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PDP | Talent Acquisition Specialist | Life Science Engineering | CQV & Project Controls
JOB SUMMARY
PDP 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
* Container Closure Integrity Validation
MAIN RESPONSIBILITIES
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 Carlow.
* May be required to perform other duties as assigned.
REQUIRED EXPERIENCE/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.
* 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
* 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
* Relevant Degree level, 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
* Seniority level
Mid-Senior level
Employment type
* Employment type
Contract
Job function
* Industries
Engineering Services and Pharmaceutical Manufacturing
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