Lead Manufacturing Technician – Fill Finish
Website iBio, Inc.
Just imagine what we can do together! We know great things happen when talent and opportunity cross paths. We are looking to hire exceptional people who have demonstrated track records of success. Our greatest scientific solution is bringing talented people together who have a passion for advancing plant-based biologics for our customers and the world.
Apply now for our Lead Manufacturing Technician – Fill Finish position!
MISSION OF THE POSITION
Based in Bryan, Texas, this position will perform basic to complex activities on the fill finish line for production and will work in accordance with regulations, detailed protocols, batch records, SOPs, and work instructions. The Lead Manufacturing Technician – Fill Finish will be expected to be a subject matter expertise cGMP manufacturing.
The Lead Manufacturing Technician focus will be to provide operational and technical support for all fill finish operations with adherence to cGMP compliance. This position requires proficiency in aseptic technique, and deliberate movements inside isolators. The candidate for this position will be working in close association with Process Development, Quality Assurance, Quality Control, Project Management, and Supply Chain to ensure conformance to the manufacturing schedule.
Essential Duties & Responsibilites
- Daily Aseptic processing within a controlled isolator environment and within a BSC.
- Perform legible, clear, and concise data entry into batch records, logbooks, and all other controlled forms used in a cGMP process.
- Follows verbal and written procedures in operating production equipment and performing processing steps.
- Identifies, escalates and documents events and variances that deviate from normal operation; participate as needed in investigations.
- Monitor assigned processes using automated production systems and controls with limited supervision.
- Equipment preparation activities including, parts cleaning, autoclaving, and room clearance.
- Demonstrates ability to troubleshoot basic mechanical operations.
- Post-Fill tasks will include visual inspection, secondary packaging, and environmental monitoring.
- Performs batch record review, procedure revisions, and work order generation.
- Fulfills role of lead trainer on numerous operations and is an area SME.
- Work in accordance with site and company EHS programs.
- Prepare and process components, materials and equipment for aseptic fill finish activities, operate filling equipment and perform aseptic manipulations, able to inspect finished vials and perform labeling activities to support shipment.
Knowledge, Skills, & Abilities
- A strong attention to detail
- Must be able to work in a fast-paced environment.
- Team Player
- Excellent verbal and written communication skills
- Ability to aseptically gown and/or sterile gown as needed.
- Effectively utilizes Microsoft office applications.
- Work towards solutions to given problems and operate under cGMP requirements.
- Work cross-functionally with support groups such as Facilities, Supply Chain, Quality Control and Quality Assurance.
- Qualify to work in aseptic environments to complete required production activities.
Education & Experience
- BS – Chemistry, Biology or related field – preferred. A combination of education and experience will be considered.
- 3+ years industry related experience of on-the-floor leadership or “subject matter expertise”.
- Subject matter expertise in cGMP manufacturing.
To apply for this job please visit www.linkedin.com.