NPI / MES Manufacturing Specialist
| Company | Amgen |
|---|---|
| Location | Thousand Oaks, CA, USA |
| Salary | $112977 – $139179 |
| Type | Full-Time |
| Degrees | Bachelor’s, Master’s, PhD, Associate’s |
| Experience Level | Mid Level, Senior |
Requirements
- Doctorate degree
- Master’s degree and 2 years of GMP manufacturing experience
- Bachelor’s degree and 4 years of GMP manufacturing experience
- Associate’s degree and 8 years of GMP manufacturing experience
- High school diploma / GED and 10 years of GMP manufacturing experience
Responsibilities
- Working with NPI support groups to develop, maintain, and implement the NPI project plan(s), being accountable for NPI scope, schedule, risk management, and leading matrixed teams through influence to meet NPI project achievements.
- Leading cross-functional cases to ensure that the plant is operating according to its long-term strategy.
- Resolving issues in a timely manner and elevating cross-functional customer concern to various levels of management as appropriate.
- Owning Change Controls in Trackwise, ensuring records are comprehensive and compliant per GMP regulatory procedures, on a Right-First-Time basis.
- Proactively leading cross-functional team meetings, to ensure project(s) and other relevant cases complete per schedule.
- Succinctly communicating verbally, in writing, and through presentations to peers and senior leadership team.
- Generate and validate Manufacturing Electronic Batch Record (EBR) using Kroeber PAS|X.
- Assist in implementation of new MES functionality – Equipment Management (EQM), PCS MBR Elements, Level 2 Integration.
- Contribute to Lean Transformation through recording NPI/EBR metrics and application of continuous improvement tools.
- Engage with the rest of the Amgen network to assess EBR differences and identify path forward toward higher-effectiveness way-of-working.
- Provide on-call support to Manufacturing Operators, as needed.
Preferred Qualifications
- Project Management experience
- Direct and/or indirect people management / leadership experience
- Understanding of Drug Product Formulation and Vial/Syringe Filling operations
- Experience with various quality systems including change control, deviations, corrective and preventative actions, and/or validation practices
- Experience with Kroeber PAS|X, SAP, and system integration platforms such as Kepware Middleware, PI Historian, Rockwell etc.
- Strong organization and technical writing skills; able to articulate complex problems concisely with technical and management staff
- Independent, self-motivated, able to multi-task in a fast-paced environment
- Team-player
- Demonstrated flexibility and ability to manage change
- Direct experience with regulated environments (e.g., cGMP etc.)