Tech, Bio Process Operations

* 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.
* 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.
* Three or more years of experience in a GMP manufacturing facility (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 success of overall team
* Ability to support technical writing of documents such as standard operating procedures (SOPs)
** Los Angeles Residents Only:
** We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles’ Fair Chance Initiative for Hiring Ordinance
#J-18808-Ljbffr