Process Operator Dry Room

Job Title:

Process Operator - Dry Room (2nd Shift)

Monday through Friday, from 2:00 p.m. to 10:30 p.m.

Job Description

The Process Operator - Dry Room supports production by operating drying and milling equipment, performing in-process testing, and maintaining accurate documentation in a regulated environment. This role involves working in a dry room with personal protective equipment, handling wet and dry materials, and assisting with related processes such as grinding and basic laboratory testing. The operator follows established standard operating procedures (SOPs) and Good Manufacturing Practice (GMP) guidelines to ensure product quality, safety, and consistency.

Responsibilities

+ Operate equipment in the dry room to remove wet material from dryers and feed it through mills to achieve the required dryness and particle size.

+ Transfer dried powder into 50-gallon drums, securely close, seal, and label each drum according to SOPs and documentation requirements.

+ Perform milling operations to break up material into smaller and finer powder, ensuring consistency with process specifications.

+ Load and unload freeze dryers safely and efficiently, following all operational and safety procedures.

+ Occasionally assist with duties in the Panc area, including grinding, monitoring computer panels, and supporting related production activities.

+ Conduct in-process testing such as pH measurements and basic column chromatography as required to verify product quality.

+ Monitor and operate computer panels and control systems to oversee process parameters and make adjustments within defined limits.

+ Document all production activities accurately, including batch records, process steps, test results, and any deviations, in compliance with GMP standards.

+ Follow all SOPs and quality procedures consistently to maintain regulatory compliance and product integrity.

+ Run finished material tests as needed and record results clearly and completely.

+ Maintain a clean, organized, and safe work area in both the dry room and production office environments.

+ Wear appropriate personal protective equipment (PPE) for extended periods (2-3 hours at a time) while working in the dry room and during material handling tasks.

+ Collaborate with team members to coordinate workflow, support production targets, and assist with cross-functional tasks as needed.

Essential Skills

+ High School Diploma or equivalent.

+ 6 months to 1 year of experience working in a GMP environment.

+ Experience working with standard operating procedures (SOPs) and, ideally, batch records.

+ Ability to follow detailed written and verbal instructions accurately.

+ Comfort working with PPE for extended periods while handling materials and operating equipment.

+ Basic understanding of in-process testing, including pH measurements and simple laboratory techniques.

+ Ability to monitor and interact with computer panels and control systems for production processes.

+ Strong attention to detail for documentation control and record keeping.

+ Capability to perform physical tasks such as moving materials, loading and unloading equipment, and handling drums.

+ Commitment to safety, quality, and adherence to GMP standards.

Additional

Skills & Qualifications

+

Experience with milling, grinding, or similar mechanical processing equipment.

+ Exposure to column chromatography or other basic laboratory processes.

+ Familiarity with documentation control practices in a regulated production environment.

+ Ability to work effectively as part of a small production team.

+ Strong organizational skills to manage multiple tasks such as equipment operation, testing, and documentation.

Work Environment

This role operates primarily in a dry room and production office setting within a GMP-regulated facility. The Process Operator works on second shift, Monday through Friday, from 2:00 p.m. to 10:30 p.m. Time in the dry room requires wearing personal protective equipment (PPE) for 2-3 hours at a time while handling wet and dry materials, operating dryers, mills, and freeze dryers, and filling 50-gallon drums.

Outside the dry room, the operator works in a production office where batch records are…