1st Shift Production Sterilization Specialist

Harrow, Inc.; Ledgewood (NJ); On-site; USD 55,000 - 75,000; Full time

Job summary

Harrow, Inc. is seeking a Production Sterilization Specialist to support commercial manufacturing under ISO7/ISO8 classifications. This role involves operating cleaning machines, preparing supplies, and ensuring aseptic conditions in sterile environments.

A strong emphasis on cGMP, strict PPE, and meticulous documentation is required. The candidate should have 1–3 years in pharma aseptic settings, ability to handle confidential information, and proficient use of MS Office.

Qualifications

• High School Diploma or equivalent; required.
• 1-3 years in pharmaceutical aseptic clean room environments.
• Demonstrated ability to gown into aseptic manufacturing areas.
• Ability to handle sensitive information with confidentiality.
• Able to work in fast-paced environment with strong time management.
• Proficient in Microsoft Office: Excel, Outlook, Word.

Responsibilities

• Ensure compliance with Safety Policies, cGMP, and SOPs.
• Gown and work in sterile areas with proper PPE.
• Report accidents and hazards immediately to management.
• Accurately complete product documentation and logs.

Skills

Aseptic manufacturing experience

Time management

Organizational skills

Gowning & aseptic technique

Confidentiality

Education

High School Diploma or equivalent

Tools

Autoclave

Fedegari

Depyrogentation oven

Job description

Before reading the job post, we encourage you to watch this video about our company. It gives you an inside look at how we started, the team and culture that made us successful, and where we're going. It's easy to read a job post and apply, but people often wonder about the culture and whether they would fit in. If you want to call Harrow your home and genuinely want to be part of a family and something big, then we encourage you to get to know us.

Who is Harrow?

Harrow (Nasdaq: HROW) is a leading provider of ophthalmic disease management solutions in North America. Harrow is an incredible entrepreneurial company – where we celebrate the ability of every member of the Harrow Family to be the CEO of their job. Harrow’s values have driven interest over the past decade in attracting high-performing professionals in a variety of disciplines. Members of our Harrow Family often express their pride in being a part of our commitment to (1) innovation, (2) patient access to affordable medicines, and (3) our track record of having never turned down an ophthalmologist doing mission work around the world – providing free medicines in support of mission work aimed at giving or maintaining the gift of sight to those most in need. We encourage you to learn more about Harrow and its unique culture to see if you’re the right person to help contribute as we build a truly exceptional company, one we are all so proud of!

Harrow’s ophthalmic pharmaceutical portfolio is one of the most comprehensive in the industry, including:

• A broad Dry Eye Disease product line, led by VEVYE ® and bolstered by well-known adjacent ocular surface disease products such as FLAREX ® and FRESHKOTE ®
• A peri-operative Surgical product line, led by TRIESENCE ® , and BYQLOVI TM
• A Rare and Specialty product line, which includes various high-need and utility products such as ILEVRO ® , NATACYN ® , and VERKAZIA ®
• A robust internal development pipeline with multiple late-stage candidates, including MELT-300, MELT-210, H-N08, and CR-01

Job Summary

TheProduction Sterilization Specialistwill be responsible for conducting labeling, packaging, and production support activities to support commercial manufacturing. Under the direction of the Production Supervisor/Team Leader, the Production Support Associate will work hands-on under ISO7, ISO8, and other classified areas with various manufacturing production equipment and technologies. Daily responsibilities vary, including operating cleaning machines and preparing supplies for manufacturing by cleaning and disinfecting.

Core Responsibilities

• Ensures that all work is carried out in compliance with company Safety Policies, current Good Manufacturing Practices (cGMP), and Standard Operating Procedures (SOPs).
• Wears proper personal protective equipment and follows aseptic procedures when gowning, de-gowning, and working in sterile and controlled areas.
• Reports any accidents, incidents, injuries, or illnesses immediately and notifies the manager of any workplace hazards, unsafe acts, or conditions.
• Accurate completion of product documentation and all appropriate logbooks. Maintains cleaning logs per SOP requirements.
• Knowledge of current Good Manufacturing Practices (cGMP) guidelines.
• Excellent organization and time-management skills are required. Must promptly manage a heavy workload and aggressive timelines, prioritize, and work under pressure.
• Cleaning, sanitizing, and disinfection of equipment and components required for production.
• Works with the Warehouse Department to ensure all components are available ahead of time for production.
• Completes all necessary cleaning and sanitizing of production equipment and area.
• Stages material for production use.
• Operation of cleaning equipment including but not limited to Autoclave, Fedegari, and Depyrogentation oven.
• Performs calibration of check weighing.

Qualifications & Requirements

• High School Diploma or equivalent work and education in a related field are required.
• 1-3 years of experience working in the pharmaceutical industry and within aseptic clean room environments.
• Demonstrated ability to successfully gown into aseptic manufacturing areas.
• Ability to handle sensitive information with a high degree of confidentiality.
• Ability to work in a fast-paced environment while demonstrating excellent time management and organization skills.
• Proficient in using standard Microsoft Office software products, including Excel, Outlook, and Word.
• Strong organizational skills with the proven ability to prioritize.
• Works with a sense of urgency while engaging and listening to experts.

Position Type

• On-Site

Travel

• None

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