Amgen Job Description This engineering position supports commissioning and qualification activities associated with cGMP equipment acquisition and facility modification at Amgen Thousand Oaks (ATO). The C&Q engineer will lead verification activities in a

Description

Amgen Job Description This engineering position supports commissioning and qualification activities associated with cGMP equipment acquisition and facility modification at Amgen Thousand Oaks (ATO). The C&Q engineer will lead verification activities in alignment with Amgen's Commissioning and Qualification Process (CQP) to ensure that new GMP equipment is installed and maintained in a validated state. The C&Q engineer works in partnership with the Project Manager, Engineering Technical Lead, and Equipment System Owners to develop and oversee the commissioning strategy for new equipment. Finally, the C&Q engineer must work closely with Quality Assurance (QA) throughout the commissioning process and obtain QA approval of the commissioning strategy and commissioning summary report.


In addition to supporting the commissioning and qualification of new equipment, the C&Q engineer will support periodic review of manufacturing systems to ensure that they remain in a validated state. 


The C&Q engineer will support the Drug Product New Product Introduction (NPI) team in defining strategies for preclinical quality systems verification of combination products. The C&Q engineer will work with the NPI team to develop and document phase appropriate practices for device characterization, human factors evaluation, and formative studies that are integrated into Amgen's Commissioning & Qualification Process. 


The C&Q Engineer role will provide direct engineering technical support as follows:


• Be individually accountable for the verification deliverables on key capital projects 


• Assist in the identification of critical quality parameters and process attributes for new equipment or facility modifications.


• Assist in development and review of User Requirements Specifications (URS).


• Facilitate formal quality risk assessments (Quality Risk Assessment for Automation and Equipment Systems) - QRAES


• Suggest design modifications to address risks and design in quality and safety.


• Develop the commissioning strategy based on the URS and QRAES to validate equipment design while minimizing project cost and schedule impact (risk-based approach).


• Oversee development of validation protocols in line with CQP, Automation Systems Delivery SOPs, and cGMP standards.


• Recommend, evaluate, and manage performance of contract commissioning agent resources


• Provide oversight for verification deliverables developed by outsourced/contract verification staff.


• Act as a liaison between Engineering and Quality Assurance during project planning, execution, and closeout


• Ensure that validation protocols are executed and documented in accordance with cGMP good documentation practices.


• Ensure safety during commissioning and validation activities


• Review and approve the Commissioning Summary Report and ensure that all verification exceptions...

Nr of positions available : 1

Research Fields

Physics 
Engineering

Career Stage

Early stage researcher or 0-4 yrs (Post graduate) 
Experienced researcher or 4-10 yrs (Post-Doc) 
More Experienced researcher or >10 yrs (Senior) 

Research Profiles

Not defined

Comment/web site for additional job details

US - CA - Thousand Oaks