Validation Engineer

3 weeks ago

Waterford, Waterford, Ireland eir evo talent Full time

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Senior Recruitment Consultant at eirevo talent

Validation Engineer

Type :12 month contract

Location:Waterford

Work Model : Fully Onsite

The Role

In the Validation Engineer role, you will be required to support a new project

The Validation Engineer has a key role in ensuring the on-going validation and compliance of new equipment, systems and processes at Sanofi Ireland.

Job Responsibilities:

Executing FAT/SAT/IOQ protocols including generation of protocols and reports.
Designing, executing and reporting on validation studies for equipment, systems and processes.
Ensuring validation studies are managed in conjunction with all required Sanofi standards and legal requirements (Health & Safety, cGMP, construction, environmental etc.)
Providing technical interpretation and guidance of current US FDA and EU validation requirements for aseptic processing, lyophilisation, sterilisation and depyrogenation
Ensuring that the validation status of equipment and systems are in compliance with cGMP at all times
Maintaining validation documentation through the validation lifecycle
Participation in external regulatory inspections
Support Site Change Control process

Skills :

Experience: 3-5 years' experience working in a Healthcare manufacturing environment – ideally part of which would be in the pharmaceutical sector.
Capable of troubleshooting validation issues associated with projects, process development etc.
Competent technical knowledge of pharmaceutical plants.
Previous validation/product development experience would be highly advantageous for the role.
Knowledge of Process Validation regulations, current process validation and technical transfer industry practices, and experience of interpretation and application of guidelines and regulations.
Knowledge of requirements for of GAMP, ISPE Baseline guides.
Knowledge of steam and dry heat validation publications such as AAMI/ANSI, PDA and ISO guidelines.
Full understanding of relevant quality and compliance regulations
Able to execute projects to plan.
Good knowledge of quality management systems.
Good communication skills at organisation, team and individual levels.
Ability to use MS Project and SPC packages an advantage
Understands KPI's for the site.
Previous Equipment knowledge for example pack lines, Autoclaves, Isolator Technology and fill lines would be an advantage.

If you would like to discuss this role in confidence, contact Harleen Tora/harleen.tora@eirevo.ie

Candidates must be eligible to work full time and long term in the location specified or currently hold a valid appropriate long term work Visa to apply.

eir evo talent, eir evo and our clients are equal opportunity employers who seeks to recruit and appoint the best available person for a job regardless of marital / civil partnership status, sex (including pregnancy), age, religion, belief, race, nationality and ethnic or national origin, colour, sexual orientation or disability. eir evo talent, eir evo and our clients apply all relevant Data Protection laws when processing your Personal Data.

If you choose to apply to this opportunity and share your CV or other personal information with eir evo talent, eir evo and our clients, these details will be held by us in accordance with our privacy policy used by our recruitment team to contact you regarding this or other relevant opportunities at eir evo talent and eir evo

Seniority level

Seniority levelMid-Senior level

Employment type

Employment typeContract

Job function

Job functionHealth Care Provider
IndustriesPharmaceutical Manufacturing

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