Manufacturing Associate-LAN

Emergent BioSolutions • Lansing, MI

4d

About The Position

The Manufacturing Associate executes tasks in accordance with current Good Manufacturing Practices (CGMP) and Standard Operating Procedures to manufacture, inspect, and package Anthrax Vaccine Adsorbed. The role requires completing training and maintaining competence through the manufacturing training program, while applying Emergent BioSolutions’ values in daily work.

The associate performs and documents manufacturing activities, maintains cleanroom and facility conditions, reviews documentation in real time, and supports inventory and continuous-improvement programs. Depending on the assigned operation, work includes preparation, upstream and downstream processing, inspection, labeling, and packaging. These activities involve validated equipment and configurations, automated control systems, detailed process documentation, and strict controls intended to maintain sterile conditions and product quality.

Requirements

• High school diploma.
• One to two years of experience working in a CGMP environment.
• Personal competencies: self-awareness, integrity, teamwork, creativity, and cultural awareness.

Nice To Haves

• Knowledge of CGMP and CFR requirements.

Responsibilities

• Complete assigned manufacturing qualification training and demonstrate competency in accordance with the training progression pathway.
• Execute and document procedural steps in compliance with CGMP standards, cleanroom behavior requirements, and Standard Operating Procedures.
• Comply with applicable company and industry rules and regulations, including FDA CGMP, GDP, and environmental, health, and safety requirements.
• Maintain facility environmental control, prepare cleaning solutions, and clean manufacturing areas on required schedules.
• Review process documentation, including batch production records, forms, and logs, for accuracy and completeness as work is performed.
• Stock gowning and consumable supplies in controlled areas and maintain Kanban inventory control of manufacturing materials.
• Follow standard work guidelines and participate in Integrated Process Team continuous-improvement activities, Kanban, and 6S programs.
• Complete inspector qualification requirements and identify, classify, and cull product defects, including defects that could affect patient safety.
• Operate labeling equipment with minimal supervision after qualification.
• Apply traceability and expiration information to secondary packaging components and inspect printed cartons and cases for suitability.
• Package product in secondary and final packaging components and reconcile product rejects.
• Complete ambient tracking documentation and use designated SAP modules to issue materials and confirm process steps.
• Prepare media by precisely weighing and hydrating components; operate parts washers and sterilization or decontamination processes using validated load configurations.
• Assemble clean process glassware configurations and portable tanks using sanitary connections, quick connects, and stainless-steel ancillary parts.
• Clean and sterilize production vessels using cleaning and sterilization processes and an automated control system.
• Prepare and dispense intermediate materials.
• Perform upstream processing, including cleaning and sterilizing fermenters and media filters, preparing and sterilizing media, inoculating fermenters, monitoring culture turbidity, transferring cultures between vessels, adjusting culture pH, installing and integrity-testing sterilizing-grade filters, and filtering culture into a harvest tank.
• Perform downstream operations, including adding ALOH to the harvest tank, drawing and submitting samples through LIMS, cleaning and sterilizing harvest tanks and centrifuges, operating centrifugation processes, and dispensing and sterilizing ALOH.
• Collaborate and communicate effectively, manage conflict, make timely decisions, solve complex problems, prioritize work, and support team engagement in alignment with company values.

Benefits

• Comprehensive benefits package.
• Certain roles are eligible for merit increases, annual bonuses, and/or long-term incentives in the form of stock options.

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Education Level: High school or GED