Manufacturing Lead Technician - IGIV Bulk
About The Position
In general, the Manufacturing Lead Technician is responsible for overseeing the coordination and operations of the production schedule, shift, and personnel. This role involves working in a biologics processing environment for plasma-derived pharmaceuticals, with a strong emphasis on adhering to FDA regulations, documentation practices, and safety policies. The position requires performing facility and equipment cleaning, basic process analysis, and operating manufacturing equipment such as ultrafiltration units, chromatography columns, Clean In Place (CIP) systems, Steam In Place (SIP) systems, and centrifuges. The technician will also utilize touch screen Operator Interface Terminals (OIT), train entry-level personnel, perform advanced job tasks, and assist management in coordinating daily operations, serving as a leader in the absence of direct supervision.
Requirements
- High school diploma or GED required.
- Minimum of 3 years of related experience in a pharmaceutical, GMP, or FDA regulated environment is required.
- Demonstrated leadership skills with the ability to motivate, guide, train, coach and develop department personnel.
- Comprehensive knowledge and understanding of cGMPs, FDA regulations, and industry guidelines.
- Ability to work independently with minimum supervision.
- Must be proactive, results oriented, and have strong attention to detail.
- Self-starter with strong work ethic and the ability to exercise good judgment.
- Ability to effectively prioritize and manage multiple tasks to meet targeted deadlines.
- Strong interpersonal skills with the ability to interact with personnel at all levels in a team environment.
- Must be able to read, write, and speak English.
- Computer literacy with proficiency in MS Office (Outlook, Word, Excel, PowerPoint).
- Must be flexible with working hours / shifts in order to accommodate the 24-hour, 7 day plant operation.
Nice To Haves
- Associate’s degree, applicable certification, and/or military veterans preferred.
Responsibilities
- Responsible for equipment 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 basic process analysis such as pH, refractive index, turbidity, and conductivity measurements.
- Operates manufacturing equipment such as ultrafiltration (UF) units, chromatography columns, Clean In Place (CIP) systems, Steam In Place (SIP) systems and centrifuges.
- Utilizes touch screen Operator Interface Terminals (OIT).
- Trains entry level personnel.
- Performs more complex and advanced job tasks.
- Assist management in coordinating and scheduling the department's day to day operations.
- Serves in a leadership role in the absence of direct supervision.
- Other duties may be assigned.
Benefits
- Medical
- Dental
- Vision
- PTO
- up to 5% 401(K) match
- tuition reimbursement
- life insurance
- paid holidays
- company bonus pool
Stand Out From the Crowd
Upload your resume and get instant feedback on how well it matches this job.
What This Job Offers
Job Type
Full-time
Career Level
Entry Level
Education Level
High school or GED
