Arcadis DPS group are recruiting a Senior Validation Engineer (Sterilization / Temp Mapping) for a Biopharmaceutical assignment in Carlow
Responsibilities will include management & delivery of the below key activities:
* Providing technical support as needed and supporting CC, QN, CAPA Creation & Closures
* Reporting progress to Project Managers; Site Stakeholders, DPS counterparts etc.
* Dealing with various escalated issues, as they arise
* Ensuring delivery of Temperature Mapping / Sterilisation scope
* Draft and get protocols pre-approved
* Execute as per the PRV Plan for Autoclaves and SIP Qualification
* Execute approved Autoclave and SIP Projects
* Close out executed packs with support from SMEs (Document/Pack Owners)
* Draft and get reports approved
* Draft and get exceptions and deviations approved
* Support Maintenance & Summer shutdown activities with STP
* Participate with any RCAs
* Assitsting with training of new starters
* Complete "My Learning" requirements on time
* Create and complete periodic reviews of applicable SOPs and WIs
* Schedule execution activities
* Confirm material requirements for Autoclave and SIP Qualification Studies
* Request required support from IPT, QA, Micro, Automation and Maintenance
* Continuous Improvements relating to LIVES System, Execution of SIP/Autoclaves, Right First Time
* Support Audit
* Escalate execution issues as needed
* Ensuring compliance with GMP and all relevant policies and procedures
* Additional Duties as required
Desired Skills and Experience:
* Degree level qualification, science or engineering discipline preferred
* Familiarity with regulatory standards relevant to the Pharmaceutical Industry
* 6+ years of experience working in Validation / Quality roles.
* Knowledge of Sterilisation Validation for the Pharmaceutical / Med Device Industry
* Excellent communication & presentation skills – both written & verbal
* Proven lead skills in a busy and changing working environment
* Ability to chair and lead discussions
* Excellent interpersonal, organisational and multitasking skills
* Dynamic ability to work across a portfolio of projects
* Strong attention to detail and reporting skills. Strong problem-solving skills
* Self-starter capable of working on own with minimal supervision
Interested parties should apply via the link below or contact Fergal Walshe at DPS Engineering (via LinkedIn) for more information on the role
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