Alcami Corporation
Manufacturing Technician III - Sterile Injection - 2nd Shift
Alcami Corporation, Morrisville, North Carolina, United States, 27560
Overview
Manufacturing Technician III - Sterile Injection - 2nd Shift. The Manufacturing Technician III (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. This role involves advanced production tasks for sterile injectable pharmaceutical products using aseptic isolator technology, following GMP/cGMP requirements, SOPs, and batch records. The position requires technical expertise in aseptic processes, gowning, and data/documentation accuracy, with the ability to train and coach other technicians. On-Site Expectations
100% on-site position. 2nd Shift: Monday - Friday, 3:00pm - 11:30pm. Responsibilities
Performs complex manufacturing operations, including setup, operation, and maintenance of equipment used in dispensing, compounding, filling (isolators), and visual inspection. Serves as a subject matter expert (SME) on compounding/filling processes and equipment, providing guidance and training to other manufacturing employees. Monitors production processes to ensure adherence to SOPs, batch records, and quality standards, making real-time adjustments to maintain product quality. Troubleshoots and resolves complex equipment and process issues, minimizing downtime and ensuring efficient production flow. Conducts in-process and end-of-process sampling/quality checks, ensuring all manufactured products meet rigorous standards. Collaborates with cross-functional teams on continuous improvement initiatives to enhance product quality, safety, and efficiency. Acts as an active team member contributing to manufacturing readiness and execution; volunteers and contributes to team performance. Assists with the validation and qualification of new equipment and processes, ensuring seamless integration into the production workflow. Maintains accurate and detailed production documentation, with minimal errors and escalation of recommendations to drive document revisions. Follows applicable SOPs and cGMPs to perform assigned duties and tasks; ensures timely completion and compliance with training requirements. Legibly documents activities in real time on controlled documentation per SOPs and cGMPs. Performs in-process sampling, weight checks, component counting, and basic math calculations; performs in-process inspection and finished product visual inspection. Performs cleaning of rooms, tools and equipment before and after use. Assists with other manufacturing areas as required and follows safety requirements. Performs activities right first time in material handling/dispensing, compounding, and filling. Follows general instructions on routine work and detailed instructions on new projects or assignments. Other duties as assigned. Manufacturing Technologies for Sterile Liquids
Equipment and component preparation and sterilization (filter integrity testing, autoclaving, parts wrapping) Compounding Vial Washing / Depyrogenation Aseptic Filling / Stoppering / Capping Lyophilization Visual Inspection Facility Cleaning/Sanitation Documentation Review (Batch Record, Logbooks, etc.) Qualifications
High school diploma or GED required. Associate’s or Bachelor’s degree preferred. 4-6+ years of relevant experience required, with a strong background in sterile/aseptic manufacturing or Drug Substance manufacturing. Prior work experience in a cGMP pharmaceutical manufacturing environment required. Prior pharmaceutical or CDMO experience required. Knowledge, Skills, and Abilities
Capable of executing tasks with minimum oversight while guiding the team to ensure manufacturing success. Excellent verbal and written communication skills; works collaboratively in a team environment and stands in for Lead during shift exchange. Ability to operate, troubleshoot, and maintain complex manufacturing equipment. Demonstrated leadership skills, with experience training and mentoring team members. Strong analytical and problem-solving skills with attention to detail and accuracy. Applies job skills, company policies and SOPs to complete a variety of assignments. Strong detail orientation and organizational skills. Ability to train others effectively and perform basic math calculations. Ability to read and comprehend detailed written instructions and apply instructions during execution. Ability to move materials throughout the facility using appropriate methods and equipment; ability to use PPE as required (including PAPR/supplied air respirators). Basic computer skills (Microsoft Office) and familiarity with electronic documentation systems. Travel Expectations
Up to 5% domestic travel. Physical Demands and Work Environment
The physical demands and work environment characteristics described are representative of those that must be met to perform essential functions. Reasonable accommodations may be made. The employee is regularly required to stand, use hands, reach, talk, and hear. The employee is frequently required to walk, climb, balance, stoop, kneel, crouch, or crawl. The employee is occasionally required to sit and lift up to 25-75+ pounds with/without assistance. Vision requirements include close, distance, color, peripheral, depth perception, and ability to adjust focus. 20/20 vision (with or without corrective lenses) and color vision may be required. The employee may be exposed to moving mechanical parts, fumes or airborne particles, and chemicals; may be exposed to wet/humid conditions, high places, electrical shock, and vibration. PPE is required and may include respirators. Occasional tasks may involve work at heights or operation of a forklift. Seniority level
Mid-Senior level Employment type
Full-time Job function
Management and Manufacturing Industries
Pharmaceutical Manufacturing Referrals increase your chances of interviewing at Alcami Corporation by 2x. Get notified about new Manufacturing Technician jobs in Morrisville, NC.
#J-18808-Ljbffr
Manufacturing Technician III - Sterile Injection - 2nd Shift. The Manufacturing Technician III (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. This role involves advanced production tasks for sterile injectable pharmaceutical products using aseptic isolator technology, following GMP/cGMP requirements, SOPs, and batch records. The position requires technical expertise in aseptic processes, gowning, and data/documentation accuracy, with the ability to train and coach other technicians. On-Site Expectations
100% on-site position. 2nd Shift: Monday - Friday, 3:00pm - 11:30pm. Responsibilities
Performs complex manufacturing operations, including setup, operation, and maintenance of equipment used in dispensing, compounding, filling (isolators), and visual inspection. Serves as a subject matter expert (SME) on compounding/filling processes and equipment, providing guidance and training to other manufacturing employees. Monitors production processes to ensure adherence to SOPs, batch records, and quality standards, making real-time adjustments to maintain product quality. Troubleshoots and resolves complex equipment and process issues, minimizing downtime and ensuring efficient production flow. Conducts in-process and end-of-process sampling/quality checks, ensuring all manufactured products meet rigorous standards. Collaborates with cross-functional teams on continuous improvement initiatives to enhance product quality, safety, and efficiency. Acts as an active team member contributing to manufacturing readiness and execution; volunteers and contributes to team performance. Assists with the validation and qualification of new equipment and processes, ensuring seamless integration into the production workflow. Maintains accurate and detailed production documentation, with minimal errors and escalation of recommendations to drive document revisions. Follows applicable SOPs and cGMPs to perform assigned duties and tasks; ensures timely completion and compliance with training requirements. Legibly documents activities in real time on controlled documentation per SOPs and cGMPs. Performs in-process sampling, weight checks, component counting, and basic math calculations; performs in-process inspection and finished product visual inspection. Performs cleaning of rooms, tools and equipment before and after use. Assists with other manufacturing areas as required and follows safety requirements. Performs activities right first time in material handling/dispensing, compounding, and filling. Follows general instructions on routine work and detailed instructions on new projects or assignments. Other duties as assigned. Manufacturing Technologies for Sterile Liquids
Equipment and component preparation and sterilization (filter integrity testing, autoclaving, parts wrapping) Compounding Vial Washing / Depyrogenation Aseptic Filling / Stoppering / Capping Lyophilization Visual Inspection Facility Cleaning/Sanitation Documentation Review (Batch Record, Logbooks, etc.) Qualifications
High school diploma or GED required. Associate’s or Bachelor’s degree preferred. 4-6+ years of relevant experience required, with a strong background in sterile/aseptic manufacturing or Drug Substance manufacturing. Prior work experience in a cGMP pharmaceutical manufacturing environment required. Prior pharmaceutical or CDMO experience required. Knowledge, Skills, and Abilities
Capable of executing tasks with minimum oversight while guiding the team to ensure manufacturing success. Excellent verbal and written communication skills; works collaboratively in a team environment and stands in for Lead during shift exchange. Ability to operate, troubleshoot, and maintain complex manufacturing equipment. Demonstrated leadership skills, with experience training and mentoring team members. Strong analytical and problem-solving skills with attention to detail and accuracy. Applies job skills, company policies and SOPs to complete a variety of assignments. Strong detail orientation and organizational skills. Ability to train others effectively and perform basic math calculations. Ability to read and comprehend detailed written instructions and apply instructions during execution. Ability to move materials throughout the facility using appropriate methods and equipment; ability to use PPE as required (including PAPR/supplied air respirators). Basic computer skills (Microsoft Office) and familiarity with electronic documentation systems. Travel Expectations
Up to 5% domestic travel. Physical Demands and Work Environment
The physical demands and work environment characteristics described are representative of those that must be met to perform essential functions. Reasonable accommodations may be made. The employee is regularly required to stand, use hands, reach, talk, and hear. The employee is frequently required to walk, climb, balance, stoop, kneel, crouch, or crawl. The employee is occasionally required to sit and lift up to 25-75+ pounds with/without assistance. Vision requirements include close, distance, color, peripheral, depth perception, and ability to adjust focus. 20/20 vision (with or without corrective lenses) and color vision may be required. The employee may be exposed to moving mechanical parts, fumes or airborne particles, and chemicals; may be exposed to wet/humid conditions, high places, electrical shock, and vibration. PPE is required and may include respirators. Occasional tasks may involve work at heights or operation of a forklift. Seniority level
Mid-Senior level Employment type
Full-time Job function
Management and Manufacturing Industries
Pharmaceutical Manufacturing Referrals increase your chances of interviewing at Alcami Corporation by 2x. Get notified about new Manufacturing Technician jobs in Morrisville, NC.
#J-18808-Ljbffr