Manufacturing Technician II - Sterile Injection - 12-Hr Day Shift 2-2-3
At Alcami, we deliver reliable solutions that unlock the potential of transformative medicines from discovery to commercialization, through trusted partnership with our clients, recognized industry expertise, and proven regulatory track record.
About the role
The Manufacturing Technician II (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 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, troubleshooting, and 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
- Occasional hours outside of scheduled shift based on business needs, which may include weekend work
Responsibilities
- Learns and executes manufacturing operations, including setup, operation, and maintenance of equipment used in dispensing, compounding, filling (isolators), and visual inspection.
- Becomes a subject matter expert (SME) on compounding/filling processes and equipment.
- Performs production processes with adherence to SOPs, batch records, quality standards, and minimally contributes deviations to maintain product quality.
- Conducts in-process and end-of-process sampling/quality checks, ensuring all manufactured products meet rigorous standards.
- Identifies inefficiencies and escalates to area supervision in real-time to support continuous process improvement.
- Maintains accurate and detailed production documentation with minimal errors and escalates recommendations to drive document revisions.
- Ensures timely completion and compliance with cGMP and all other relevant company training requirements.
- Demonstrates technical ability in general manufacturing technologies and utilizes technologies 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.
- 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.)
Requirements
- High school diploma or GED is required; Associate or bachelor’s degree preferred.
- 1-2 years’ work experience required; 2-5 years preferred.
- Prior work experience in a cGMP pharmaceutical manufacturing environment required.
- Previous experience in dispensing, compounding, aseptic filling, or visual inspection highly desirable.
- Candidates with life sciences or engineering degrees will be considered without manufacturing experience.
Skills
- Excellent verbal and written communication skills; works collaboratively in a team environment.
- Proven ability to operate, troubleshoot, and maintain complex manufacturing equipment.
- 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 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 appropriate PPE based on product handling requirements (e.g., PAPR, Supplied Air Respirator).
- Familiarity with general compounding equipment (pH meters, mixers, stir plates, rigid/soft vessels).
- Experience with single-use solution pathway parts including aseptic connectors and filtration assemblies.
- Experience with drug product fillers including isolators.
- Strong attention to detail and the ability to detect minute defects or discrepancies in product appearance.
- Excellent communication and interpersonal skills with the ability to effectively train and certify employees.
- Ability to work independently and collaboratively in a fast-paced environment.
- Flexibility to adapt to changing priorities and support operations at variable capacities.
- Basic computer skills (Microsoft Office) and familiarity with electronic documentation systems is preferred.
Travel Expectations
Up to 5% domestic travel expected.
Physical Demands and Work Environment
- 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 must 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) such as safety eyewear, hearing protection, respirators, lab coats, full protective body coverings, and gloves.
- Use of tight-fitting respirators limits facial hair for proper protection.
- May require 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.