Manufacturing Operator I

Manufacturing Operator I

JOB-10045618

Anticipated Start Date

January 12, 2026

Location

Irving, TX

Type of Employment

Contract-to-Hire

Employer Info

Our client is a leading biopharmaceutical company specializing in innovative cellular and biologic products that address unmet clinical needs and improve patient outcomes. With decades of experience in human perinatal biologics, both domestically and internationally, the organization is at the forefront of biotechnology innovation.

Joining the team offers the opportunity to be part of a dynamic and rapidly growing company dedicated to advancing science and developing technologies that make a lasting global impact.

Qualifications:

• High school diploma or equivalent required. Associate or bachelor’s degree in biotechnology, Biology, Biochemistry, or a related field preferred.
• Basic computer proficiency (MS Office – Word, Excel and Outlook)
• Good communication skills and the ability to work both autonomously and within a team environment.
• Ability to read, understand, and follow detailed written instructions and procedures accurately.
• Basic knowledge of cleanroom protocols, contamination control principles, and quality standards (e.g., ISO, GMP) is a plus; on-the-job training will be provided.
• Ability to safely and successfully perform the essential job functions consistent with the ADA, FMLA and other federal, state and local standards, including meeting qualitative and/or quantitative productivity standards.
• Ability to maintain regular, punctual attendance consistent with the ADA, FMLA and other federal, state and local standards
• Physical stamina and the ability to perform tasks involving standing, bending, lifting up to 10 pounds consistently (up to 50 lbs occasionally), and wearing required PPE for extended periods.

Description :

• Perform related duties as assigned by Laboratory Director.
• Maintain compliance with all company policies and procedures.
• Responsible for keeping confidential all company documentation, work product, controlled documents, SOP’s, specification sheets, and company intellectual property.

Quality System

• Be familiar with applicable regulations and standards described in the Quality Manual.
• Maintain good documentation practices.
• Report any deviation from procedure in a timely manner.
• Participate in the annual Internal Audit procedure.
• Accurately complete electronic batch records and paperwork daily prior to sending it to Quality Assurance for review ensuring adherence to Good Documentation Practices.

Cleanroom Sanitization

• Wear appropriate Personal Protective Equipment (PPE), including cleanroom suits/coveralls, hoods, masks, goggles, gloves, and shoe covers, following multi-stage gowning and de-gowning procedures.
• Perform routine and deep cleaning/disinfection of ceilings, walls, floors, surfaces, and production equipment within ISO 7 and ISO 8 classified cleanrooms.
• Responsible for controlled area cleaning –pre/post clean.
• Operate and maintain specialized cleaning equipment, such as HEPA-filtered vacuum systems and relevant cleaning tools.
• Manage waste disposal, including hazardous materials, following established protocols and regulatory guidelines.
• Maintain accurate and detailed documentation of all cleaning activities, monitoring results, and any incidents in logbooks or electronic systems.
• Maintain inventory of cleaning chemicals, garments, and supplies, and ensure the proper storage and maintenance of cleaning equipment.
• Collaborate with cross-functional teams to support production schedules and resolve any cleanroom-related issues.

Aseptic Processing

• Strictly adhere to proper gowning procedures and aseptic techniques when working in controlled environments to prevent contamination.
• Assists manufacturing processes in a cleanroom environment according to the established procedures.
• Operate and maintain manufacturing equipment such as biosafety cabinets, incubators, centrifuges, and bioreactors. Perform the cleaning and preventive maintenance of designated equipment.
• Assist in preparing reagents, consumables and raw materials for manufacturing.
• Assist with environmental monitoring and maintain a clean and organized workspace.
• Assist with any issues related to consumables, disposables and reagents.