Packaging Technician II

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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The Packaging Technican II is accountable for driving results in a fast-paced environment by inspecting, labeling and packaging of solid dose and parenteral pharmaceutical products for commercial distribution and clinical trials. The Packaging Technician II will operate inspection and packaging-related processing equipment by following standard operating procedures and batch records in accordance with FDA current Good Manufacturing Practices. The Packaging Technician II will support the Packaging Engineering team by providing critical non-technical and logistical assistance related to equipment qualification, process validation, protocol execution, and daily packaging operations. This role is essential in maintaining project momentum, documentation accuracy, and operational readiness, enabling engineers to focus on core technical responsibilities. The Packaging Technician II employs acceptable techniques while working in manufacturing environments, including PPE gowning. The Packaging Technician II works collaboratively to support other manufacturing areas as required.

100% on-site position.
• 1st Shift: Monday - Friday, 7:30am - 5:30pm.

• 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.
• Performs basic math calculations.
• Operates solid dose inspection, labeling, and packaging equipment.
• Operates material handling equipment.
• Performs in-process checks and component counting.
• Performs cleaning of rooms, tools, and equipment.
• Documents activities in real time on controlled documentation accurately and legibly, per SOPs and cGMPs.
• Assist in preparing and organizing packaging qualification protocols (IQ/OQ/PQ) and reports.
• Support protocol execution on the floor, including sample handling, coordination with operators, and timely data collection.
• Manage and track protocol status, documentation, and related change controls in collaboration with QA and Document Control.
• Schedule and coordinate packaging trials, material availability, and test runs with cross-functional teams.
• Perform basic equipment verifications and checks under engineer guidance.
• Support investigations and deviation documentation by gathering data and formatting summaries.
• Participate in floor walks to monitor execution status and ensure smooth hand-offs during multi-shift validations.
• Maintain packaging technical documentation and assist with updates to SOPs and batch records as needed.
• Provide administrative and coordination support for serialization-related tasks and line readiness check.
• Other duties as assigned.

• High School Diploma or equivalent with 1+ years related work experience. Associates degree preferred.
• Medical device experience or similar experience required.
• cGMP or prior work experience in a regulated environment preferred.
• Prior pharmaceutical or CDMO experience preferred.

• Good verbal and written communication and documentation skills required.
• Good detail orientation and organizational skills required.
• Good problem-solving and basic trouble-shooting ability required.
• Ability to perform basic math calculations.
• Ability to read and comprehend detailed written instructions required.
• Ability to move materials throughout the facility using appropriate methods and equipment required.
• Proficiency in basic computing skills required.
• Awareness of, or prior experience with cGMP practices and procedures preferred.
• Ability to perform basic math calculations, including product accountability calculations and rounding required.

• Less than 5% travel expected.

The physical demands and work environment characteristics described here are representative of those that must be met or encountered by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is regularly required to stand; use hands to finger, handle, or feel; reach with hands and arms; talk or hear and smell. The employee is frequently required to walk; climb or balance and stoop, kneel, crouch, or crawl. The employee is occasionally required to sit. The employee must regularly lift and/or move up to 10 pounds, frequently lift and/or move up to 25 pounds, occasionally lift and/or move up to 50 pounds and occasionally lift and/or move over 50 pounds with assistance. Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision, depth perception and ability to adjust focus.

While performing the duties of this job, the employee is frequently exposed to moving mechanical parts, fumes or airborne particles and toxic or caustic chemicals. The employee is 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. The employee will be required to wear the appropriate personal protective equipment for specific job duties to be performed. Such personal protective equipment may include, but not limited to safety eyewear, hearing protection, various types of respirators/breathing apparatus, lab coats, full protective body coverings, various types of gloves, etc. Other tasks involving elevated work may require the use of a body harness and lanyard. Additionally, the employee may be required to operate an industrial vehicle.