Validation Engineer

Sectors:
Aerospace, shipbuilding, other transport equipment, Automotive, Electrical, optical, Engineering
Locations:
International
Qualifications:
Not specified
Contract type:
Permanent
Hours:
Full time
Salary description:
Competitive
Sub-sectors:
All
Specialist areas:
Quality assurance (main), Audit/assessment, Consultancy, Health and safety, Operational improvement, Project management, Risk management
Posted:
19/10/2020
Start Date:
ASAP
Recruiter:
Agilent
Job Ref:
964334226

Agilent inspires and supports discoveries that advance the quality of life. We provide life science, diagnostic and applied market laboratories worldwide with instruments, services, consumables, applications and expertise. Agilent enables customers to gain the answers and insights they seek -- so they can do what they do best: improve the world around us. Information about Agilent is available at .

The world's most revolutionary biopharma companies are partnering with Agilent Technologies to advance the next frontier of medicine. Agilent continues to invest in the capacity and expansion of its Colorado operations. Join our team of professionals dedicated to the development and commercialization of nucleic acid therapeutics for life-changing, life-saving medicines.

The Validation Engineer is responsible for the execution of validation activities at the Active Pharmaceutical Ingredient (API) manufacturing site of Agilent Technologies Nucleic Acid Solutions Division. Generating and executing validation study documentation including protocols, requirements specifications, new equipment acceptance forms, commissioning documentation, final reports and addenda while ensuring compliance with cGMP requirements. Execute validation studies in support of engineering, manufacturing, process development, facilities, information technology, quality control, and quality assurance.

ESSENTIAL DUTIES AND RESPONSIBILITIES
* Generates, revises, and executes documentation for validation studies ensuring compliance with QA and cGMP systems. Responsible for generating and executing validation protocols for equipment, instruments, utilities, and control systems through commissioning, URS, Software Acceptance Testing (SAT) IQ, OQ, and PQ phases.
* Responsible for temperature mapping of facility Controlled Temperature Units, Stability Chambers, Warehouse Space, Autoclave, Incubators, Humidity Controlled Rooms/Glove boxes and Cold Rooms. Involves the startup of new Controlled Temperature Units.
* Assist with contractor audits, supplier audits, pre-delivery inspections and on-site factory acceptance tests when related to validation. This may involve short periods of travel.
* Responsible for the calibration of equipment supporting validation protocols and ensuring the calibration specifications for the equipment are appropriate.
* Responsible to participate in both factory and site acceptance testing for new manufacturing and engineering equipment.
* Required to support the validation schedule within the scope of ongoing projects.
* Generate and oversee facility qualification of classified environments.
* Support manufacturing, engineering, quality assurance, and quality control for validation related activities.
* Provide the generation and execution of cleaning validation support activities, such as: spray ball coverage testing, equipment characterization reports, protocol generation and review, and equipment sampling SOPs.
* Assist with validation planning and risk assessments associated with validation activities.
* Resolve CAPA's, nonconformances, protocol incidents, and change controls related to validation protocols.
* Execute lyophilizer, HVAC, and autoclave annual requalification and final package integrity testing.
* Generate data and reports for the validation system evaluation program.

Closing Date:
16/11/2020
Contact Details:
Agilent
Contact: N/A

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