Pharma Validation Engineer in Ireland

Senior Recruiter at PSC Biotech Corporation

Role Description:

We are excited to offer an Engineering Specialist (Validation) opportunity in a cGMP regulatory environment. The successful candidate will support several aspects of Validation in the areas below:

• 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

Responsibilities / 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.
• Resolve technical issues encountered during study execution.
• Engage with Production, Maintenance and Quality representatives in the assigned area of operations during execution of Cycle Development & Performance Qualification activities.
• Provide technical input into quality investigations by authoring/reviewing/approving investigations.
• Perform root cause analysis of system failures or substandard performance 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 with Global Policies, Procedures and Guidelines, regulatory requirements and current Good Manufacturing Practices (cGMP) in day-to-day activities and all applicable job functions, considering impact on GMP and compliance decisions.
• Ensure compliance through documentation, risk assessments, closure of corrective actions, audits and inspections, and proactively highlighting compliance issues.
• Support regulatory audits and submissions as required.
• Work collaboratively to foster a safe and compliant culture on site.
• May be required to perform other duties as assigned.

Experience, Knowledge & Skills:

• Technical qualification(s) in Applied Pharmaceutical / Biological / Chemical sciences or engineering, with a proven track record in GMP manufacturing.
• Knowledge of CTU equipment qualification and thermal mapping equipment; thermal mapping skills.
• Exception/Deviation Management and Change Control.
• Experience leading technically related projects.
• Knowledge of process monitoring systems, automation systems (DeltaV), and data systems (Pi System) within GMP environments is beneficial.
• Evidence of continuous professional development is desirable.
• Knowledge of Irish, European and International regulatory/code requirements and standards.
• Ability to analyze and interpret complex data and relate it to equipment performance and out-of-spec findings.
• Equipment and process validation; Sterile Fill-Finish processes and equipment; Cleaning validation; Isolator qualification; Filter validation & container closure validation.
• Proficiency in Microsoft Office and job-related computer applications.
• Excellent communication, presentation and interpersonal skills to interface with colleagues and external customers.
• Equipment Periodic Validation and Equipment Validation Lifecycle knowledge.
• Project Management skills related to qualification.

Qualifications & Education:

Relevant technical qualification(s) in Applied Pharmaceutical / Biological / Chemical sciences or engineering, with a proven track record in delivering excellence.

• Mid-Senior level

• Full-time

• Engineering, Manufacturing, and Quality Assurance

• Biotechnology Research and Pharmaceutical Manufacturing