Manufacturing Technician II (Sterile Injection)

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.

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Job Summary:

The Manufacturing Tech. II employs acceptable techniques while working in manufacturing environments, including PPE gowning. The candidate must have the ability to learn specific department procedures, have a general understanding of Good Documentation Practices (GDP) and GMP, and follow directions from leadership/peers to ensure manufacturing goals are met.

On-Site Expectations:

• 100% on-site position.
• 1st Shift: Monday - Friday, 7:00am - 3:30pm.

Responsibilities:

• Learns and executes manufacturing operations, including setup, operation, and maintenance of equipment used in dispensing, compounding, filling (isolators), and visual inspection.
• Become 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 real-time to support continuous process improvement.
• Maintains accurate and detailed production documentation. Documentation is completed legibly with minimum errors and recommendations are escalated to drive document revisions to reduce errors.
• 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, 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.
• Other duties as assigned.

Manufacturing Technologies for Sterile Liquids (including but may not be limited to):

• 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.)

Qualifications:

• High school diploma or GED is required. Associate or bachelor’s degree preferred.
• 1-2 years’ work experience required; 2-5 years preferred.
• cGMP or prior work experience in a regulated manufacturing environment required.
• Previous experience in dispensing, compounding, aseptic filling, or visual inspection highly desirable.

Knowledge, Skills, and Abilities:

• 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 required.
• Strong problem-solving and basic trouble-shooting ability required.
• 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 handling requirements (i.e. PAPR, Supplied Air Respirator, etc.).
• General compounding equipment (pH meters, mixers, stir plates, rigid/soft vessels)
• Single-use solution pathway parts including aseptic connectors and filtration assemblies
• 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. Ideal candidates must readily adapt to variable operations required batch to batch.
• 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:

Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision, depth perception and ability to adjust focus. The employee must have 20/20 vision (with or without corrective lenses) and must possess the ability to pass a color-blind test.

Additionally, the employee may be required to operate an industrial vehicle such as a forklift.