MSD Malaysia
Associate Specialist, Manufacturing Engineer (Onsite)
MSD Malaysia, Rahway, New Jersey, us, 07065
* Lead process improvement activities in the oral solid dosage facility* Coordinate quick changeover activities on designated equipment trains* Define and improve standard work, SOPs, BTD, and overall production flow* Support standard Non-Sterile
processing as time allows* Ensure adherence to Good Manufacturing Practices, draft and review process steps, SOP's, quality procedures, safety, and environmental standards.* Perform documentation activities on room and equipment logs and batch sheets in compliance with Good Documentation Practices.* Develop experience to become a compliance and continuous improvement expert and share knowledge by teaching others.* Execution of GMP batch documentation in accordance to local and global operating procedures.* Provide support to engineering and formulations staff on Good Manufacturing Practices, facility processes, facility maintenance and batch specific items.* Identify and document deviations and atypical events.* Lead investigations and document as required.* Execute equipment swabbing in support of the cleaning verification program.* Support investigations and the implementation of corrective/preventive actions.* Support external and internal audits, tours and inspections.* Author or assist with the development of SOP's.* Complete training and ensure it is up to date.* Interface with engineering, safety, quality and maintenance personnel for improvement of our current processes.* Lead improvement initiatives.* Bachelor’s in Chemical Engineering, Pharmaceutical Sciences, Chemistry or related fields* Independent planning, scheduling, and time management skills.* Must pass medical screening requirements for production with PAPR (powered air purifying respirators)* Ability to move 50 lbs.* Ability to troubleshoot and resolve issues utilizing digital skill sets* Experience in GMP pharmaceutical plant operations* Experience with GMP (Good Manufacturing Practices) and GDP (Good Documentation Practices)* Working knowledge of regulatory requirements within GMP manufacturing facilities, and demonstrated focus on details and proper execution of batch manufacturing.* Experience with some of the following: Oral Solid Dosage, Tablet Compression, Encapsulation, Spray Drying, Film Coating, Dry Powder Inhalers, Drug Product Device assembly lines, Isolators, Containment technology* Experience working with Lean / Six Sigma and continuous improvement projects* Experience with: PI Visions, Equipment HMI use, SAP, Calibration/Maintenance Database Systems, Microsoft Office (Word, Excel and Outlook).* Experience working with safety team on industrial hygiene monitoring, investigations, improvements, and focus on safety working culture.**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
processing as time allows* Ensure adherence to Good Manufacturing Practices, draft and review process steps, SOP's, quality procedures, safety, and environmental standards.* Perform documentation activities on room and equipment logs and batch sheets in compliance with Good Documentation Practices.* Develop experience to become a compliance and continuous improvement expert and share knowledge by teaching others.* Execution of GMP batch documentation in accordance to local and global operating procedures.* Provide support to engineering and formulations staff on Good Manufacturing Practices, facility processes, facility maintenance and batch specific items.* Identify and document deviations and atypical events.* Lead investigations and document as required.* Execute equipment swabbing in support of the cleaning verification program.* Support investigations and the implementation of corrective/preventive actions.* Support external and internal audits, tours and inspections.* Author or assist with the development of SOP's.* Complete training and ensure it is up to date.* Interface with engineering, safety, quality and maintenance personnel for improvement of our current processes.* Lead improvement initiatives.* Bachelor’s in Chemical Engineering, Pharmaceutical Sciences, Chemistry or related fields* Independent planning, scheduling, and time management skills.* Must pass medical screening requirements for production with PAPR (powered air purifying respirators)* Ability to move 50 lbs.* Ability to troubleshoot and resolve issues utilizing digital skill sets* Experience in GMP pharmaceutical plant operations* Experience with GMP (Good Manufacturing Practices) and GDP (Good Documentation Practices)* Working knowledge of regulatory requirements within GMP manufacturing facilities, and demonstrated focus on details and proper execution of batch manufacturing.* Experience with some of the following: Oral Solid Dosage, Tablet Compression, Encapsulation, Spray Drying, Film Coating, Dry Powder Inhalers, Drug Product Device assembly lines, Isolators, Containment technology* Experience working with Lean / Six Sigma and continuous improvement projects* Experience with: PI Visions, Equipment HMI use, SAP, Calibration/Maintenance Database Systems, Microsoft Office (Word, Excel and Outlook).* Experience working with safety team on industrial hygiene monitoring, investigations, improvements, and focus on safety working culture.**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