Technician, Operations (2nd shift) - Oral Solid Dosage / Inhalation

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 oral solid dosage, sterile, and specialty dosage forms. Positions will support development and clinical manufacturing and supply, as part of the Oral Solid Dosage team.

This position will be responsible for hands-on processing activities that include room setup, equipment and material preparation, equipment assembly and disassembly, cleaning, and processing of raw materials into finished drug product.

This evening shift job will focus on spray drying production runs as well as cleaning and turnaround activities for oral solid dosage.

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:

• Prepares, operates, and cleans equipment and facilities used in clinical development and manufacturing processes.

• Operates Spray Drying system for production runs.

• Executes on assembly and disassembly of equipment for process turnaround.

• Maintains, inventories, and transports required processing equipment, materials, supplies, and products.

• Executes all documentation and clerical functions necessary to maintain good manufacturing practice (GMP) operations, using paper-based and electronic systems.

• Maintains detailed knowledge of process equipment and operations. Troubleshoots equipment/systems to resolve issues and aid in technology and process development, capturing learnings to improve systems and processes.

• 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.

Positions are 2nd shift based in Rahway, NJ and 100% on-site. This position will start on days until training is complete, then shift to evening (2nd shift). Occasional day shift assignment weeks may be coordinated throughout the year for continual training purposes.

Education Minimum Requirements: 

• High School Diploma/GED or higher

Required Experience and Skills:

• 1+ years of relevant GMP Pharmaceutical experience, or equivalent (e.g. chemical, nuclear, military 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 …