Job Description
Validation Senior Engineering Specialist(s) – Carlow Site, Technical Operations
Responsibilities
Leadership of validation activities within the Recovery and Cleaning qualification team and across other validation teams.
Maintain compliance with Global Policies, Procedures, Guidelines, regulatory requirements and execute current Good Manufacturing Practices (cGMP) in daily activities.
Document completion, risk assessments, corrective actions, audits and inspections, proactively highlighting any compliance issues.
Support regulatory audits and submissions as required.
Plan, schedule and oversee Periodic Revalidation & Initial Qualification studies.
Set and deliver validation strategies.
Lead and support complex & critical investigations related to validation and commercial activities.
Coordinate multiple complex projects in parallel including New Product Introductions, Process Improvements and Investigations.
Execute Periodic Revalidation, Cycle Development & Initial Qualification studies as required.
Conduct technical review and approval of validation protocols and reports.
Author and review standard operating procedures and technical reports.
Engage in the early stages of projects.
Act as validation SME on the assigned equipment.
Serve as a key member during internal audits and external inspections/audits.
Implement requirements outlined in the site & project Validation Master Plan(s) and periodic revalidation plan.
Provide technical and validation oversight to process, design and project delivery teams.
Represent the site in internal collaborations through Manufacturing Division Communities of Practice for Validation.
Maintain a continuous focus on quality and safety compliance and customer focus.
Act as a validation engineer reporting within the Validation Engineering Team.
Qualifications
Proven leadership experience in current and previous roles.
Relevant technical qualification(s) in Applied Pharmaceutical/Biological/Computer/Chemical sciences or an applied Technical/Engineering qualification with a track record of delivering excellence.
Minimum 4‑5 years of directly related experience in academia, pharmaceutical or biotechnology industry with knowledge of current regulatory requirements and Good Manufacturing Practices.
SME in Cleaning Validation for reusable parts and process vessel washing 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 is beneficial.
Experience in coaching, mentoring and leading a validation team is desirable.
Prior experience in drug product processing equipment, PQ, Process Performance Qualification and Validation, site readiness and authoring documentation subject to regulatory inspection.
Knowledge of regulatory/code requirements to Irish, European and International Codes, Standards and Practices.
Experience in other validation areas such as CTU, Isolator and Filling Lines, Sterilisation, Ancillary Qualification (Filters, CCI, Shipping) is advantageous but not mandatory.
Required Skills
Adaptability
Data Analysis
Deviation Management
Equipment Qualification
GMP Compliance
Good Manufacturing Practices (GMP)
New Product Introduction Process
Regulatory Audits
Sterile Manufacturing
Troubleshooting
Preferred Skills
Standard Operating Procedure (SOP)
Validation Activities
Employment Details
Employee Status: Regular
Relocation: No relocation
VISA Sponsorship: Yes
Travel Requirements: No Travel Required
Flexible Work Arrangements: Hybrid
Shift: Not Indicated
Valid Driving License: No
Hazardous Material(s): n/a
Equal Opportunity Employer
We are an equal opportunity employer and are proud to embrace the value of bringing diverse, talented, and committed people together.
Requisition ID
R398529
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