Process Technician

Job Title:

Process Technician - Filling & Material Preparation

Job Description

The Process Technician supports clinical pharmaceutical manufacturing by preparing materials, operating and maintaining production equipment, and executing aseptic processes in a regulated cleanroom environment. This role works on an 11:00 a.m. to 7:30 p.m. shift and contributes directly to the manufacture of batches for clinical development, ensuring compliance with GMP, GLP, and FDA requirements while helping to optimize production efficiency and product quality.

Responsibilities

+ Manufacture batches by performing complete material preparation and handling activities according to established procedures and quality standards.

+ Operate production equipment used in filling and material preparation, ensuring safe, efficient, and compliant operation.

+ Take ownership of assigned equipment, including routine checks, basic troubleshooting, and coordination of necessary maintenance.

+ Assist in placing orders for materials and consumables and perform material bookings and transactions in SAP.

+ Conduct inventory management activities to ensure adequate stock levels and accurate inventory records.

+ Perform sampling activities according to the defined sampling plan and document results in compliance with regulatory and internal requirements.

+ Prepare and set up format tools and components required for specific production runs and formats.

+ Perform autoclaving of materials and equipment into Grade B cleanroom areas, following aseptic and sterilization procedures.

+ Adjust machinery parameters as needed to maintain process performance, product quality, and regulatory compliance.

+ Collaborate with Plant Engineering to maintain machines and ensure equipment remains in a qualified and reliable state.

+ Support the implementation of production procedures designed to optimize manufacturing processes and meet regulatory requirements.

+ Assist process development teams in developing scalable manufacturing processes that improve product yield and reduce costs.

+ Support maintenance activities on production equipment as needed, following safety and GMP guidelines.

+ Research and help implement new methods, technologies, or process improvements to enhance manufacturing operations.

+ Carry out engineering-related activities associated with production, equipment, or process optimization.

+ Clean, disinfect, and sanitize manufacturing rooms, equipment, and related areas in accordance with cleanroom and GMP standards.

+ Wear and properly use required safety gear and cleanroom gowning while performing duties.

+ Perform physical tasks such as standing, sitting, walking, climbing stairs or ladders, kneeling, and crouching as required by daily operations.

+ Maintain accurate documentation and adhere to GDP (Good Documentation Practice) for all manufacturing and support activities.

Essential Skills

+ Experience working in a pharmaceutical, cleanroom, laboratory, manufacturing, or related technical environment.

+ Knowledge of and adherence to GMP (Good Manufacturing Practice) and GLP (Good Laboratory Practice) standards.

+

Experience with aseptic technique and cleanroom operations, including gowning and behavior in controlled environments.

+ Familiarity with FDA-regulated environments and associated regulatory expectations.

+ Ability to follow and apply GDP (Good Documentation Practice) in all records and documentation.

+ Competence in handling laboratory or manufacturing equipment and performing technical procedures safely and accurately.

+ Ability to operate production machinery and adjust parameters within defined limits.

+ Capability to perform material preparation, including weighing, dispensing, and staging for production.

+ Experience or ability to learn SAP or similar systems for material ordering and booking.

+ Strong attention to detail and ability to follow standard operating procedures and sampling plans.

+ Physical ability to stand, sit, walk, climb stairs or ladders, kneel, and crouch, and to wear safety gear and cleanroom gowning for extended periods.

+ Entry-level chemistry or life science education or equivalent experience in a laboratory or technical setting.

+ Alternatively, at least 2+ years of experience in an FDA/GMP cleanroom or technical setting (BS degree not required).

Additional

Skills & Qualifications

+ Entry-level degree or coursework in Chemistry, Life Sciences, or a related field with hands-on laboratory or technical experience.

+ At least 2+ years of experience in an FDA/GMP cleanroom or technical environment for candidates without a degree.

+ Experience in clinical pharmaceutical manufacturing, quality, or laboratory operations.

+ Hands-on experience with cleanroom procedures and aseptic techniques, including sterilization and autoclaving.

Work Environment

The Process Technician works primarily on-site and splits time between cleanroom production areas and office or support spaces. The position follows an 11:00 a.m. to 7:30 p.m. shift schedule. The facility…