Manufacturing Technician III - Sterile Injection - 2nd Shift

Alcami Corporation•Morrisville, NC

16d•Onsite

About The Position

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. The Manufacturing Technician III is a key role responsible for overseeing and 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, leadership in troubleshooting, and responsibility for maintaining quality and compliance with Good Manufacturing Practices (GMP). The Manufacturing Technician III 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 Technician III employs acceptable techniques while working in manufacturing environments, including PPE gowning. The Manufacturing Technician III demonstrates technical ability in applicable functional areas including department procedures, troubleshooting/problem solving, manufacturing document revision, and training/coaching other technicians. The position requires the ability to convey new processes and techniques to other team members to support the manufacturing department.

Requirements

High school diploma or GED required.
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.
Capable of executing tasks with minimum oversight while giving guidance to 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.
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.
Applies job skills, company policies and SOPs to complete a variety of assignments.
Strong detail orientation and organizational skills required.
Strong problem-solving and basic trouble-shooting ability required.
Ability to train others effectively.
Ability to perform basic math calculations.
Ability to read and comprehend detailed written instructions and apply instructions during execution is required.
Ability to move materials throughout the facility using appropriate methods and equipment required.
Ability to use the appropriate PPE based on product (i.e. PAPR, Supplied Air Respirator).
Basic computer skills (Microsoft Office) and familiarity with electronic documentation systems is required.

Nice To Haves

Associate’s or Bachelor’s degree preferred.

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 (e.g., Manufacturing Specialists, Technical Services, Quality Assurance, Engineering, etc.) on continuous improvement initiatives to enhance product quality, safety, and efficiency.
Is an active team member that enacts ideas and incorporates them as part of manufacturing readiness and execution.
Employee is first to volunteer and largely contributes to performance of the team.
Assists with the validation and qualification of new equipment and processes, ensuring seamless integration into the production workflow.
Maintains accurate and detailed production documentation. Documentation is completed with minimum errors and recommendations are escalated to drive document revisions to reduce errors.
Follows applicable SOPs and cGMPs to perform assigned duties and tasks.
Ensures timely completion and compliance with cGMP and all other relevant company training requirements.
Legibly documents activities in real time on controlled documentation per SOPs and cGMPs.
Performs in-process sampling, weight checks, and 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.
Performs activities right first time in areas of material handling/dispensing, compounding, and filling.
Follows general instructions on routine work and detailed instructions on new projects or assignments.
Follows all Safety requirements and leads by example a safety-first culture.
Assists with other manufacturing areas as required.
Other duties as assigned.
Equipment and component preparation and sterilization (i.e., 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.)