Specialist Manufacturing – Contamination Control Process Owner

Amgen•Holly Springs, NC

About The Position

Serve as a Contamination Control Process Owner within the Manufacturing Support organization at Amgen North Carolina. The role owns assigned operational processes and procedures that support contamination controls, including facility and environmental control, aseptic behavior, in-process bioburden and endotoxin controls, and equipment cleaning and sanitization. The Process Owner implements Contamination Control Strategy requirements within assigned processes, maintains inspection readiness, and coordinates process-level assessments and improvement actions. Broader Contamination Control Strategy issues or proposed updates are coordinated with the Contamination Control Site Lead and/or Amgen Contamination Control Network. The role serves as a subject-matter expert in contamination control and aseptic/cleanroom behavior. It owns operational processes and assigned SOPs for gowning, cleaning, and material flow, including procedures, process sequence, supplies and equipment needs, training impacts, implementation, and routine improvement. The Process Owner also supports microbial awareness training, quality risk assessments, inspections and audits, deviation investigations, CAPAs, change controls, and monitoring of trends and effectiveness.

Requirements

One of the following: Doctorate degree and 2 years of biotechnology operations experience; Master's degree in Engineering, Biology, Chemistry, Biochemistry, or a related field and 4 years of biotechnology operations experience; Bachelor's degree and 6 years of biotechnology operations experience; Associate's degree and 10 years of biotechnology operations experience; or high school diploma/GED and 12 years of biotechnology operations experience.

Nice To Haves

Technical expertise in Upstream Manufacturing, Downstream Manufacturing, or Manufacturing Services (Raw Material Dispensing and Solution Preparation).
Strong technical knowledge of aseptic operations (hood operations) and cleanroom behaviors in manufacturing areas.
Experience supporting GMP manufacturing operations in a biotechnology or pharmaceutical environment.
Experience authoring and maintaining GMP documentation, including SOPs and manufacturing procedures.
Experience supporting manufacturing change controls and implementation activities.
Experience participating in risk assessments, root cause analyses, investigations, and CAPA implementation activities.
Experience supporting CAPA applicability assessments and effectiveness checks.
Strong technical writing, communication, problem-solving, and organizational skills.

Responsibilities

Implement Contamination Control Strategy requirements in assigned processes and identify procedure or execution gaps.
Provide process information and proposed updates to the Contamination Control Site Lead and/or contamination control network when needed.
Supply process details, identify hazards and existing controls, and implement assigned actions for quality risk assessments.
Lead or contribute to local process assessments for changes within the role’s scope.
Own operational processes and assigned SOPs for gowning, cleaning, and material flow, including procedure content, process sequence, supplies and equipment needs, training impacts, implementation, and routine improvement.
Identify affected roles and process-specific training needs; provide realistic examples; support training delivery and reinforcement; and report questions or recurring behavior gaps.
Maintain current, usable procedures, aligned training, implementation evidence, records, and clear explanations of assigned processes.
Prepare process evidence and participate in mock interviews, inspection-readiness activities, and audits as required.
Answer regulatory inspection and audit questions about assigned processes using approved procedures and records, provide requested evidence, and support assigned response actions.
Escalate questions outside the role’s scope or that indicate broader risk.
Support root cause analyses and own or coordinate process-level corrective and preventive actions and change controls within the role’s scope.
Track assigned process issues and actions, verify that local changes are implemented, and report repeat issues or weak controls to the Site Lead.