Associate Specialist, Manufacturing Engineer (Onsite)

MSD

2d • Onsite

About The Position

Pharmaceutical Operations and Clinical Supply is seeking a highly motivated individual for a Compliance and Continuous Improvement position to support specialty dosage forms and oral solid dosage GMP development activities. This role is primarily responsible for compliance and continuous improvement activities including safety, quality, delivery and continuous improvement within clinical supply Formulation Laboratory and Experimentation (FLEx) Center. This opening is for the Non-Sterile team in the 880 FLEx Center. The successful candidate will become an owner and trainer of our manufacturing support processes (safety, compliance, change overs, root cause analysis, continuous improvement program). They will lead the team through continuous improvement projects, along with managing and completing GMP documentation. They will also build a strong team dynamic through continual sharing of knowledge and identification of improvements. They will work closely with peer specialists, formulation scientists, facility engineers and automation engineers to fix processes/system issues and solve root causes. By taking initiative and owning improvement projects to completion, the candidate will help the team progress on our learning journey. This position is based in Rahway, NJ and is 100% on-site and day-shift.

Requirements

• 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
• Accountability
• Accountability
• Analytical Problem Solving
• Audit Management
• Change Management
• Chemical Engineering
• Clinical Trials Operations
• Equipment Maintenance
• Equipment Set Up
• GMP Compliance
• Good Manufacturing Practices (GMP)
• Industrial Hygiene
• Machinery Operation
• Machining
• Manufacturing Engineering
• Manufacturing Operations
• Manufacturing Support
• Microsoft Office
• Oracle CRM
• Pharmaceutical Manufacturing
• Pharmaceutical Systems
• Process Optimization
• Production Planning
• Production Scheduling
• Project Management

Nice To Haves

• 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.

Responsibilities

• 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.

Benefits

• The successful candidate will be eligible for annual bonus and long-term incentive, if applicable.
• We offer a comprehensive package of benefits.
• Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 5,001-10,000 employees