View all jobs

Sr Engineer (JP5964)

Cambridge, MA · Biotech/Pharmaceutical
Job Title: Sr Engineer (JP5964)
Location: Cambridge, MA
Employment Type: Contract- The position will require domestic travel to both Amgen and supplier sites - approximately 10-20%. 
Duration: 6 months with likely extensions
 
3Key Consulting is looking for a Sr Engineer for a leading, international pharmaceutical company headquartered in Thousand Oaks, CA.
 
Ideal candidate - Degree in Materials Sciences, Engineering, or other Life Sciences field. Project management experience in a lead role (define, approve, develop milestones and metrics; oversee budget). Lean or Six Sigma project experience conducting Kaizens events. Strong understanding of GMP manufacturing requirements. Experience with single use technologies used in biopharmaceutical manufacturing. 
 
The manager would like to see resumes with a more focus on LEAN and project management then on SUS technical knowledge

The primary responsibility of this position will be to manage a cross-functional initiative to harmonize and improve the defect library for visual inspection of Single-Use System (SUS) assemblies across Amgen sites. This is a high visibility position requiring a combination of strong technical, project management, and communication skills to interface with both Amgen personnel and key suppliers. 
 
The position will require domestic travel to both Amgen and supplier sites - approximately 10-20%. 

Key tasks include: 
• Conduct and analyze voice of customer (VOC) surveys with Amgen manufacturing sites to get feedback on use of defect library manual, use of visual inspection tools, and format/content improvements. 
• Partner with key suppliers and Amgen manufacturing sites to: 
o Align on consistent terminology for film defect types and establish clear acceptance and rejection criteria 
o Revise defect library to provide clear acceptance criteria, including defect images and appropriate tools for inspection 
o Develop protocols and execute testing to establish data-driven acceptance criteria 
• Manage Authoring, Review and Approval of revised defect library manual in documentation control management system 
• Develop Amgen staff training materials on use of defect library and visual inspections tools 
• Develop project plan to expand scope of current defect library manual to include other types of defects and key suppliers.



Preferred Qualifications: 
• PhD Degree in Materials Sciences, Engineering, or other Life Sciences field. 
• Project management experience in a lead role (define, approve, develop milestones and metrics; oversee budget). 
• Strong understanding of single use technologies used in biopharmaceutical manufacturing 
• Lean or Six Sigma project leadership experience conducting Kaizens events 
• Self-driven mentality and Ability to learn new tasks, functions and responsibilities quickly 
• Continuous improvement mindset 
• Analytical reasoning and creative problem-solving ability 
• Effective written and oral communication/presentation skills 
• Strong project management skills, including advanced proficiency with project management tools 
• Ability to operate in a team or matrixed environment 
• Advanced skills using Amgen systems such as SAP, Microsoft Office Suite, EDMQ, QMTS and data visualization software (Tableau, Power BI, Spotfire) 
• Demonstrated technical writing, negotiation and facilitation skills 
• Strong understanding of GMP manufacturing requirements
 

Top Must have Skill Sets:
• Strong understanding of single use technologies used in biopharmaceutical manufacturing
• Strong project management skills, including advanced proficiency with project management tools
• Demonstrated technical writing, negotiation and facilitation skills
 
Red Flags: Lack of experience in Single-use systems, Material Sciences, or Engineering
Lack of technical project management experience
Inability for domestic travel
 
Interview Process:
Phone interview with manager and team member
In person round table interview with team members
 
We invite qualified candidates to send your resume to resumes@3keyconsulting.com. If you decide that you’re not interested in pursuing this position, please feel free to look at other positions on our website www.3keyconsulting.com. You are welcome to also share this posting with anyone you think might be interested in applying for this role.
 
 
 
 
 
Regards,
 
3KC Talent Acquisition Team
 
 
Powered by