Job Overview
A new and exciting opportunity has come for a Validation Senior Engineering Specialist on our Carlow Site with Technical Operations.
The successful candidate will be responsible for leadership of validation activities within the Recovery and Cleaning qualification team and across other validation teams.
They will maintain compliance with global policies, procedures, guidelines, regulatory requirements, and execute current Good Manufacturing Practices (cGMP) in day-to-day activities, ensuring consideration of the impact on GMP and compliance decisions.
Responsibilities include documentation completion, risk assessments, closing out corrective actions, participation in audits and inspections, and proactively highlighting any compliance issues.
Supporting regulatory audits and submissions is also required.
What You Will Do
Planning, scheduling and oversight of Periodic Revalidation & Initial Qualification studies.
Responsible for setting and delivery of validation strategies.
Lead and support complex & critical investigations associated with validation and commercial activities.
Coordinate multiple complex projects in parallel, including but not limited to New Product Introductions, Process Improvements, and Investigations.
Execute Periodic Revalidation, Cycle Development & Initial Qualification studies as required.
Provide technical review and approval of protocols & reports.
Author and review standard operating procedures and technical reports.
Engage in the early stages of projects.
Act as validation SME on the equipment within the assigned area.
Serve as a key member during internal audits and external inspections/audits.
Implement requirements as outlined in the site & project Validation Master Plan(s) and periodic revalidation plan.
Support regulatory submissions.
Lead and promote various organizational initiatives as needed (e.g., EHS, workload forecasting, work standardisation).
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 to impart best practices.
Maintain continuous focus on quality and safety compliance.
Qualifications
Proven history of leadership skills within current and previous roles.
Relevant technical qualification(s) in Applied Pharmaceutical / Biological / Computer / Chemical sciences or an applied Technical / Engineering qualification.
A minimum of 4-5 years directly related experience in academia, pharmaceutical or biotechnology industry, with a working knowledge of current regulatory requirements and current 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.
Experience in coaching, mentoring and leading a team in the validation department.
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.
Experience in other validation areas such as CTU, Isolator and Filling Lines, Sterilisation (SIP & Autoclaves), Ancillary Qualification (Filters, CCI, Shipping) is considered 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
Equal Opportunity Statement
As an equal opportunity employer, we are proud to be a company that embraces the value of bringing diverse, talented, and committed people together.
We keep the patient at the very heart of all that we do and strive to find solutions and treatments for some of the world's most challenging healthcare needs.
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