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Key Responsibilities and Required Skills for Vaccine Operator

💰 $45,000 - $85,000

BiotechnologyManufacturingPharmaceuticalScienceOperations

🎯 Role Definition

As a Vaccine Operator, you are at the very heart of modern medicine, playing a critical role in the large-scale production of life-saving vaccines. You will be a hands-on contributor within a state-of-the-art cGMP (Current Good Manufacturing Practices) facility, responsible for executing the precise manufacturing steps that transform raw materials into finished vaccine products. This role requires a blend of technical expertise, unwavering attention to detail, and a deep commitment to quality and safety. You will be part of a dynamic team dedicated to ensuring a consistent and reliable supply of vaccines to protect global public health.

📈 Career Progression

Typical Career Path

Entry Point From:

  • Biotechnology Program Graduate (Associate's or Bachelor's)
  • Quality Control Lab Technician
  • Chemical Plant Operator or Technician

Advancement To:

  • Senior or Lead Vaccine Operator
  • Manufacturing Supervisor or Team Lead
  • Process Development Scientist

Lateral Moves:

  • Quality Assurance (QA) Specialist
  • Validation Technician
  • Manufacturing Sciences and Technology (MSAT) Associate

Core Responsibilities

Primary Functions

  • Execute upstream manufacturing processes, including media and buffer preparation, cell culture expansion, and operation of single-use or stainless-steel bioreactors to grow cell lines.
  • Operate and monitor downstream purification equipment, such as chromatography skids, tangential flow filtration (TFF) systems, and viral filtration apparatus, to isolate and purify the target antigen.
  • Perform aseptic filling operations within an ISO-classified cleanroom environment, ensuring the sterility and integrity of the final vaccine product.
  • Meticulously complete and review Batch Production Records (BPRs) and other manufacturing documentation in real-time, ensuring compliance with Good Documentation Practices (GDP).
  • Conduct routine cleaning, sterilization (CIP/SIP), and maintenance of all manufacturing equipment to ensure operational readiness and prevent cross-contamination.
  • Operate in a strictly controlled cGMP environment, adhering to all safety protocols and procedures, including proper gowning and handling of biohazardous materials.
  • Perform in-process sampling and testing (e.g., pH, cell density, bioburden) to monitor process performance and ensure product quality at critical control points.
  • Troubleshoot equipment alarms and minor process deviations, identifying root causes and implementing corrective actions in collaboration with engineering and senior staff.
  • Weigh, dispense, and stage critical raw materials according to the batch record, verifying identity, lot numbers, and expiration dates before use.
  • Monitor and control critical process parameters (CPPs) using automated control systems like DeltaV or SCADA, ensuring the process remains within its validated state.
  • Participate in the assembly and disassembly of complex processing equipment, performing integrity testing on filters and components before and after use.
  • Execute environmental monitoring within the cleanroom suites, including surface, air, and personnel sampling, to maintain a state of microbial control.
  • Support validation activities for new equipment and processes (IQ/OQ/PQ) by executing protocols and documenting results.
  • Manage the inventory and logistics of single-use components and consumables, ensuring adequate supply for scheduled production runs.

Secondary Functions

  • Support investigations into process deviations, non-conformances, and out-of-specification (OOS) results by providing detailed information and operational insights.
  • Assist in the creation and revision of Standard Operating Procedures (SOPs), batch records, and training materials to reflect current practices and process improvements.
  • Train and mentor junior operators on equipment operation, aseptic technique, and cGMP compliance, fostering a culture of continuous learning.
  • Collaborate with cross-functional teams, including Quality Assurance, Quality Control, and Engineering, to resolve manufacturing issues and drive process efficiency.
  • Participate in continuous improvement projects (e.g., Kaizen, 5S) to enhance safety, quality, and productivity within the manufacturing suite.
  • Support technology transfer activities for new products or processes, working alongside Process Development teams to scale up and implement manufacturing runs.

Required Skills & Competencies

Hard Skills (Technical)

  • cGMP Knowledge: Deep understanding of current Good Manufacturing Practices as defined by regulatory bodies like the FDA and EMA.
  • Aseptic Technique: Proven ability to perform tasks in a sterile manner to prevent microbial contamination.
  • Bioreactor Operation: Experience with the setup, operation, and monitoring of cell culture bioreactors (single-use or stainless steel).
  • Downstream Processing: Hands-on skill with chromatography, Tangential Flow Filtration (TFF), and other purification technologies.
  • Good Documentation Practices (GDP): Meticulous and accurate record-keeping on batch records and logbooks.
  • Equipment Troubleshooting: Ability to diagnose and resolve common alarms and issues with manufacturing equipment.
  • Cleanroom Gowning & Conduct: Proficiency in proper gowning procedures and maintaining a state of control in ISO-classified environments.
  • Buffer/Media Preparation: Experience with precise weighing, mixing, and filtration of process solutions.
  • Process Control Systems: Familiarity with automated systems like DeltaV, SCADA, or other manufacturing execution systems (MES).

Soft Skills

  • Attention to Detail: An unwavering focus on precision and accuracy, as minor errors can have significant consequences.
  • Teamwork & Collaboration: Ability to work effectively within a team and communicate clearly with cross-functional partners.
  • Problem-Solving: A logical and systematic approach to identifying issues and implementing effective solutions under pressure.
  • Adaptability: Flexibility to work various shifts (including nights and weekends) and adapt to changing production schedules and priorities.
  • Communication: Strong verbal and written communication skills for reporting process status and documenting events.
  • Time Management: Excellent organizational skills to manage multiple tasks and complete them within strict timelines.
  • Commitment to Quality: A personal and professional dedication to producing a safe and effective product.

Education & Experience

Educational Background

Minimum Education:

High School Diploma or GED with relevant technical certification or direct experience.

Preferred Education:

Associate's or Bachelor's Degree in a scientific or technical discipline.

Relevant Fields of Study:

  • Biotechnology
  • Biology
  • Chemistry
  • Chemical Engineering

Experience Requirements

Typical Experience Range: 1-5 years of hands-on experience in a regulated manufacturing environment.

Preferred: Direct experience in a biopharmaceutical or vaccine manufacturing facility operating under cGMP guidelines is highly desirable.

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