Specialist Manufacturing: Manufacturing Execution System (MES)

Amgen•Holly Springs, NC

12d•Onsite

About The Position

Amgen is seeking a Specialist Manufacturing: Manufacturing Execution System (MES) to join their newest and most advanced drug substance manufacturing plant, the Amgen FleX Batch facility. This role will serve as a key interface between GMP manufacturing teams and Process Development scientific groups, ensuring the accuracy of Electronic Batch Records. The position is responsible for driving batch record optimization, supporting troubleshooting and problem-solving, and championing continuous improvement initiatives. The Specialist will also act as the primary liaison between the site MES and the global MES team for Generic Master Batch Record (GMBR) optimizations and will respond to regulatory inquiries and audit findings.

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, and lead team improvement initiatives to drive improved productivity on the manufacturing floor.
Coordinate with Global MES Team, Manufacturing, Process Development, Process Owner, and Quality to create and modify electronic batch records.
Support the implementation of new products and/or technologies into the plant.
Lead and/or participate 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 (RCAs).
Support CAPA development to prevent error recurrence.
Own Generic Master Batch Record (GMBR) optimizations.
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 OE initiatives.
Facilitate the drive towards continuous improvement in the plant and track progress on a plant level.
Support batch record standardization to enable network-wide usage of generic batch records.