MSD Malaysia
* 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 #J-18808-Ljbffr
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 #J-18808-Ljbffr