Pharma Validation Engineer Ireland

PSC Biotech Corporation; São Paulo; Presencial; BRL 60.000 - 100.000; Tempo integral

Resumo da oferta

An established industry player is seeking a Senior Recruiter for an exciting Engineering Specialist role in Validation. This position offers a unique opportunity to work in a cGMP regulatory environment, focusing on critical areas such as sterilization, cleaning, and controlled temperature units. The successful candidate will engage with various teams to ensure compliance and drive continuous improvement through Lean Six Sigma methodologies. If you have a strong technical background and a passion for excellence, this role is perfect for you. Join a dynamic team and contribute to impactful projects in the biotechnology and pharmaceutical manufacturing sectors.

Qualificações

• Proven track record in delivering excellence in validation.
• Knowledge of CTU equipment qualification and thermal mapping equipment.

Responsabilidades

• Design and execute qualification/validation documentation.
• Resolve technical issues during study execution.
• Engage with cross-functional teams for compliance.

Conhecimentos

Thermal mapping skills

Project Management Skills

Communication skills

Root cause analysis

Lean Six Sigma methodologies

Deviation Management

Equipment and process validation

Data analysis and interpretation

Formação académica

Technical qualification in Applied Pharmaceutical/Biological/Chemical sciences

Applied Technical/Engineering qualification

Ferramentas

Microsoft Office

DeltaV

Pi System

Descrição da oferta de emprego

Senior Recruiter at PSC Biotech Corporation

Role Description:

Our site is 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:

• 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:

• 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.
• Demonstrable 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.
• 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 oriented manner.
• Equipment Periodic Validation.
• Equipment Validation Lifecycle.
• Project Management Skills/Qualification.
• Filter Validation & Container Closure Validation.
• 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.

Seniority level

• Mid-Senior level

Employment type

• Full-time

Job function

• Engineering, Manufacturing, and Quality Assurance
• Industries
• Biotechnology Research and Pharmaceutical Manufacturing