Assistant Manufacturing Associate

Role Summary

Execute tasks per CGMP guidelines and Standard Operating Procedures to manufacture, inspect and package Anthrax Vaccine Adsorbed. Complete training and maintain competence per the manufacturing training program. Actively incorporate the Shared Values set out by Emergent BioSolutions while performing day to day activities.

Responsibilities

• General: Complete training and demonstrate competency on Assistant Manufacturing Associate qualification blocks in accordance with the training progression pathway
• General: Execute and document procedural steps in compliance with CGMP standards, clean room behavior and Standard Operating Procedures
• General: Comply with all applicable rules and regulations of Emergent and the Pharmaceutical / Biotech industry. This includes FDA regulations such as CGMP, GDP, EH&S regulations, and company regulations such as the employee handbook
• General: Maintain state of facility environmental control including preparation of defined concentrations of cleaning solutions, daily, monthly, quarterly, and annual cleaning of manufacturing areas per Standard Operating Procedures
• General: Review all documentation for accuracy and completeness of process signature steps as each step is completed. Perform “real time” review of all documentation (BPRs, forms, logs, etc.) in the area throughout the shift
• General: Stock gowning and consumable supplies in the controlled areas maintaining Kanban inventory control of manufacturing materials

• Lean Concepts: Follow standard work guidelines
• Lean Concepts: Collaborate with applicable Integrated Process Teams to participate in continuous improvement and learn new Lean concepts
• Lean Concepts: Actively participate in Kanban and 6S programs

• Inspection and Packaging: Successfully complete inspector qualification requirements to identify, classify and cull product defects, including those defects which could impact patient safety (inspector qualification)
• Inspection and Packaging: Independently operate labeling equipment with minimal supervision (Qualification)
• Inspection and Packaging: Apply traceability and expiration information to secondary packaging components such as cartons and cases. Confirm suitability of secondary packaging components during printing processes through 100% inspection (carton printing, case creation)
• Inspection and Packaging: Package product in secondary and final packaging components while performing 100% reconciliation of product rejects (Packaging)
• Inspection and Packaging: Complete ambient tracking documentation
• Inspection and Packaging: Execute material issuance and confirmation of process steps using specific SAP modules

• Building 55 Operations – Prep: Execute material issuance and confirmation of process steps using specific SAP modules
• Building 55 Operations – Prep: Precisely weigh and hydrate media components
• Building 55 Operations – Prep: Load, run and unload parts washer and sterilization/decontamination using specific validated load configurations per Standard Operating Procedures
• Building 55 Operations – Prep: Assemble clean process glassware configurations and portable tanks utilizing sanitary connections, quick connects and stainless-steel ancillary parts
• Building 55 Operations – Prep: Perform Cleaning (COP/CIP) and Sterilizing (SOP/SIP) of production vessels through interface with automated control system (DeltaV)
• Building 55 Operations – Prep: Prepare and dispense intermediate materials

• Behavior/Cultural Responsibilities: Standing Shoulder to Shoulder (no matter what): working collaboratively with others, communicating, and managing conflict effectively
• Behavior/Cultural Responsibilities: Break Through Thinking: cultivating innovation and nimble learning
• Behavior/Cultural Responsibilities: Own It Always: ensuring accountability, and making good and timely decisions
• Behavior/Cultural Responsibilities: Compete Where It Counts: demonstrating courage and focusing on customers
• Behavior/Cultural Responsibilities: Integrity and Instills Trust: gaining the confidence and trust of others through honesty, integrity and authenticity
• Behavior/Cultural Responsibilities: Manages Complexity: making sense of complex, high quantity, and sometimes contradictory information to effectively solve problems
• Behavior/Cultural Responsibilities: Plans and Aligns: plan and prioritize work to meet commitments aligned with organizational goals
• Behavior/Cultural Responsibilities: Drives Engagement: creating a climate where people are motivated to do their best to help the organization achieve its objectives

Qualifications

• HS Diploma (Required)
• 0–1 year experience working in a CGMP environment (Required)
• Knowledge of CGMP and CFR requirements (Preferred)
• Personal Competencies: Self-awareness, Integrity, Team Player, Creative, and culturally aware (Required)

Skills

• Documentation and real-time review of manufacturing records and logs
• Attention to detail and adherence to CGMP standards
• Ability to operate labeling equipment
• Inventory management and Kanban practices
• Problem-solving and collaborative teamwork

Education

• HS Diploma