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

About the role

The 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. 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.

Responsibilities

• Able to read, understand, and follow drawings to assemble sterile equipment to utilize in clinical development and manufacturing processes.
• Operate and maintain cleaning and sterilization equipment, including parts washers, dry heat ovens, and autoclaves.
• Receive, inspect, and store sterile supplies and equipment, ensuring proper inventory levels and organization within the sterile supply area.
• 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.
• Perform visual inspections of products and components to identify defects, inconsistencies, and non-conformities.
• Maintain meticulous records of formulation processes, including ingredient quantities, equipment used, and environmental conditions.
• Follow all GMP guidelines and standard operating procedures (SOPs) to ensure the quality and safety of clinical production lots.
• Identify and address compliance, environmental, safety, and process deviations as appropriate while notifying management.
• Quickly adapt to changes in batch procedures and production schedules, demonstrating flexibility and problem-solving skills.
• Maintain accurate records of sterilization processes, inventory levels, and equipment logs in an electronic system.
• Communicate clearly with team and work closely with other teams to ensure on-time delivery of supplies.
• Absorb and train new staff on sterile supply procedures and protocols, ensuring adherence to GMP standards.
• Identify and escalate issues, perform basic troubleshooting, and capture learnings to improve systems and processes.
• Attend and actively participate in safety, quality, and process improvement initiatives to enhance flexibility, efficiency, and compliance.
• Support investigations and implementation of corrective/preventative actions.

Requirements

• 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.
• Good eyesight to perform detailed inspections.
• Willingness and ability 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.

Qualifications

• High School Diploma/GED or higher.

Skills

• Analytical Thinking.
• Cleanroom Gowning.
• Computer Literacy.
• Equipment Set Up.
• Fabrication Processes.
• GMP Environments.
• GMP Operations.
• Good Manufacturing Practices (GMP).
• In-Process Control (IPC).
• Problem Resolution.
• Production Scheduling.
• Recordkeeping.
• Standard Operating Procedure (SOP) Management.
• Sterile Manufacturing.
• Vaccinations.

Benefits

Comprehensive package of benefits including medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days.

Pay

The Salary Range For This Role Is $52,500 - $82,700. An employee’s position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs.

Schedule

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