Technician, Shared Services Operations - 2nd Shift (Onsite)

Merck; New Jersey; On-site; USD 60,000 - 75,000; Full time

Job summary

Merck in Rahway, NJ seeks hands-on GMP pharmaceutical staff for sterile formulation, aseptic processing, and visual inspection in a Grade C environment. Roles involve assembling sterile equipment, operating sterilization systems, and managing sterile supplies with strict documentation.

Collaboration with formulators, engineers, QA, and facilities is essential to deliver timely clinical production. Ideal candidates have at least 2 years of GMP experience, proficiency with SAP and MS Office, and

Qualifications

• Minimum 2 years of GMP Pharmaceutical experience.
• Proficiency in computer systems including SAP, Microsoft Office, and calibration databases.
• Willingness to lift 50 lbs and perform gowning in cleanroom environments.
• Strong written and verbal communication skills.

Responsibilities

• Assemble sterile equipment per drawings for clinical development and manufacturing.
• Operate cleaning and sterilization equipment including autoclaves and parts washers.
• Receive, inspect, and store sterile supplies ensuring proper inventory levels.
• Prepare and formulate sterile products in Grade A isolator and Grade C environment.
• Perform visual inspections of products and components for defects and non-conformities.
• Maintain meticulous batch records and environmental condition documentation.
• Follow GMP SOPs and support deviations, investigations, and CAPA.
• Collaborate with formulators, engineers, QA, Safety, and Facilities to ensure timely delivery.

Skills

Written and verbal communication

GMP knowledge

Team collaboration

Attention to detail

Documentation

Education

High School Diploma/GED

Tools

SAP

Microsoft Office

Calibration/Maintenance Database

Equipment HMI

PAS-X (preferred)

Job description

Pharmaceutical Operations and Clinical Supply is seeking highly motivated individuals for R&D Operations roles in our Rahway, NJ, Formulation, Laboratory, and Experimentation (FLEx) Center to support drug product development and GMP clinical supply of sterile dosage forms. Positions will support development and clinical manufacturing and supply, as part of the FLEx-Sterile team, specifically in Manufacturing Shared Services which supports sterile supply, aseptic formulation and visual inspection.

This position will be responsible for hands-on processing activities that include equipment assembly and disassembly, sterile processing, inventory management, open aseptic formulation in an isolator and closed formulation activities in a Grade C environment, and manual visual inspection of filled units (i.e. vials or syringes). These individuals are expected to partner with and support formulation development colleagues in further understanding and knowledge capture of processes, which could include providing feedback on product and process development.

These roles require adherence to GMP procedures, strong attention to detail in completing GMP documentation, proficiency in electronic systems, and participation in continuous improvement projects. Positions may also support commissioning, qualification, and demonstration of new equipment and technologies. Successful candidates will collaborate closely with team members and partner groups including formulators, engineers, Quality, Safety, and Facilities management to drive overall success and performance of the area and clinical pipeline.

Key Responsibilities:

• Assembly: Able to read, understand, and follow drawings to assemble sterile equipment to utilize in clinical development and manufacturing processes.
• Sterilization Processes: Operate and maintain cleaning and sterilization equipment, including parts washers, dry heat ovens, and autoclaves.
• Supply Management: Receive, inspect, and store sterile supplies and equipment, ensuring proper inventory levels and organization within the sterile supply area.
• Sterile Formulation: Prepare and formulate sterile products according to established protocols and batch records, ensuring accuracy and compliance with GMP standards. Able to perform closed formulation activities as well as open aseptic activities inside a Grade A isolator. Experience with operating isolator machines and/or Grade A aseptic experience is required.
• Visual Inspection: Perform visual inspections of products and components to identify defects, inconsistencies, and non-conformities. Individual should be detailed and organized, and able to manage a large quantity of units.
• Attention to Detail: Maintain meticulous records of formulation processes, including ingredient quantities, equipment used, and environmental conditions.
• GMP Compliance: Follow all GMP guidelines and standard operating procedures (SOPs) to ensure the quality and safety of clinical production lots. Identifies and addresses compliance, environmental, safety, and process deviations as appropriate while notifying management.
• Batch Adaptability: Quickly adapt to changes in batch procedures and production schedules, demonstrating flexibility and problem-solving skills.
• Cleanroom Environment: Able to gown and work in Grade C conditions, maintaining good aseptic cleanroom behaviors
• Documentation: Maintain accurate records of sterilization processes, inventory levels, and equipment logs in an electronic system. Knowledge of PAS-X is preferable.
• Collaboration: Able to communicate clearly with team and work closely with other teams to ensure on time delivery of supplies.
• Training and Compliance: Assist in training new staff on sterile supply procedures and protocols, ensuring adherence to GMP standards.
• Leadership: Able to identify and escape issues, perform basic troubleshooting, and capturing learnings to improve systems and processes. Also attends and actively participates in safety, quality, and process improvement initiatives to enhance flexibility, efficiency, and compliance.
• Supports investigations and implementation of corrective/preventative actions.

Education Minimum Requirements :

• High School Diploma/GED or higher

Required Experience and Skills :

• Minimum of 2 years of relevant GMP Pharmaceutical experience.
• Demonstrated 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, 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 and communicate both independently and as part of a team.
• Flexibility working overtime is a requirement in manufacturing.

Preferred Experience and Skills :

• At least 2 years GMP manufacturing

Positions are based in Rahway, NJ and 100% on-site.