Manufacturing Technician III
Actalent, Morrisville, NC, United States
Job Title: Manufacturing Technician III
The Manufacturing Technician III is responsible for results in a fast‑paced environment, assisting with the manufacturing of sterile injectable products in vial and syringe configurations for clinical and commercial distribution. This role oversees and executes advanced production tasks involving compounding, filling, and finishing of sterile injectable pharmaceutical products using aseptic isolator technology. The technician operates manufacturing processing equipment by following standard operating procedures (SOPs) and batch records, ensuring compliance with regulatory agencies and current Good Manufacturing Practices (cGMP).
Responsibilities
Perform complex manufacturing operations, including setup, operation, and maintenance of equipment used in dispensing, compounding, filling (isolators), and visual inspection.
Serve as a subject matter expert on compounding and filling processes and equipment, providing guidance and training to other manufacturing employees.
Monitor production processes to ensure adherence to SOPs, batch records, and quality standards, making real‑time adjustments to maintain product quality.
Troubleshoot and resolve complex equipment and process issues, minimizing downtime and ensuring efficient production flow.
Conduct in‑process and end‑of‑process sampling and quality checks, ensuring all manufactured products meet rigorous standards.
Collaborate with cross‑functional teams on continuous improvement initiatives to enhance product quality, safety, and efficiency.
Act as an active team member that enacts ideas and incorporates them as part of manufacturing readiness and execution.
Assist with the validation and qualification of new equipment and processes, ensuring seamless integration into the production workflow.
Maintain accurate and detailed production documentation, completing documentation with minimum errors and escalating recommendations for revisions.
Follow applicable SOPs and cGMPs to perform assigned duties and tasks.
Ensure timely completion and compliance with cGMP and all other relevant company training requirements.
Document activities legibly in real time on controlled documentation per SOPs and cGMPs.
Perform in‑process sampling, weight checks, component counting, and basic math calculations.
Perform in‑process inspection and finished product visual inspection.
Clean rooms, tools, and equipment before and after use.
Assist with other manufacturing areas as required.
Perform activities right the first time in areas of material handling, dispensing, compounding, and filling.
Follow general instructions on routine work and detailed instructions on new projects or assignments.
Follow all safety requirements and lead by example a safety‑first culture.
Work occasional hours outside of scheduled shift based on business needs, which may include weekend work.
Essential Skills
4‑6+ years of relevant experience in sterile/aseptic manufacturing or drug substance manufacturing.
Experience in a cGMP pharmaceutical manufacturing environment.
Proven 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 a focus on detail and accuracy.
Excellent verbal and written communication skills.
Ability to execute tasks with minimum oversight while guiding the team.
Strong detail orientation and organizational skills.
Basic computer skills (Microsoft Office) and familiarity with electronic documentation systems.
Additional Skills & Qualifications
High school diploma or GED required; Associate’s or Bachelor’s degree preferred.
Prior pharmaceutical or CDMO experience required.
Ability to read and comprehend detailed written instructions and apply instructions during execution.
Capability 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).
Work Environment
This is a 100% on‑site position. The working hours are on the 3rd Shift, Sunday through Thursday, from 11:00 pm to 7:30 am. The position requires working in a controlled environment with strict adherence to safety and aseptic techniques, including the use of personal protective equipment (PPE).
Job Type & Location
Permanent position based out of Morrisville, NC.
Pay and Benefits
The pay range for this position is $62,400.00 - $79,040.00 per year. Competitive salary, and an exceptional benefits package including medical, dental, vision and prescription coverage, life, LTD, STD, 401(k) with match and immediate vesting, and tuition reimbursement / student loan forgiveness.
Application Deadline
This position is anticipated to close on May 1, 2026.
Equal Opportunity Employer
Actalent is an equal opportunity employer.
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The Manufacturing Technician III is responsible for results in a fast‑paced environment, assisting with the manufacturing of sterile injectable products in vial and syringe configurations for clinical and commercial distribution. This role oversees and executes advanced production tasks involving compounding, filling, and finishing of sterile injectable pharmaceutical products using aseptic isolator technology. The technician operates manufacturing processing equipment by following standard operating procedures (SOPs) and batch records, ensuring compliance with regulatory agencies and current Good Manufacturing Practices (cGMP).
Responsibilities
Perform complex manufacturing operations, including setup, operation, and maintenance of equipment used in dispensing, compounding, filling (isolators), and visual inspection.
Serve as a subject matter expert on compounding and filling processes and equipment, providing guidance and training to other manufacturing employees.
Monitor production processes to ensure adherence to SOPs, batch records, and quality standards, making real‑time adjustments to maintain product quality.
Troubleshoot and resolve complex equipment and process issues, minimizing downtime and ensuring efficient production flow.
Conduct in‑process and end‑of‑process sampling and quality checks, ensuring all manufactured products meet rigorous standards.
Collaborate with cross‑functional teams on continuous improvement initiatives to enhance product quality, safety, and efficiency.
Act as an active team member that enacts ideas and incorporates them as part of manufacturing readiness and execution.
Assist with the validation and qualification of new equipment and processes, ensuring seamless integration into the production workflow.
Maintain accurate and detailed production documentation, completing documentation with minimum errors and escalating recommendations for revisions.
Follow applicable SOPs and cGMPs to perform assigned duties and tasks.
Ensure timely completion and compliance with cGMP and all other relevant company training requirements.
Document activities legibly in real time on controlled documentation per SOPs and cGMPs.
Perform in‑process sampling, weight checks, component counting, and basic math calculations.
Perform in‑process inspection and finished product visual inspection.
Clean rooms, tools, and equipment before and after use.
Assist with other manufacturing areas as required.
Perform activities right the first time in areas of material handling, dispensing, compounding, and filling.
Follow general instructions on routine work and detailed instructions on new projects or assignments.
Follow all safety requirements and lead by example a safety‑first culture.
Work occasional hours outside of scheduled shift based on business needs, which may include weekend work.
Essential Skills
4‑6+ years of relevant experience in sterile/aseptic manufacturing or drug substance manufacturing.
Experience in a cGMP pharmaceutical manufacturing environment.
Proven 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 a focus on detail and accuracy.
Excellent verbal and written communication skills.
Ability to execute tasks with minimum oversight while guiding the team.
Strong detail orientation and organizational skills.
Basic computer skills (Microsoft Office) and familiarity with electronic documentation systems.
Additional Skills & Qualifications
High school diploma or GED required; Associate’s or Bachelor’s degree preferred.
Prior pharmaceutical or CDMO experience required.
Ability to read and comprehend detailed written instructions and apply instructions during execution.
Capability 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).
Work Environment
This is a 100% on‑site position. The working hours are on the 3rd Shift, Sunday through Thursday, from 11:00 pm to 7:30 am. The position requires working in a controlled environment with strict adherence to safety and aseptic techniques, including the use of personal protective equipment (PPE).
Job Type & Location
Permanent position based out of Morrisville, NC.
Pay and Benefits
The pay range for this position is $62,400.00 - $79,040.00 per year. Competitive salary, and an exceptional benefits package including medical, dental, vision and prescription coverage, life, LTD, STD, 401(k) with match and immediate vesting, and tuition reimbursement / student loan forgiveness.
Application Deadline
This position is anticipated to close on May 1, 2026.
Equal Opportunity Employer
Actalent is an equal opportunity employer.
#J-18808-Ljbffr