Specialist Manufacturing - Contamination Control Process Owner

Career Category

Job Description

HOW MIGHT YOU DEFY IMAGINATION

Youveworked hard to become the professional you are today and are now ready to take the next step in your career. How will you put your skills experienceand passion to work toward your goals At Amgen our shared missionto serve patientsdrives all that we do. It is key to our becoming one of the worlds leading biotechnology companies reaching over10 million patientsworldwide. Come do your bestworkalongside other innovative driven professionals in this meaningful role.

Be part of Amgens newest and most advanced drug substance manufacturing plant. When completed the AmgenFleXBatch facility will combine the latest in disposable technologies with traditional stainless-steel equipment to allow for maximum flexibility in operations. TheFleXBatch facility will not only feature the best in-class drug substance manufacturing technologies with embedded industry 4.0 capabilities but it will also integrate sustainability innovations to reduce carbon and waste as part of Amgens plan to be a carbon-neutral company by 2027.

Specialist Manufacturing Contamination Control Process Owner

Live

What You Will Do

In this vital role you will serve as a Contamination Control Process Owner (PO) within the Manufacturing Support organization at Amgen North Carolina (ANC). The Contamination Control PO owns assigned operational processes and procedures that support the contamination controls which encompasses facility control environmental control aseptic behavior program in-process bioburden & endotoxin controls and equipment cleaning & sanitization. The PO implements the Contamination Control Strategy (CCS) requirements within the assigned processes maintains audit inspection readiness and coordinates process-level assessments and improvement actions. The PO works with the Contamination Control Site Lead and/or Amgen Contamination Control Network when issues or proposed updates have broader CCS implications.

The contamination control PO serves as the contamination control and aseptic/cleanroom behavior Subject-Matter-Expert (SME) coordinates with the contamination control site lead and contamination control network to implement and support continuous improvement as follows:

• Contamination Control Strategy: Implement CCS 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.
• Quality Risk Assessments: Supply process details identify hazards and existing controls and implement assigned actions. Lead or contribute to local process assessments for changes within the POs scope with Site Lead input when risks have broader CCS implications.
• Process and Procedure Ownership: Own the operational processes and assigned SOPs for gowning cleaning and material flow including procedure content process sequence supplies and equipment need training impacts implementation and routine improvement.
• Microbial Awareness Training: Identify affected roles and process-specific training needs; provide realistic examples from gowning cleaning and material flow; support delivery and reinforcement in assigned areas; and share questions or recurring behavior gaps. Own procedure-linked training impacts for assigned processes.
• Inspection Readiness: Maintain current usable procedures; aligned training; implementation evidence; records; and clear explanations of how assigned processes are performed and controlled. Prepare process evidence and participate in mock interviews.
• Regulatory Inspections and Audit Responses: Answer questions about assigned processes using approved procedures and records provide requested evidence and support assigned response actions. Escalate questions outside the POs scope or that indicate broader risk. Participate in inspection readiness activities and support audits as required.
• Deviation Investigations CAPAs and Change Controls: Support root cause analyses (RCAs) with process expertise and own or coordinate process-level corrective and preventive actions (CAPAs) and change controls assigned to the POs scope.
• Trends and Effectiveness Checks: Track assigned process issues and actions check that local changes are implemented and report repeat issues or weak controls to the Site Lead.

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What We Expect of You

Basic Qualifications

• Doctorate degree and 2 years of biotechnology operations experience OR

• Masters degree in Engineering Biology Chemistry Biochemistry or related field and 4 years of biotechnology operations experience OR

• Bachelors degree and 6 years of biotechnology operations experience OR

• Associates degree and 10 years of biotechnology operations experience OR

• High school diploma / GED and 12 years of biotechnology operations experience

Preferred Qualifications

• 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.

Thrive

As we work to develop treatments that take care of others we also work to care for our teammates professional and personal growth and well-being through comprehensive benefits career development opportunities and a collaborative culture

Salary Range

Required Experience:

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