Apply on Employer Site

Merck · 2 days ago

Associate Specialist, Manufacturing Engineer (Onsite)

Rahway, NJ

Full-time

Onsite

New Grad, Entry Level

$70K/yr - $111K/yr

Merck 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 responsible for compliance and continuous improvement activities within the clinical supply Formulation Laboratory and Experimentation Center, including leading process improvement initiatives and ensuring adherence to Good Manufacturing Practices.

BiotechnologyHealth CareMedicalPharmaceutical

Comp. & Benefits

No H1B

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

Qualification

GMP ComplianceContinuous ImprovementChemical EngineeringPharmaceutical ManufacturingLean / Six SigmaProcess OptimizationMicrosoft OfficeAnalytical Problem SolvingChange ManagementAudit ManagementEquipment MaintenanceManufacturing EngineeringProduction PlanningProject Management

Required

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

Preferred

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