Manufacturing Lead Technician - (COAG Bulk)

Role Summary

In general, the Manufacturing Lead Technician is responsible for overseeing the coordination and operations of the production schedule, shift, and personnel. The role involves equipment setup and operation in a biologics processing environment for plasma-derived pharmaceuticals, with strict adherence to FDA regulations and documentation.

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.

Qualifications

• Required: Minimum of 3 years of related experience in a pharmaceutical, GMP, or FDA regulated environment.
• Required: Demonstrated leadership skills with the ability to motivate, guide, train, coach and develop department personnel.
• Required: Comprehensive knowledge and understanding of cGMPs, FDA regulations, and industry guidelines.
• Required: Ability to work independently with minimum supervision.
• 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.
• Preferred: Associate’s degree, applicable certification, and/or military veterans.

Education

• Required: High school diploma or GED.
• Preferred: Associate’s degree, applicable certification, and/or military veterans.

Additional Requirements

• Work is performed in a manufacturing environment with rotating shifts.
• Exposure to biological fluids with potential exposure to infectious organisms.
• Exposure to chemicals, electrical manufacturing equipment, hand tools and moving machinery.
• Exposure to high levels of noise and to extreme cold below 32°F.
• Occasional entry into confined spaces requiring kneeling and squatting.
• Operates forklifts, tractors and power equipment.
• Personal protective equipment required such as protective eyewear, safety shoes, gloves and garments.
• Work is performed standing and walking for 4-6 hours per day.
• Bending and twisting neck and waist for 4-6 hours per day.
• Frequent hand movement of both hands with the ability to make fast, simple, movements of the fingers, hands, and wrists.
• Ability to make precise coordinated movements, of the fingers to grasp and manipulate objects.
• Frequent foot movement.
• Frequent moderate lifting and carrying of 15-44lbs. Frequent heavy lifting and carrying of 45lbs. with a maximum lift of 50lbs.
• Occasionally reaches above and below shoulder height.
• Hearing acuity essential.
• Color perception/discrimination, depth perception and far vision correctable in one eye to 20/30 and to 20/100 in the other eye.
• Able to communicate information and ideas so others will understand; with the ability to listen to and understand information and ideas presented through spoken and written words and sentences.
• Frequently performs simple and routine tasks that vary little each day by following a set of written or oral instructions/procedures.