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VALIDATION LEAD
Company:RFT GROUP |
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Job Reference Number |
14602269 |
Client ID: |
RI/RFT104830JF |
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Posted On: |
Jun 8 2012 |
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Location: |
KILDARE, DUBLIN |
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Job Type: |
Permanent |
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Salary: |
NEG |
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Benefits: |
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Our Client a blue chip multinational Biopharmaceutical company based in Leinster requires an experienced Senior Validation Engineer.
You will be required to lead, implement and report on process/cleaning validation projects. To lead equipment/ Controlled Temperature Units (CTU's) qualification studies. To provide support to all other validation activities. Assert a high level of technical expertise across a range of different equipment/processes/products qualification/validation.
Responsibilities:
Validation documentation – drafting, reviewing and approving validation documentation.
To lead the execution of equipment/CTU qualification, Container Closure Integrity (CCI) and Filter validation programs
To lead cleaning validation and process validation programs
Accountable for scheduling, tracking, reporting and achieving project deadlines
To lead cycle development of equipment sterilisation/ depyrogenation/ cleaning cycles.
Input into the core aspects of Manufacturing and Cleaning SOP's.
Participation in the development of continuous improvement programs
Actively contribute to project teams.
Lead and co-ordinate the execution of the re-qualification program.
Mentoring junior validation engineers.
Conducting and participating in Risk assessments.
Assist in ensuring that any compliance/training issues both internal and site wide, are critically evaluated and highlighted as appropriate.
Information gathering and data analysis
Performing data analysis and determining conclusions reached.
Make informed decisions / recommendations around conclusions reached from data analysis.
Signing off and approving protocols, reports, change controls and process deviations.
Compliance
Understanding and applying industry specific compliance standards/regulations to all Qualification/Validation activities.
Participates in internal and external audits and inspections.
Education:
B.Sc. /B.A. degree required (science, engineering or other technical field preferred)
Experience in IMB/FDA environment advantageous.
Strong technical writing and communication skills
Ability to close items to completion.
Ability to pay high level of detail and QA data to very high standard
Ability to develop high technical aptitude in products/processes
Demonstrated leadership, interpersonal, technical aptitude, and problem solving skills.
Strong team skills, including ability to co-ordinate various departments to support validation programs.
Project Management skills.
Must be flexible and able to manage multiple priorities.
Must be goal-oriented and able to prioritize and manage risks.
Must have experience in sterile/vaccine operations.
For further details please contact John at the RFT Group on ++ 353 (0)1 2302400 or email: [email protected]
No CV or details will be submitted to any potential client without prior knowledge, discussion and consent from "every" candidate.
The RFT Group: Biopharmaceutical Division specialise exclusively in the recruitment of scientists, engineers and executives for the biotechnology, pharmaceutical and medical device sectors. For a list of all our current vacancies, view our website www.rftgroup.ie & www.medevicejobs.ie
