Filling Set-up Sr. Technician, Operations - Onsite

Senior Technician, Operations

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.
• Isolator and Filler Operation: 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
• Documentation: Maintain accurate records of inspection results and maintain accurate records of findings in an electronic system. Knowledge of PAS-X is preferable.
• GMP: 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.
• Cleanroom Environment: Able to gown and work in Grade C conditions, maintaining good aseptic cleanroom behaviors
• Collaboration: Able to communicate clearly with team and work closely with other teams to ensure on time delivery.
• Training and Compliance: Assist in training new staff on sterile supply procedures and protocols, ensuring adherence to GMP standards.
• Leadership: Able to identify and escalate 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.
• Overtime is expected for manufacturing support processes.

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

Education Minimum Requirements :

• High School Diploma/GED or higher or
• Successful completion of an associates 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 course work
• 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 year experience as a technician in a manufacturing, military, automotive, aviation or industrial facility is required. 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 a 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 automative or aerospace is desired.
• Experience with some of the following: 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.

The salary range for this role is: $68,000 - $107,000

This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. 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.

The successful candidate will be eligible for annual bonus and long-term incentive, if applicable.

We offer a comprehensive package of benefits.?Available benefits include 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.

Required Skills:

Biopharmaceutical Manufacturing, Clinical Trials Operations, FDA Regulations, GMP Compliance, Good Manufacturing Practices (GMP), Laboratory Techniques, Manufacturing Quality Control, Manufacturing Support, Master Batch Records, Material Selection, Production Planning, Safety Protocols, SAP Enterprise Resource Planning (ERP), SAP Systems, Shift Work, Visual Inspections

Preferred Skills: