Specialist Manufacturing – Contamination Control Process Owner

Amgen•Holly Springs, NC

3d•$107,545 - $145,503

About The Position

The Contamination Control Process Owner (PO) works within the Manufacturing Support organization at Amgen North Carolina (ANC). The role owns assigned operational processes and procedures supporting contamination controls, including facility and environmental control, aseptic behavior, in-process bioburden and endotoxin controls, and equipment cleaning and sanitization. The PO implements Contamination Control Strategy (CCS) requirements in assigned processes, maintains inspection readiness, and coordinates process assessments and improvement actions. For issues or proposed updates with broader CCS implications, the PO works with the Contamination Control Site Lead and/or the Amgen Contamination Control Network. The PO serves as a subject-matter expert in contamination control and aseptic/cleanroom behavior. Responsibilities include implementing CCS requirements, identifying procedure or execution gaps, supporting quality risk assessments, and owning processes and assigned SOPs for gowning, cleaning, and material flow. The PO also supports microbial awareness training, maintains inspection-ready procedures, training, evidence and records, responds to audit and inspection questions within scope, and contributes process expertise to deviation investigations, CAPAs, change controls, trend monitoring, and effectiveness checks.

Requirements

Doctorate degree and 2 years of biotechnology operations experience; or master’s degree in Engineering, Biology, Chemistry, Biochemistry, or a related field and 4 years of biotechnology operations experience; or bachelor’s degree and 6 years of biotechnology operations experience; or 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; identify procedure or execution gaps and provide process information and proposed updates to the Site Lead and/or contamination control network.
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 PO’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 microbial awareness training needs; provide relevant examples, support delivery and reinforcement, and share questions or recurring behavior gaps.
Maintain inspection readiness through current and usable procedures, aligned training, implementation evidence, records, and clear explanations of assigned processes; prepare process evidence and participate in mock interviews.
Answer regulatory inspection and audit questions about assigned processes using approved procedures and records, provide requested evidence, support assigned response actions, and escalate out-of-scope questions or broader risks.
Support root cause analyses with process expertise and own or coordinate process-level CAPAs and change controls within the PO’s scope.
Track assigned process issues and actions, verify local changes are implemented, and report repeat issues or weak controls to the Site Lead.