Role Summary
The Manufacturing Technician - IGIV Bulk is part of the team responsible for converting human plasma to injectable protein therapies. The technician sets up, operates, and cleans process equipment used to separate, purify, fill, inspect, and package Grifols protein products. Location: Los Angeles, CA. This role requires adherence to FDA regulations and cleanroom procedures to ensure product quality and safety.
Responsibilities
- Responsible for equipment cleaning, setup and operation in a biologics processing environment for plasma derived pharmaceuticals.
- Strict adherence to procedures and practices according to FDA regulations.
- Strong emphasis on documentation according to FDA regulations.
- Adhere to departmental corporate safety policies.
- Responsible for facility and equipment cleaning.
- All work is performed in a clean room (sanitized) manufacturing environment.
- Responsible for performing the following daily tasks: cleaning/sanitizing aseptic and non-aseptic processing areas, preparing and sterilizing filling and freeze-drying components (such as vials, stoppers, and filling assemblies), and performing aseptic fills.
- May be trained in the freeze drying (Lyophilization) process.
- Utilizes touch screen Operator Interface Terminals (OIT).
Qualifications
- Required: High school diploma or GED required.
- Preferred: Associate’s degree, applicable certification and/or military veterans.
- Required: Must be proactive, results oriented, and have strong attention to detail.
- Required: Self-starter with strong work ethic and the ability to exercise good judgment.
- Required: Ability to effectively prioritize and manage multiple tasks to meet targeted deadlines.
- Required: Strong interpersonal skills with the ability to interact with personnel at all levels in a team environment.
- Required: Must be able to read, write, and speak English.
- Required: Computer literacy with proficiency in MS Office (Outlook, Word, Excel, PowerPoint).
- Required: Must be flexible with working hours / shifts in order to accommodate the 24 hour, 7 day plant operation.
Skills
- Attention to detail and strong documentation practices.
- Self-motivation and ability to work independently and as part of a team.
- Ability to prioritize and manage multiple tasks to meet deadlines.
- Good interpersonal skills and ability to interact with personnel at all levels.
- English reading/writing proficiency; strong communication skills.
- Computer literacy and proficiency with MS Office suite.
- Ability to follow procedures in a regulated, cleanroom environment.
Education
- High school diploma or GED required.
- Associate’s degree or applicable certification preferred.
Additional Requirements
- Occupational Demands: Work in a manufacturing/warehouse environment with rotating shifts; exposure to biological fluids, chemicals, and moving equipment; use of PPE; heavy lifting up to 75 lbs; standing/walking 4-6 hours per day; frequent hand/finger movements; vision requirements; and other physical requirements as described.
- Shifts: Swing, Graveyard, Weekend Grave, Weekend Day (as offered).