Senior validation specialist


Premium Job From Real Staffing

Recruiter

Real Staffing

Listed on

30th June 2020

Location

Cork

Salary/Rate

£36 - £54

Type

Contract

This job has now expired please search on the home page to find live IT Jobs.

This position will provide expert technical support to the Vaccines IPT for the Qualification, Validation and Technical activities for Vaccines IPT manufacture.

The Validation/Technical Specialist will be required to lead and collaborate across functional teams on site on the qualification/requalification of utilities and equipment.

POSITION RESPONSIBILITIESEnsure highest Quality, Compliance and Safety standards are adhered to.Validation protocol/report authoring/execution/oversight/approval as appropriate.Recommend and approve technical approaches in line with global and local standards.Maximize team member performance through continuous process improvement initiatives, coaching, and providing guidance to team members.Benchmark and remain current with development of new technologies in the vaccine and biopharmaceutical processing field of expertise and seek to deploy process improvements through innovation and utilization of these technological advances.Participate in problem solving teams across all areas of the Vaccine IPTLead process related deviations and reports. QUALIFICATIONS & EXPERIENCE - KNOWLEDGE AND SKILLS REQUIREMENTS

GeneralMinimum 6 years' experience in a regulated manufacturing environment.Demonstrated knowledge in validation and other pharmaceutical or Biopharmaceutical operations (e.g. manufacturing, technology, engineering, quality, analytical).Demonstrated leadership and delivery of technical/validation projects.TechnicalKnowledge of cleaning validation and CIP systems, development of associated strategies and execution of activities.Knowledge of temperature mapping activities, requalification requirements of equipment, periodic reviews of equipment, autoclave and SIP requirements.Knowledge of the requirements around sanitization and sterilization processes.Understanding of Computer Systems Validation.Good working knowledge of Data Integrity RequirementsDemonstrated qualification and validation SME background within the pharmaceutical or Biopharmaceutical industry.Demonstrated capability to deliver results RFT, in an FDA / HPRA Regulated production environment.Demonstrated high level of problem solving and facilitation skills.Working and collaboration across multiple functional teams.Change management skills. Please click here to find out more about our Key Information Documents. Please note that the documents provided contain generic information. If we are successful in finding you an assignment, you will receive a Key Information Document which will be specific to the vendor set-up you have chosen and your placement.To find out more about Real please visit www.realstaffing.comReal Staffing, a trading division of SThree Partnership LLP is acting as an Employment Business in relation to this vacancy| Registered office | 1st Floor, 75 King William Street, London, EC4N 7BE, United Kingdom | Partnership Number | OC387148 England and Wales

You are currently using an outdated browser.

Please consider using a modern browser such as one listed below: