Sterile Operations Technician, Shared Services

Merck; Rahway (NJ); On-site; USD 68,000 - 107,000; Full time

Job summary

Merck in Rahway, NJ is seeking a Senior Technician, Operations to support R&D Operations in formulation, aseptic processing, and GMP clinical supply for sterile dosage forms. This on-site role collaborates with formulators, engineers, Quality, Safety, and Facilities to drive manufacturing and clinical material readiness.

You will perform hands-on processing, sterile assembly, cleanroom work, documentation in PAS-X or similar systems, and participate in continuous improvement initiatives.

Qualifications

• GMP pharmaceutical experience or equivalent.
• Strong written and verbal communication skills.
• Proficiency in computer systems and applications including but not limited to: Microsoft Office (Word, Excel and Outlook), Equipment HMI use, MODA, PAS-X, SAP, Calibration/Maintenance Database Systems.
• Must be willing and able to lift 50 lbs, bend, stoop, squat, crawl, twist, climb ladders, and don & wear cleanroom protective gowning including respirators.
• Demonstrated ability to work independently and as part of a team.
• Flexibility working overtime is a requirement in manufacturing.

Responsibilities

• Assembly: read, understand, and follow drawings to assemble sterile equipment for clinical development and manufacturing.
• Sterilization Processes: operate and maintain cleaning and sterilization equipment.
• Supply Management: receive, inspect, and store sterile supplies and equipment.
• Sterile Formulation: prepare and formulate sterile products per protocols and batch records in Grade A isolator.
• Visual Inspection: perform visual inspections of products and components for defects.
• Attention to Detail: maintain meticulous records of formulation processes and conditions.
• GMP Compliance: follow GMP guidelines and SOPs and address deviations as needed.
• Batch Adaptability: adapt to changes in batch procedures and schedules.
• Cleanroom Environment: gown and work in Grade C conditions.
• Documentation: maintain records in an electronic system (PAS-X or similar).
• Collaboration: communicate with team and partner groups to ensure on-time delivery.
• Training and Compliance: assist in training new staff on sterile procedures.
• Leadership: identify issues, troubleshoot, and drive process improvements.
• Schedule Adherence: manage priorities to meet shop floor deadlines.
• Compliance: redline SOPs for continuous improvement.
• Supports investigations and CAPA implementations.

Skills

Biopharmaceutical Manufacturing

Efficiency Improvements

Equipment Operations

GMP

Laboratory Techniques

Manufacturing Quality Control

Pharmaceutical Process Development

Product Inspections

Shift Work

SOP

Education

High School Diploma/GED with 5+ years in pharmaceutical manufacturing

Associates Degree in Science/Engineering related field with 3+ years in pharmaceutical manufacturing

Bachelors Degree in Engineering Technology or related field

Tools

Microsoft Office (Word, Excel, Outlook)

Equipment HMI use

MODA

PAS-X

SAP

Calibration/Maintenance Database Systems

Job description

Merck in Rahway, NJ is seeking a Senior Technician, Operations to support R&D Operations in formulation, aseptic processing, and GMP clinical supply for sterile dosage forms. This on-site role collaborates with formulators, engineers, Quality, Safety, and Facilities to drive manufacturing and clinical material readiness.

You will perform hands-on processing, sterile assembly, cleanroom work, documentation in PAS-X or similar systems, and participate in continuous improvement initiatives.