Specialist Manufacturing: Manufacturing Execution System (MES)

Amgen•Holly Springs, NC

10d

About The Position

Amgen is seeking a Specialist Manufacturing, Manufacturing Execution System (MES) for its newest and most advanced drug substance manufacturing plant, the Amgen FleX Batch facility. This facility combines disposable technologies with traditional stainless-steel equipment for operational flexibility and features industry 4.0 capabilities and sustainability innovations. The role involves communicating and interfacing between GMP manufacturing teams and Process Development scientific groups, ensuring accurate electronic batch records, and driving batch record optimization. This is a highly visible role within the Manufacturing Support team, offering opportunities for improvement initiatives and enhanced productivity.

Requirements

Doctorate degree OR Master’s degree in chemistry, biology, or engineering & 3 years of biotechnology operations experience OR Bachelor’s degree and 5 years of biotechnology operations experience OR Associate’s degree & 10 years of biotechnology operations experience OR High school diploma / GED & 12 years of biotechnology operations experience
Excellent cross-functional project management, meeting facilitation, and technical writing skills.
Strong technical knowledge of drug substance processing (Inoculation, Bioreactors, Harvest, chromatography, filtration, buffer preparation) and a broad understanding of related disciplinary areas in bioprocessing.
Extensive experience with electronic batch record design in Koerber PAS|X or comparable software for electronic batch records with some understanding of editing and validation.
Ability to effectively communicate complex technical information with internal and external colleagues of varying organizational levels in both presentation and technical writing forms.
Ability to coach, mentor and/or cross train colleagues within core technical areas.

Nice To Haves

Degree in Chemical Engineering, Industrial Engineering, Biology, or Biochemistry
Experience in GMP manufacturing operations

Responsibilities

Communicate and interface between GMP manufacturing teams and Process Development scientific groups.
Ensure all Electronic Batch Records accurately document the manufacturing process.
Drive batch record optimization between the manufacturing floor and the global MES team.
Propose, participate in, and lead team improvement initiatives to drive improved productivity on the manufacturing floor.
Coordinate with the Global MES Team, Manufacturing, Process Development, Process Owner, and Quality to create and modify electronic batch records for new products and/or technologies.
Act as a Subject Matter Expert who leads and/or participates in projects, ensuring electronic batch records accurately and effectively record all necessary process data for unit operations in Koerber PAS|X.
Support Manufacturing in troubleshooting, problem-solving, and Root Cause Analysis (RCA).
Support CAPA development to prevent error recurrence.
Own Generic Master Batch Record (GMBR) optimizations and act as the primary liaison between the site MES and global MES team to drive on-time deliveries of GMBRs.
Respond to regulatory questions and/or audit findings.
Champion Lean Transformation and Operational Excellence (OE) initiatives, driving continuous improvement in the plant and tracking progress.
Support batch record standardization to enable network-wide usage of generic batch records.