Operations PREP Technician II

Wilcrest Pharma; Houston (TX); On-site; USD 38,000 - 52,000; Full time

Job summary

JobRx, Inc. in Houston, TX seeks an Operations Prep Technician to support sterile and nonsterile drug compounding and batch manufacturing in a 503B outsourcing facility.

You will prepare equipment, cleanrooms, materials, and chemicals, while following cGMP, GDP, and safety requirements. The role involves maintaining records, supporting traceability, performing startup and closeout tasks, and escalating issues to Operations and Quality.

Qualifications

• High school diploma or equivalent required.
• 1–2 years CGMP/USP or LEAN manufacturing experience required.
• Ability to read and understand batch records, SOPs and controlled forms.
• Familiarity with sterile and nonsterile compounding and aseptic operations preferred.
• Strong attention to detail and documentation accuracy.

Responsibilities

• Prepare, clean, and disinfect materials, components, and equipment used in sterile and nonsterile drug manufacturing.
• Document and maintain accurate inventory and transfer records for materials entering ISO cleanrooms.
• Prepare autoclave loads and support sterilization activities according to procedures.
• Use MasterControl or approved systems to maintain traceability of materials and processes.
• Review and verify cleaning records and production logs in line with Good Documentation Practices.
• Clean and disinfect cleanroom areas per scheduled procedures with production leadership.
• Support material tracking, forecasting, staging, and allocation based on production needs.
• Communicate production needs, shortages, discrepancies, and quality concerns clearly to Operations and Quality.
• Comply with SOPs, cGMP, GDP, aseptic processing expectations, and safety standards.
• Assist with inspection readiness by maintaining clean, organized work areas.
• Perform other duties and assist with special projects as assigned.

Skills

Attention to detail

Reading & following SOPs

Team communication

Basic computer skills

Adaptability in cleanroom

Regulatory compliance mindset

Education

High School Diploma or equivalent

Job description

What We Are Looking For

The Operations Prep Technician supports sterile and nonsterile drug compounding and manufacturing activities within a 503B outsourcing facility. This position is responsible for preparing equipment, cleanroom areas, materials, components, and chemicals for use in batch production while maintaining strict compliance with company SOPs, current Good Manufacturing Practices, Good Documentation Practices, applicable FDA expectations, and quality system requirements. The role performs shift start-up and close-out activities, maintains complete and accurate records, supports material and component traceability, and promptly escalates discrepancies, deviations, equipment concerns, or potential quality events to management and Quality.

What You Will Do

• Prepare, clean, and disinfect materials, components, chemical containers, supplies, and equipment used in sterile and nonsterile drug compounding and batch manufacturing activities within a 503B outsourcing facility.
• Document and maintain accurate inventory and transfer records for materials and components introduced into ISO-classified cleanroom areas.
• Prepare autoclave loads with required components and support sterilization activities in accordance with approved procedures, batch requirements, and quality expectations.
• Use MasterControl software or other approved systems to maintain traceability of components, chemicals, devices, and materials sterilized, transferred, or prepared for production.
• Review, complete, and verify cleaning records, logs, and related production records accurately and in accordance with Good Documentation Practices.
• Clean and disinfect cleanroom areas according to approved daily, weekly, and monthly cleaning procedures in coordination with cleanroom operators and production leadership.
• Support tracking, forecasting, staging, and allocation of materials based on production schedules, batch priorities, historical consumption, and operational demand.
• Communicate production needs, material shortages, discrepancies, and quality-related concerns clearly and promptly to Operations and Quality management.
• Comply with company SOPs, current Good Manufacturing Practices, Good Documentation Practices, aseptic processing expectations, contamination-control practices, quality control requirements, and applicable safety standards.
• Support inspection readiness by maintaining clean, organized, accurately documented, and compliant work areas at all times.
• Perform other related duties as assigned, consistent with the scope and requirements of the position.
• Assist with special projects as needed.

Who You Are

• Education: High School Diploma or equivalent, required
• Experience
  • Previous 1-2 years CGMP/USP or LEAN manufacturing experience, required
• Ability to read, understand, follow, and comply with technical documents, batch records, controlled forms, written instructions, and SOPs.
• Strong attention to detail with the ability to complete production records, cleaning logs, inventory records, and required documentation accurately, legibly, and contemporaneously.
• Working knowledge of sterile and nonsterile compounding, pharmaceutical manufacturing, aseptic operations, cleanroom behavior, contamination control, or regulated production practices preferred.
• Basic understanding of 503B outsourcing facility expectations, cGMP principles, Good Documentation Practices, and quality system requirements preferred.
• Basic computer proficiency, including the ability to use production, inventory, batch record, or traceability systems.
• Ability to communicate professionally and effectively in a team-based manufacturing and quality-driven environment.
• Demonstrated reliability, accountability, and commitment to product quality, patient safety, regulatory compliance, and inspection readiness.
• Ability to follow detailed processing instructions and work consistently in ISO-classified cleanroom and controlled production environments.
• Ability to prioritize tasks, follow production schedules, and respond appropriately to changing operational needs.
• Ability to stand, walk, bend, reach, and perform repetitive tasks for extended periods during assigned shifts.
• Ability to lift, carry, push, or pull up to 40 pounds as needed.
• Ability to wear cleanroom gowning and required personal protective equipment while working in controlled manufacturing environments.
• Experienced with the use of a respirator required.

Equal Opportunity Employer

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