- Our client is excited to offer a fantastic Engineering Specialist (Validation) opportunity for candidates interested in a new challenge in a cGMP regulatory environment.
- The successful candidate will support several aspects of Validation: predominantly qualification of Controlled Temperature Units (CTU).
Core Duties and Responsibilities:
- 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 on site.
- May be required to perform other duties as assigned.
Minimum Qualifications and Experience:
- 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.
- Knowledge and experience of the below areas will be considered advantageous
- Equipment Periodic Validation
- Equipment Validation Lifecycle
- Project Management Skills/Qualification
- Filter Validation & Container Closure Validation
- Autoclave/SIP Sterilisation Validation
- Dry Heat Sterilisation
- Isolator Qualifcation
- Vial and Syringe Processing Technologies
- 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.
To Apply: Quote – PE22107
If you would like to discuss this vacancy or to discuss your career and other job opportunities in confidence, contact us:
14 Danville Business Park, Kilkenny, Ireland
+353 56 77 90100
Please note, we do not require agency assistance with this role.