Filling Set-up Sr. Technician, Operations (2nd Shift) - Onsite

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

Benefits offered by this job

Comprehensive health care insurance

401(k) retirement benefits

Paid holidays and vacation

Job summary

Merck & Co. is seeking a Technician for Operations in Rahway, NJ, focusing on sterile filling set-up in R&D Operations. This role includes hands-on processing in environmentally controlled areas while ensuring adherence to GMP protocols. Ideal candidates are detail-oriented, possess strong communication skills, and are able to troubleshoot complex equipment.

With a salary range of $68,000 to $107,000 based on qualifications, the position offers comprehensive benefits including health care, retirement plans, and paid leave.

Qualifications

• Minimum of 2 years experience as a technician in manufacturing.
• Experience with aseptic filling and GMP protocols.
• Ability to work independently and as part of a team.

Responsibilities

• Conduct sterile filling operations in compliance with GMP.
• Provide hands-on troubleshooting for production equipment.
• Collaborate with Production, Quality, EHS and Engineering teams.

Skills

Hands-on troubleshooting

Attention to detail

Proficiency in computer systems

Communication skills

Education

High School Diploma/GED or higher

Associate's degree in Applied Science or equivalent

Trade certificate or technical diploma in related field

Tools

PLC interfaces

Vision systems

Microsoft Office

SAP

Job description

Job Description

POCS - Rahway: Technician, Operations (FLEx Sterile Filling Set-up Technician)-

There are 2 positions open for this role where the schedule will be 2nd shift (15:30 to 00:00).

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 Filling.

This position will be responsible for hands‑on processing activities that include sterile filling, lyophilization, and capping. Specific tasks include but are not limited to filling line set‑up, executing machinability runs and performing simple adjustments to ensure that the GMP processing runs smoothly. 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

• Ability to provide hands‑on troubleshooting and adjustment for process and production equipment to ensure safe, compliant and reliable manufacturing operations in a cGMP‑regulated environment.
• Work closely with Production, Quality, EHS and Engineering to drive continuous improvement to maximize reliability of manufacturing operations.
• Comfortable with complex, high speed automated systems with mechanical and digital interfaces.
• Familiar with robotic positioning, understanding manual placement utilizing remote pendant to position axis.
• Has experience with vision systems.
• Experience with PLC interfaces and multi‑screen HMIs; experience with automation heavy environments.
• Aseptic Processing
  • Perform sterile filling operations in compliance with Good Manufacturing Practices (GMP) and Standard Operating Procedures (SOPs). Able to perform aseptic interventions within a Grade A Isolator.
  • Operate and maintain large complex isolators, ensuring optimal performance and adherence to safety protocols.
• Sets up, changes over, and test runs equipment for various size containers, stopper, and caps as required. Makes mechanical and electrical adjustments necessary for the correct operation of the equipment.
• Conducts routine microbial and particulate sampling for environmental monitoring.
• Maintain accurate records of inspection results and maintain accurate records of findings in an electronic system. Knowledge of PAS‑X is preferable.
• Follow established inspection batch records, protocols and quality standards to ensure compliance with industry regulations. Able to report any recurring issues or trends to management for further investigation.
• Able to gown and work in Grade C conditions, maintaining good aseptic cleanroom behaviors.
• Communicate clearly with team and work closely with other teams to ensure on time delivery.
• Assist in training new staff on sterile supply procedures and protocols, ensuring adherence to GMP standards.
• Identify and elevate issues, perform basic troubleshooting, and capture learnings to improve systems and processes. Attend and actively participate in safety, quality, and process improvement initiatives.
• Supports investigations and implementation of corrective/preventive actions.
• Overtime is expected for manufacturing support processes.

Education Minimum Requirements

• High School Diploma/GED or higher.
• Successful completion of an associate's degree in Applied Science (A.A.S.) or an equivalent associate degree program or vocational certificate in lieu of the degree program or equivalent military coursework.
• Preferred: Trade certificate, technical diploma, or Associate of Applied Science (A.A.S.) in Mechanical Technology, Electrical Technology, Mechatronics, Instrumentation, or a related field.

Required Experience and Skills

• Minimum of 2 years experience as a technician in a manufacturing, military, automotive, aviation or industrial facility. The experience will include the set‑up changeover, assembly, disassembly, operation and modifications of complex, high speed equipment.
• 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, especially during shutdowns or emergency repairs.

Preferred Experience and Skills

• Experience in regulated manufacturing (pharmaceutical/biotech) under cGMP is strongly preferred.
• Experience in automotive or aerospace is desired.
• Experience with highly complex and state of the art equipment, isolators, containment technology, aseptic filling using automated machinery, sterile manufacturing, visual inspection of product in glass vials, SAP or other ERP systems.
• Associates Degree in science or related field.
• BioWork Certificate (working in an FDA or similar regulated industry).
• Experience with automated systems (MES, SAP, or similar).
• Demonstrated troubleshooting/problem‑solving skills.

Salary

$68,000 - $107,000 (range based on qualifications and experience)

Benefits

We offer a comprehensive package of benefits, including medical, dental, vision, health care insurance for employee and family, retirement benefits (401(k)), paid holidays, vacation, and compassionate and sick days.

Equal Employment Opportunity

As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status or other applicable legally protected characteristics. As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities.