Dieses Jobangebot ist archiviert und steht nicht mehr zur Verfügung.
Vakante Jobangebote finden Sie unter Projekte.
Vakante Jobangebote finden Sie unter Projekte.
Validation Engineer
Eingestellt von Quanta Consultancy Services
Gesuchte Skills: Engineer, Support
Projektbeschreibung
Role - Validation Engineer
Location - Dublin
Type - initially 6 month contract
One of our key Pharmaceutical clients is looking for an experienced, hands-on' Validation Engineer.
Key Responsibilities:
Participate in design of systems and equipment, initiate and implement change control activities, coordinate validation activities with other departments
Provide guidance on regulatory requirements and associated systems.
Ensure systems and equipment maintain validated status.
Provide guidance and leadership to the validation team.
Manage the product and process life cycle
Support internal teams with delivery on schedules
Ensure compliance with Quality & EHS requirements
Identify, lead and implement continuous improvement opportunities
System/Sub System Owner or SME for Quality Management System (eg: Change Control)
Use scientific data based problem solving, process development and validation.
Act as SME for appropriate processes or technologies.
Development and approval of trial protocols, hypothesis testing, validation protocols and the execution of validation testing
Monitor progress of trials, testing and validation, and the review and approval of validation protocols and reports within the required time schedule.
Manage the technology transfer of manufacturing processes.
Key Requirements:
Strong previous background in process/equipment/cleaning/facility/packaging validation within the Pharmaceutical industry
Knowledge of manufacturing sterile and solid oral dosage forms
Demonstrated capability to lead a Departmental Project team between 1 and 10 people.
The successful candidate will have project management experience and equipment qualification experience.
GMP and EHS Regulations and guidelines.
Experience with file submissions to the regulatory authorities (EMEA/FDA), audit preparations
Location - Dublin
Type - initially 6 month contract
One of our key Pharmaceutical clients is looking for an experienced, hands-on' Validation Engineer.
Key Responsibilities:
Participate in design of systems and equipment, initiate and implement change control activities, coordinate validation activities with other departments
Provide guidance on regulatory requirements and associated systems.
Ensure systems and equipment maintain validated status.
Provide guidance and leadership to the validation team.
Manage the product and process life cycle
Support internal teams with delivery on schedules
Ensure compliance with Quality & EHS requirements
Identify, lead and implement continuous improvement opportunities
System/Sub System Owner or SME for Quality Management System (eg: Change Control)
Use scientific data based problem solving, process development and validation.
Act as SME for appropriate processes or technologies.
Development and approval of trial protocols, hypothesis testing, validation protocols and the execution of validation testing
Monitor progress of trials, testing and validation, and the review and approval of validation protocols and reports within the required time schedule.
Manage the technology transfer of manufacturing processes.
Key Requirements:
Strong previous background in process/equipment/cleaning/facility/packaging validation within the Pharmaceutical industry
Knowledge of manufacturing sterile and solid oral dosage forms
Demonstrated capability to lead a Departmental Project team between 1 and 10 people.
The successful candidate will have project management experience and equipment qualification experience.
GMP and EHS Regulations and guidelines.
Experience with file submissions to the regulatory authorities (EMEA/FDA), audit preparations
Projektdetails
Geforderte Qualifikationen
-
Kategorie:
Ingenieurwesen/Technik, Sonstiges