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CQV Engineer- Process Equipment
Eingestellt von Quanta Consultancy Services
Gesuchte Skills: Engineer, Support
Projektbeschreibung
A CQV Engineer is required by a leading biotechnology company to work on its new filling line in Ireland.
The CQV Engineer performs activities to support the commissioning and qualification activities in our client's cGMP fill finish manufacturing plant in Ireland and subsequent validation activities. The role is a 6 month contract position as part of the CQV team.
The role will include fit checking, commissioning equipment and shakedown of new parts and qualifying the process equipment on the new line.
KEY RESPONSIBILITIES
- CQV documentation - drafting, reviewing and approving CQV documentation.
- To co-ordinate and execute Facility, Utilities, HVAC, equipment and Controlled Temperature Units commissioning, qualification and validation programs where applicable.
- Accountable for scheduling, tracking, reporting and achieving project deadlines
- Input into the core aspects of Operations, Qualification and Validation SOP's.
- Actively contribute to project teams.
- Performing data analysis and determine conclusions reached.
Make informed decisions/recommendations around conclusions reached from data analysis.
- A good concept and understanding of Microbiological terminology and principles.
Reviewing and approval of data analysis and reporting.
- Attends departmental and team meetings focused on CQV activities.
- Serve as a CQV representative for internal technical group discussions.
EXPERIENCE REQUIRED:
- Qualification experience of autoclaves, parts washers, semi-automatic inspection machines, compounding vessels, filter integrity testers, CIP skids
The CQV Engineer performs activities to support the commissioning and qualification activities in our client's cGMP fill finish manufacturing plant in Ireland and subsequent validation activities. The role is a 6 month contract position as part of the CQV team.
The role will include fit checking, commissioning equipment and shakedown of new parts and qualifying the process equipment on the new line.
KEY RESPONSIBILITIES
- CQV documentation - drafting, reviewing and approving CQV documentation.
- To co-ordinate and execute Facility, Utilities, HVAC, equipment and Controlled Temperature Units commissioning, qualification and validation programs where applicable.
- Accountable for scheduling, tracking, reporting and achieving project deadlines
- Input into the core aspects of Operations, Qualification and Validation SOP's.
- Actively contribute to project teams.
- Performing data analysis and determine conclusions reached.
Make informed decisions/recommendations around conclusions reached from data analysis.
- A good concept and understanding of Microbiological terminology and principles.
Reviewing and approval of data analysis and reporting.
- Attends departmental and team meetings focused on CQV activities.
- Serve as a CQV representative for internal technical group discussions.
EXPERIENCE REQUIRED:
- Qualification experience of autoclaves, parts washers, semi-automatic inspection machines, compounding vessels, filter integrity testers, CIP skids
Projektdetails
Geforderte Qualifikationen
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Kategorie:
Ingenieurwesen/Technik, Sonstiges