Manufacturing Technician III - Sterile Injection - 12-Hr Day Shift 2-2-3

About the Role

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 is responsible for overseeing and executing advanced production tasks involving compound, fill, and finish processes for sterile injectable pharmaceutical products using aseptic isolator technology. The position requires a high level of technical expertise in aseptic processes, leadership in troubleshooting, and responsibility for maintaining quality and compliance with Good Manufacturing Practices (GMP).

Schedule

100% on-site position. Day Shift: 12-Hour Rotating (2-2-3), 7:00am - 7:00pm.

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) on continuous improvement initiatives to enhance product quality, safety, and efficiency.
• Actively contributes to team performance and manufacturing readiness, often volunteering for tasks and leading by example.
• 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, escalating recommendations to drive document revisions.
• 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, 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.
• Works occasional hours outside of scheduled shift based on business needs, which may include weekend work.
• Other duties as assigned.

Manufacturing Technologies for Sterile Liquids

• Equipment and component preparation and sterilization (e.g., 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.

Skills

• Capable of executing tasks with minimal oversight while guiding the team to ensure manufacturing success.
• Excellent verbal and written communication skills; works collaboratively in a team environment and can stand 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.
• Strong problem-solving and basic trouble-shooting ability.
• Ability to train others effectively.
• Ability to perform basic math calculations.
• Ability to read and comprehend detailed written instructions and apply them during execution.
• Ability to move materials throughout the facility using appropriate methods and equipment.
• Ability to use the 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 and work environment described are representative of those an employee must meet to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform these functions.

• Regularly required to stand; use hands to finger, handle, or feel; reach with hands and arms; talk or hear; and smell.
• Frequently required to walk; climb or balance; and stoop, kneel, crouch, or crawl.
• Occasionally required to sit.
• 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 include close vision, distance vision, color vision, peripheral vision, depth perception, and ability to adjust focus. Must have 20/20 vision (with or without corrective lenses) and pass a color-blind test.
• Frequently exposed to moving mechanical parts, fumes or airborne particles, and toxic or caustic chemicals.
• 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.
• Required to wear appropriate personal protective equipment (PPE), which may include safety eyewear, hearing protection, respirators/breathing apparatus, lab coats, full protective body coverings, gloves, etc. Tight-fitting respirators may limit facial hair for proper protection.
• May be required to participate in routine medical surveillance.
• Other tasks involving elevated work may require the use of a body harness and lanyard.
• May be required to operate an industrial vehicle such as a forklift.