to lead validation activities and ensure compliance with regulations. The ideal candidate will have 4-5 years of related experience with a strong background in validation and engineering. Key responsibilities include planning validation studies and supporting regulatory submissions. The role offers full-time employment with opportunities for professional development.

Qualifications

• 4-5 years experience in pharmaceutical or biotechnology industry.
• Experience in coaching and mentoring within validation.
• Knowledge of regulatory requirements for Irish and International codes.

Responsibilities

• Lead validation activities and maintain compliance.
• Plan and oversee validation studies.
• Support regulatory audits and submissions.

Skills

Leadership skills

Cleaning Validation

Excellent communication skills

Process monitoring systems knowledge

Education

Relevant technical qualification in sciences or engineering

Tools

DeltaV automation systems

Pi System

Job description

Overview

Validation Senior Engineering Specialist(s) on our Carlow Site with Technical Operations. You will be responsible for

• Leadership of validation activities within the Recovery and Cleaning qualification team and across other validation teams.
• Maintaining compliance of Global Policies, Procedures and Guidelines, regulatory requirements and execute current Good Manufacturing Practices (cGMP) in the performance of day-to-day activities and all applicable job functions, ensuring consideration of the impact on GMP and compliance and decisions made.
• Compliance via documentation completion, risk assessments, closing out corrective actions, participation in audits and inspections and proactively highlighting any issues around compliance.
• Supporting regulatory audits and submissions as required.
• Work collaboratively to drive a safe and compliant culture in Carlow.

What You Will Do

• Involvement in recovery studies, establishing and implementing acceptance criteria, cycle development, initial qualification activities for new product introductions and periodic revalidation on the Carlow site.
• Planning, scheduling and oversight of Periodic Revalidation & Initial Qualification studies.
• Responsible for setting and delivery of validation strategies.
• Lead and supports complex & critical investigations associated with validation and commercial activities.
• Co-ordinate multiple complex projects in parallel including but not limited New Product Introductions, Process Improvements and Investigations.
• Execution of Periodic Revalidation, Cycle Development & Initial Qualification studies as required.
• Technical review and approval of Periodic Revalidation, Cycle Development & Initial Qualification protocols & reports.
• Authoring and reviewing standard operating procedures and technical reports.
• Engage in the early stages of projects.
• Act as validation SME on the equipment within the area assigned.
• Serving as a key member during internal audits and external inspections/audits.
• Implementing the requirements as outlined in the site & project Validation Master Plan(s) and periodic revalidation plan.
• Supporting regulatory submissions.
• Support continuous improvement through Lean Six Sigma methodologies.
• Make problems visible and strive for continuous improvement.
• Lead and promote various organizational initiatives as needed (examples include EHS, workload forecasting, work standardisation, etc).
• Providing technical and validation oversight to process, design and project delivery teams.
• Represent the site in internal collaborations through Manufacturing Division Communities of Practice (CoP) for Validation to include imparting of best practices in Validation and investigation activities.
• Keep up to date with scientific and technical developments, best practices and attend seminars.
• Maintain continuous focus on quality and safety compliance and unflinching focus on the customer.
• Within the role you will be acting as a validation engineer reporting within the Validation Engineering Team.

What Skills You Will Need

• Proven history of leadership skills within current and previous roles.
• Relevant technical qualification(s) in Applied Pharmaceutical / Biological / Computer / Chemical sciences or applied Technical / Engineering qualification, the successful candidate will also have a proven track record in delivering excellence.
• A minimum of 4-5 years directly related experience in academia, pharmaceutical or biotechnology industry – along with a working knowledge of current regulatory requirements and current Good Manufacturing Practices.
• SME in Cleaning Validation for reusable parts and process vessel washing and using Automated COP and CIP systems.
• Knowledge of process monitoring systems, automation systems (DeltaV), operational intelligence & data systems (Pi System) within a GMP manufacturing environment would be beneficial and desirable.
• Experience of coaching, mentoring and leading a team in the validation department in the past is desirable.
• Prior experience in drug product processing equipment, PQ, Process Performance Qualification and Validation, site readiness, authoring documents subject to regulatory inspection.
• Knowledge of regulatory/code requirements to Irish, European and International Codes, Standards and Practices.
• Analysing and interpreting complex data.
• Excellent communication, presentation and interpersonal skills, to interface effectively with all levels of colleagues and with external customers in a team orientated manner.
• Experience in working in other validation areas such CTU, Isolator and Filling Lines, Sterilisation (SIP & Autoclaves), Ancillary Qualification (Filters, CCI, Shipping) is considered advantageous but not mandatory.

Job Details

• Location: Carlow, County Carlow, Ireland
• Requisition ID: R356783
• Employment type: Full-time
• Job Posting End Date: 07/30/2025

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