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

Merck•Rahway, NJ

1d•Onsite

About The Position

Pharmaceutical Operations and Clinical Supply (POCS) in Rahway, NJ, is seeking highly motivated individuals for R&D Operations roles within their Formulation, Laboratory, and Experimentation (FLEx) Center. This position, a Senior Technician in Operations, specifically supports drug product development and GMP clinical supply of sterile dosage forms as part of the FLEx-Sterile team, focusing on Filling operations. Responsibilities include hands-on processing activities such as sterile filling, lyophilization, and capping, with opportunities for cross-training in thaw, formulation, visual inspection, and sterile supply. The role requires strict adherence to GMP procedures, meticulous attention to detail in documentation, proficiency in electronic systems, and active participation in continuous improvement projects. Technicians may also assist in commissioning, qualification, and demonstration of new equipment. Successful candidates will collaborate with formulators, engineers, Quality, Safety, and Facilities management to ensure the success of the area and clinical pipeline.

Requirements

High School Diploma/GED, with at least 5 years in pharmaceutical manufacturing or processing
OR Associates Degree in Science/Engineering related field with at least 3 years in pharmaceutical manufacturing
OR Bachelors Degree in Engineering Technology or related field
Relevant GMP Pharmaceutical experience, or equivalent (e.g. chemical, nuclear, military experience).
Demonstrated written and verbal communication skills.
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 a part of a team.
Flexibility working overtime is a requirement in manufacturing.
Experience with operating isolator filling machines is required.
Experience in working in Grade A environment is required, including aseptic qualification and performing environmental monitoring.

Nice To Haves

Familiarity with regulatory requirements and Good Documentation Practices (GDP).
Experience with some of the following: highly complex and state of the art equipment, isolators, containment technology, aseptic filling using automated machinery, sterile manufacturing, SAP or other ERP systems.
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.
BioWork Certificate (working in an FDA or similar regulated industry).
Experience with automated systems (MES, SAP, or similar).
Demonstrated troubleshooting / problem-solving skills.
Demonstrated ability to identify and initiate process improvements.
Knowledge of PAS-X is preferable.

Responsibilities

Perform sterile filling operations in compliance with Good Manufacturing Practices (GMP) and Standard Operating Procedures (SOPs).
Work in Grade A environment, including aseptic qualification and performing environmental monitoring.
Operate and maintain large complex isolators, ensuring optimal performance and adherence to safety protocols.
Maintain accurate records of inspection results and maintain accurate records of findings in an electronic system.
Follow established inspection batch records, protocols and quality standards to ensure compliance with industry regulations.
Report any recurring issues or trends to management for further investigation.
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 escalate issues, perform basic troubleshooting, and capturing learnings to improve systems and processes.
Organize and prioritize own work to meet shop floor priorities and identify discrepancies in advance.
Attend and actively participate in safety, quality, and process improvement initiatives to enhance flexibility, efficiency, and compliance.
Understand schedule adherence impact and communicate risk.
Maintain a continuous improvement mindset and implement initiatives to increase efficiency or reduce risk to schedule adherence.
Identify and address compliance, environmental, safety, and process deviations as appropriate while notifying management.
Redline SOPS for continuous improvement.
Support investigations and implementation of corrective/preventative actions.