Cleaning Validation SME at DPS Group
Carlow, County Carlow, Ireland -
Full Time


Start Date

Immediate

Expiry Date

24 Aug, 25

Salary

0.0

Posted On

25 May, 25

Experience

6 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

No

Skills

Good communication skills

Industry

Information Technology/IT

Description

Arcadis DPS group are recruiting a Senior Cleaning Validation Engineer 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 rol

Responsibilities

Please refer the Job description for details

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