Associate Technician, Operations

Associate Tech, Operations

Bio Process Operations Technician 1st Shift

• Execute manufacturing operations and facility disinfection
• Set up and perform aseptic vaccine manufacturing to include primary filling, inspection, packaging, CIP/SIP, and additional equipment within qualified parameters
• Identify potential equipment problems and partner with Vaccines Maintenance Technicians to ensure appropriate resolution. Demonstrate ability to troubleshoot process, electronic systems, and equipment for routine and basic problems.
• Perform other duties as requested by the Operations coach

• Accountable for performing work in a safe manner, following identified safety procedures (hazardous work permitting, LOTO, HECPs), and using applicable safety equipment / personnel protective equipment (PPE)
• Execute operations functions in accordance with current Good Manufacturing Practices (cGMPs) and standard operating procedures (SOPs)
• Complete documentation in electronic batch records, electronic logs, and other systems in accordance with site procedure
• Maintain good housekeeping and 5S in assigned work area
• Adhere to the highest level of data integrity while performing duties
• Identify potential quality or safety issues. Escalate as per IPT management processes and assist in the investigation, root cause determination, and CAPA implementation.

• Ensure that startup activities for area of assignment are executed such that deliverables and timelines are met
• Closely monitor team / process performance and improve reliability through problem solving and continuous improvement
• Set up and operate equipment in alignment with established training and procedures to ensure reliable operation with minimal delays or discards
• Identify and help implement continuous improvement and productivity enhancements within the IPT

• Partner with Technicians and cross-functional groups for assigned area
• Demonstrate a high degree of maturity and personal integrity. Strictly adhere to all site policies on personal conduct and attendance.
• Train, develop, and mentor other team members to share experience and best practices
• Pursue knowledge and skills in assigned area from an operations perspective and share that information readily with team
• Maintain a culture of continuous improvement / MPS focused on standard work, making problems visible, minimizing waste, reducing process variability, and problem solving
• Routinely demonstrates leadership and conflict-resolution ability. Demonstrates a willingness to provide and receive constructive feedback in 360° performance review.

• Solid line report to:
  Manager, Maintenance & Operations
• Dotted line report to: N/A
• Position(s) reporting to this position: N/A (individual contributor)

• 8hrs 06:00AM-02:30PM

• High School diploma or equivalent

• This is an entry level position and 1 year or more of experience in a GMP manufacturing facility is preferred (aseptic GMP environment strongly preferred).
• Demonstrated ability to work independently and as team member
• Demonstrated interpersonal skills with ability to influence and assist others through a culture of inclusion, feedback, and empowerment
• Ability to gown and work in an aseptic environment
• Demonstrated ability to work with computerized and automated systems.
• Willing to work irregular hours to support multi-shift operation on an as needed basis

• Associates degree in Business, Science, or Technology-based field and/or bio-pharma focused certificates, such as Bioworks, preferred.
• Experience with aseptic filling, visual inspection systems, CIP/SIP systems, packaging equipment and similar aseptic formulation and filling operations
• Experience operating, maintaining, troubleshooting, and/or repairing industrial equipment
• Experience working in a regulated environment (FDA, etc.) and basic knowledge of cGMPs as they apply to the vaccine/pharmaceutical industry
• Experience in Continuous Improvement, Lean Manufacturing, Problem Solving, and/or Right First-Time methodologies
• SAP / MES / electronic logbook basic knowledge from a production execution perspective
• Demonstrated leadership ability, peer training experience, and/or productivity improvement activities
• Demonstrated ability and drive to work autonomously and help organize priorities and work with other team members
• Outstanding communication skills both within direct team and across multiple shifts to ensure…