1 day ago Be among the first 25 applicants
Direct message the job poster from PE Global
Senior Recruitment Consultant @ PE Global
The role:
PE Global is currently recruiting for a Validation Engineer on behalf of a leading pharmaceutical company based in Carlow. This is an initial 11-month contract role.
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 in Carlow.
* May be required to perform other duties as assigned.
Education and Experience:
* Relevant technical qualification(s) in Applied Pharmaceutical / Biological / Chemical sciences or applied Technical / Engineering qualification
* Experience in authoring, reviewing, executing and approving Isolator Airflow Visualisation/ VHP/HVAC Qualification documents.
* 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.
* Equipment and process validation.
* Sterile Fill-Finish processes and equipment.
* Proficiency in Microsoft Office and job-related computer applications
* Excellent communication, presentation, and interpersonal skills, to interface effectively with all levels of colleagues and with external customers in a team orientated manner.
Desirable but not essential;
* Filter Validation
* Shipping Qualification
* Equipment Periodic Validation
* Equipment Validation Lifecycle
* Project Management Skills/Qualification
* Cleaning Validation
* Controlled Temperature Units/Equipment Qualification
* Vial and Syringe Processing Technologies
Interested candidates should submit an updated CV.
Please click the link below to apply, call Kellie on 0214297900 or alternatively send an up to date CV to kellie.hackett@peglobal.net
***Please note our client cannot assist with any visa sponsorship and candidates must have the correct visa to live and work in Ireland***
Seniority level
* Seniority level
Mid-Senior level
Employment type
* Employment type
Contract
Job function
* Industries
Staffing and Recruiting
Referrals increase your chances of interviewing at PE Global by 2x
Get notified about new Validation Engineer jobs in Carlow, County Carlow, Ireland.
Carlow, County Carlow, Ireland 5 days ago
Carlow, County Carlow, Ireland 2 weeks ago
Carlow, County Carlow, Ireland 2 weeks ago
Carlow, County Carlow, Ireland 4 days ago
Carlow, County Carlow, Ireland 3 weeks ago
Carlow, County Carlow, Ireland 1 week ago
Carlow, County Carlow, Ireland 2 weeks ago
Carlow, County Carlow, Ireland 18 hours ago
Carlow, County Carlow, Ireland 1 week ago
Carlow, County Carlow, Ireland 21 hours ago
Carlow, County Carlow, Ireland 5 days ago
Carlow, County Carlow, Ireland 5 days ago
Carlow, County Carlow, Ireland 5 days ago
Quality Assurance Automation Tester Engineer, Officer
Carlow, County Carlow, Ireland 3 days ago
Governance Lead - Software Development & Cloud Security
We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI.
#J-18808-Ljbffr