Validation Engineer Ireland

6 meses atrás

Sao Paulo Metropolitan Area, Brasil PSC Biotech Corporation Tempo inteiro

Role Description:

Our site are excited to offer a fantastic Engineering Specialist (Validation) opportunity for candidates interested in a new challenge in a cGMP regulatory environment. The successful candidates will support several aspects of Validation. The roles available that will require experienced, energetic and committed engineers are in the following areas:

  • Sterilisation – 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


Requirements

Role Functions:

Bring energy, knowledge, innovation to carry out the following:

  • Design/Author/Review/Approve/Execute qualification/validation documentation and cycle development studies in line with the standard approval process.
  • Design/Author/Review/Approve/Execute Execution/development of change controls.
  • Resolving technical issues encountered during study execution.
  • Engagement with Production, Maintenance and Quality representatives in the assigned area of operations during execution of Cycle Development & Performance Qualification activities.
  • Technical input into quality notification by authoring/reviewing/approving investigations.
  • Perform root cause analysis of system failures, substandard performance, using standard tools and methods, to resolve machine and system issues.
  • Support continuous improvement through Lean Six Sigma methodologies.
  • Serve as validation representative for cross functional projects and represent the validation team at global technical forums
  • Drive compliance of Global Policies, Procedures and Guidelines, regulatory requirements and execute current Good manufacturing Practices (cGMP) in the performance of day-to-day activities and all applicable job functions, ensuring consideration of the impact on GMP and compliance and decisions made.
  • Accountable for compliance via documentation completion, risk assessments, closing out corrective actions, participation in audits and inspections and proactively highlighting any issues around compliance
  • Supporting regulatory audits and submissions as required.
  • Work collaboratively to drive a safe and compliant culture in site.
  • May be required to perform other duties as assigned.

Experience,Knowledge & Skills:

In order to excel in this role, you will more than likely have considerable experience in a comparable role, with experience operating as individual contributor adding value to the business in a GMP manufacturing setting, as well as the following qualifications/skills:

  • Relevant technical qualification(s) in Applied Pharmaceutical / Biological / Chemical sciences or applied Technical / Engineering qualification, the successful candidate will also have a proven track record in delivering excellence.
  • Knowledge of CTU equipment qualification
  • Knowledge of thermal mapping equipment
  • Thermal mapping skills
  • Exception / Deviation Management and Change Control.
  • Demonstratable experience of leading technical related projects.
  • Knowledge of process monitoring systems, automation systems (DeltaV), operational intelligence & data systems (Pi System) within a GMP manufacturing environment would be beneficial and desirable
  • Evidence of continuous professional development is desirable.
  • Knowledge of regulatory/code requirements to Irish, European and International Codes, Standards and Practices.
  • Ability to analyse and interpret complex data, and link to equipment performance and out of specification findings as appropriate.
  • Report, standards, policy writing skills required.
  • Equipment and process validation.
  • Sterile Fill-Finish processes and equipment.
  • Proficiency in Microsoft Office and job-related computer applications required
  • Excellent communication, presentation and interpersonal skills, to interface effectively with all levels of colleagues and with external customers in a team orientated manner.
  • Equipment Periodic Validation
  • Equipment Validation Lifecycle
  • Project Management Skills/Qualification
  • Filter Validation & Container Closure Validation
  • Autoclave/SIP Sterilisation Validation
  • Dry Heat Sterilisation
  • Isolator Qualification
  • Vial and Syringe Processing Technologies Temperature Mapping
  • Cleaning Validation


The successful candidate will be required to work both independently and in a cross-functional team to accomplish validation project objectives. Works with moderate work direction and is skilled and knowledgeable to the position.


Qualifications & Education:

Relevant technical qualification(s) in Applied Pharmaceutical / Biological / Chemical sciences or applied Technical / Engineering qualification, the successful candidate will also have a proven track record in delivering excellence.

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