Job Specification - Validation Engineer II - Contract

HERO Recruitment are pleased to present several Validation opportunities for individuals seeking a new challenge in a cGMP regulatory environment. The roles will have a WFH element. The successful candidates will play a crucial role in supporting various aspects of Validation. The available positions require experienced, dynamic, and dedicated engineers in the following areas:

• Sterilization (Autoclaves, SIP of vessels)
• Cleaning (Parts Washer and CIP of vessels)
• Isolator (Filling, Sterility & Material Transfer isolators) - HVAC, VHP, E-Beam, and Depyrogenation systems
• Controlled Temperature Units (CTU) – Temperature/Humidity Mapping
• Filter Validation

Key Responsibilities

Validation Documentation: Design, author, review, approve, and execute qualification/validation documentation, adhering to standard approval processes.

Change Control: Lead and participate in the execution and development of change controls, ensuring efficient resolution of technical issues during study execution.

Cross-Functional Collaboration: Engage with Production, Maintenance, and Quality representatives during Cycle Development & Performance Qualification activities in assigned areas.

Root Cause Analysis: Conduct root cause analysis of system failures and substandard performance, utilizing standard tools and methods to resolve machine and system issues.

Experience, Knowledge & Skills

Relevant Qualifications: Possess technical qualifications in Applied Pharmaceutical/Biological/Chemical sciences or applied Technical/Engineering fields, coupled with a proven track record of delivering excellence.

Experience: Minimum of at least 1 - 2 years of Validation experience is required. Pharmaceutical experience is a bonus. 

CTU and Mapping: Knowledge of CTU equipment qualification and thermal mapping equipment, with demonstrated thermal mapping skills.

Project Management: Proven experience in leading technical-related projects within a GMP manufacturing environment.

Regulatory Compliance: Familiarity with regulatory/code requirements related to Irish, European, and International Codes, Standards, and Practices.

If you are interested in this opportunity and meet the requirements, please contact Eoghan Colton on 086 839 5533 or stem@hero.ie

Check out all our open jobs on our HERO Recruitment website – https://www.hero.ie/ 

Please Note: Under its obligation under the Data Protection legislation, HERO Recruitment will not forward your details to any company without your prior approval

Data can only be transferred outside of the EEA on the basis of standards contractual clauses, to a country for whom an adequacy decision has been given by the European Commission or where the express permission of the data subject has been given.  You have supplied us with your personal data in the process of applying for a position.  Our client company may have personnel outside of the EEA who will review you data.  We will apply the appropriate criteria in respect of the data transfer depending on the location of those personnel.