Associate Specialist, Manufacturing Engineer; Onsite

Position: Associate Specialist, Manufacturing Engineer (Onsite)
* 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
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