Amgen Job Description Under general supervision, employee will perform operations in the Manufacturing area, specifically Purification processes. Operations will be performed according to Standard Operating Procedures (SOPs). Employee will perform and mo
Description
Amgen Job Description Under general supervision, employee will perform operations in the Manufacturing area, specifically Purification processes. Operations will be performed according to Standard Operating Procedures (SOPs). Employee will perform and monitor critical processes, execute routine validation protocols, and regularly draft and revise documents such as Manufacturing Procedures, SOPs, and technical reports. Employee will also perform basic troubleshooting and assist in the review of documentation for assigned functions. May participate on cross-functional teams and represent the Purification group. Employee may also have the responsibility of owning NC/CAPA's and Change Control records. In addition, employee may identify, recommend, and implement improvements related to routine functions.
Shift Schedule: B shift, 7:00am - 7:00pm
Basic Qualifications • Bachelor's degree OR receiving Bachelor's degree by June 2015
OR
• Associate's degree & 4 years of Manufacturing & Operations experience
OR
• High School diploma/GED & 6 years of Manufacturing & Operations experience.
Preferred Qualifications • Knowledge of large scale Purification operations, chromatography, TFF, aseptic processing, etc
• CFR and Regulatory knowledge
• Mechanical ability/expertise
• Knowledge of WIP lab equipment and computers, with LIMS access
• Basic statistical mathematical skills
• Ability to interpret and apply GMP knowledge
• Understanding of analytical methods for manufacturing area
• Ability to demonstrate technical writing capability with Trackwise access
• Able to demonstrate project management skills and presentation skills
• Independently collaborate with outside resources
• Ability to understand, apply and evaluate basic chemistry, biology and physical principles
• Basic troubleshooting skills on Purification equipment
• Experience with Delta V, RD's
• Experience with lab equipment/testing
Nr of positions available : 1
Research Fields
Other
Other
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 - RI - West Greenwich