Bio Process Operations Technician

* Execute manufacturing operations, environmental monitoring, and facility disinfection within the Pod vaccine manufacturing facility
* Set up and operate CIP / SIP, aseptic primary filling, packaging, inspection and additional support equipment within qualified parameters
* Identify potential equipment problems and partner with other Bio Process 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
* Responsible 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 batch records, electronic logs, or 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 support groups for assigned area to maintain an inclusive and positive work environment
* 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 in a GMP manufacturing facility (Aseptic/Cleanroom/Sterile Fill GMP environment strongly preferred)
* Ability to work independently as Team member
* Interpersonal skills with ability to influence and support others through a culture of inclusion, feedback, and empowerment
* Leadership ability, peer training experience, and/or productivity improvement activities strongly preferred.
* Ability to gown and work in an aseptic environment
* Ability to work with computerized and automated systems
* Willing to work irregular hours to support multi-shift operation on an as needed basis
* Aseptic filling, visual inspection systems, CIP/SIP systems, packaging equipment and similar aseptic formulation and filling operations (Strongly Preferred)
* Working in a regulated environment (FDA, etc.) and basic knowledge of cGMPs as they apply to the vaccine/pharmaceutical industry
* Continuous Improvement, Lean Manufacturing, Problem Solving, and/or Right First-Time methodologies
* SAP/MES/electronic log book basic knowledge from a production execution perspective
* 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
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