Manufacturing Technician II - Sterile Injection - 1st Shift

Manufacturing Technician II - Sterile Injection - 1st Shift

Location

US-NC-Morrisville

ID

2025-1424

Category

Manufacturing

Position Type

Full-Time

Working Hours

1st Shift : Monday - Friday, 7 : 00am - 3 : 30pm

At Alcami, we deliver reliable solutions that unlock the potential of transformative medicines from discovery to commercialization, through trusted partnership with our clients, recognized industry expertise and proven regulatory track record.

Are you interested in joining our team?

Job Summary

The Manufacturing Technician II (Compound / Fill / Finish) is accountable for results in a fast-paced environment and assists with the manufacturing of sterile injectable products in vial and syringe configurations for clinical / commercial distribution. The Manufacturing Tech II is a key role responsible for executing advanced production tasks involving compound, fill and finish processes for sterile injectable pharmaceutical products executed via aseptic isolator technology. This position entails a high level of technical expertise in aseptic processes requiring single-use components, ability to troubleshoot, and responsibility for maintaining quality and compliance with Good Manufacturing Practices (GMP). The Manufacturing Tech. II performs the operation of manufacturing processing equipment by following standard operating procedures (SOPs) and batch records in accordance with regulatory agencies and current Good Manufacturing Practices (cGMPs). The Manufacturing Tech. II employs acceptable techniques while working in manufacturing environments, including PPE gowning. The candidate must have the ability to learn specific department procedures, have a general understanding of Good Documentation Practices (GDP) and GMP, and follow directions from leadership / peers to ensure manufacturing goals are met.

On-Site Expectations

100% on-site position.

• 1st Shift : Monday - Friday, 7 : 00am - 3 : 30pm.

Responsibilities

Manufacturing Technologies for Sterile Liquids (including but may not be limited to) :

Qualifications

Knowledge, Skills, and Abilities

Travel Expectations

Physical Demands and Work Environment

The physical demands and work environment characteristics described here are representative of those that must be met or encountered by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is regularly required to stand; use hands to finger, handle, or feel; reach with hands and arms; talk or hear and smell. The employee is frequently required to walk; climb or balance and stoop, kneel, crouch, or crawl. The employee is occasionally required to sit. The employee must regularly lift and / or move up to 25 pounds, frequently lift and / or move up to 50 pounds, occasionally lift and / or move up to 75 pounds and occasionally lift and / or move over 75 pounds with assistance. Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision, depth perception and ability to adjust focus. The employee must have 20 / 20 vision (with or without corrective lenses) and must possess the ability to pass a color-blind test.

While performing the duties of this job, the employee is frequently exposed to moving mechanical parts, fumes or airborne particles and toxic or caustic chemicals. The employee is occasionally exposed to wet and / or humid conditions; high, precarious places; risk of electrical shock and vibration. The noise level in the work environment is usually moderate. The employee will be required to wear the appropriate personal protective equipment for specific job duties to be performed. Such personal protective equipment may include, but not limited to safety eyewear, hearing protection, various types of respirators / breathing apparatus, lab coats, full protective body coverings, various types of gloves, etc. The use of tight-fitting respirators limits facial hair for proper protection. Based on product, the use of PAPR or supplied air respirator may be required. Regulations may require employees to participate in routine medical surveillance. Other tasks involving elevated work may require the use of a body harness and lanyard. Additionally, the employee may be required to operate an industrial vehicle such as a forklift.