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Arcadis DPS : Life Science Engineering Experts!
Arcadis are seeking a Validation Engineer (Sterilization /Temp Mapping) for a managed service team onsite at a Biopharma facility on a long term contracting basis.
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 scope by the team
* 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
* Training of new starters
* Complete My Learning 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
* 4+ years of experience working in Validation / Quality roles.
* Knowledge of Sterilisation Validation for the Pharmaceutical / Med Device Industry
* Experience of leading teams in the pharmaceutical industry
* Proven lead skills in a busy and changing working environment
* Ability to chair and lead discussions
* Excellent interpersonal, organizational and multitasking skills
* Dynamic ability to work across a portfolio of projects
* Proven ability to manage people & teams
* 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 for more information on the opportunity
Seniority level
* Seniority level
Not Applicable
Employment type
* Employment type
Contract
Job function
* Job function
Engineering, Science, and Project Management
* Industries
Engineering Services, Biotechnology Research, and Pharmaceutical Manufacturing
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