Alcami Corporation
Manufacturing Technician III - Sterile Injection - 2nd Shift
Alcami Corporation, Morrisville, North Carolina, United States, 27560
Manufacturing Technician III – Sterile Injection – 2nd Shift
Join Alcami Corporation as a Manufacturing Technician III (Compound/Fill/Finish) responsible for the manufacturing of sterile injectable products in vial and syringe configurations for clinical and commercial distribution. This 100% on‑site role is scheduled for 2nd shift, Monday – Friday, 3:00 pm – 11:30 pm.
Job Summary The Manufacturing Technician III is accountable for advanced production tasks using aseptic isolator technology, ensuring compliance with GMP and maintaining quality standards.
Responsibilities
Performs complex manufacturing operations: setup, operation, and maintenance of dispensing, compounding, filling (isolators), and visual inspection equipment.
Serves as subject matter expert, training and guiding other manufacturing employees.
Monitors production to ensure adherence to SOPs, batch records, and quality standards, making real‑time adjustments.
Troubleshoots and resolves complex equipment and process issues to minimize downtime.
Conducts in‑process and end‑of‑process sampling and quality checks.
Collaborates with cross‑functional teams on continuous improvement initiatives.
Assists with validation and qualification of new equipment and processes.
Maintains accurate production documentation with minimal errors.
Follows applicable SOPs and cGMPs, completing training requirements on time.
Performs in‑process sampling, weight checks, component counting, and basic math calculations.
Performs in‑process inspection and finished product visual inspection.
Conducts room, tool, and equipment cleaning.
Assists with other manufacturing areas as required.
Performs activities with a focus on first‑time quality and safety culture.
Other duties as assigned.
Manufacturing Technologies for Sterile Liquids
Equipment and component preparation and sterilization (filter integrity testing, autoclaving, parts wrapping)
Compounding
Vial washing/depyrgogenation
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, 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
Execute tasks with minimal oversight while providing guidance to teammates.
Excellent verbal and written communication, collaborative team player.
Proven ability to operate, troubleshoot, and maintain complex manufacturing equipment.
Demonstrated leadership, training, and mentoring experience.
Strong analytical and problem‑solving skills with a focus on detail and accuracy.
Applies job skills, company policies, and SOPs to complete tasks.
Strong detail orientation and organizational skills.
Basic problem‑solving and troubleshooting abilities.
Ability to train others effectively.
Basic math calculations.
Ability to read, comprehend, and follow detailed written instructions.
Capacity to move materials throughout the facility using appropriate methods and equipment.
Ability to use appropriate PPE based on product (e.g., PAPR, supplied air respirator).
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 include: standing, hand use, reaching, speaking, hearing, smelling, walking, climbing, balancing, stooping, kneeling, crouching, occasional sitting, and lifting typically up to 50 lb, occasionally up to 75 lb with assistance. Visual demands require 20/20 vision and color‑blind test. Exposure to mechanical parts, fumes, airborne particles, chemicals, wet/humid conditions, high locations, electrical shock, vibration, and moderate noise. Appropriate PPE must be worn. Employees may be required to operate a forklift or use a body harness and lanyard. Medical surveillance may be required per regulations.
Seniority Level Mid‑Senior level
Employment Type Full‑time
Job Function Management and Manufacturing
Industries Pharmaceutical Manufacturing
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Job Summary The Manufacturing Technician III is accountable for advanced production tasks using aseptic isolator technology, ensuring compliance with GMP and maintaining quality standards.
Responsibilities
Performs complex manufacturing operations: setup, operation, and maintenance of dispensing, compounding, filling (isolators), and visual inspection equipment.
Serves as subject matter expert, training and guiding other manufacturing employees.
Monitors production to ensure adherence to SOPs, batch records, and quality standards, making real‑time adjustments.
Troubleshoots and resolves complex equipment and process issues to minimize downtime.
Conducts in‑process and end‑of‑process sampling and quality checks.
Collaborates with cross‑functional teams on continuous improvement initiatives.
Assists with validation and qualification of new equipment and processes.
Maintains accurate production documentation with minimal errors.
Follows applicable SOPs and cGMPs, completing training requirements on time.
Performs in‑process sampling, weight checks, component counting, and basic math calculations.
Performs in‑process inspection and finished product visual inspection.
Conducts room, tool, and equipment cleaning.
Assists with other manufacturing areas as required.
Performs activities with a focus on first‑time quality and safety culture.
Other duties as assigned.
Manufacturing Technologies for Sterile Liquids
Equipment and component preparation and sterilization (filter integrity testing, autoclaving, parts wrapping)
Compounding
Vial washing/depyrgogenation
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, 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
Execute tasks with minimal oversight while providing guidance to teammates.
Excellent verbal and written communication, collaborative team player.
Proven ability to operate, troubleshoot, and maintain complex manufacturing equipment.
Demonstrated leadership, training, and mentoring experience.
Strong analytical and problem‑solving skills with a focus on detail and accuracy.
Applies job skills, company policies, and SOPs to complete tasks.
Strong detail orientation and organizational skills.
Basic problem‑solving and troubleshooting abilities.
Ability to train others effectively.
Basic math calculations.
Ability to read, comprehend, and follow detailed written instructions.
Capacity to move materials throughout the facility using appropriate methods and equipment.
Ability to use appropriate PPE based on product (e.g., PAPR, supplied air respirator).
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 include: standing, hand use, reaching, speaking, hearing, smelling, walking, climbing, balancing, stooping, kneeling, crouching, occasional sitting, and lifting typically up to 50 lb, occasionally up to 75 lb with assistance. Visual demands require 20/20 vision and color‑blind test. Exposure to mechanical parts, fumes, airborne particles, chemicals, wet/humid conditions, high locations, electrical shock, vibration, and moderate noise. Appropriate PPE must be worn. Employees may be required to operate a forklift or use a body harness and lanyard. Medical surveillance may be required per regulations.
Seniority Level Mid‑Senior level
Employment Type Full‑time
Job Function Management and Manufacturing
Industries Pharmaceutical Manufacturing
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