Manufacturing Operator - 1st Shift

 

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

As a Manufacturing Operator, you are a hands-on, production-oriented team member responsible for operating, maintaining, and troubleshooting packaging equipment to ensure consistent production output. You will play a critical role in minimizing downtime, executing changeovers, and supporting continuous improvement efforts on the production floor. This position requires both mechanical aptitude and operational focus, as you will run equipment while also performing preventative maintenance, resolving issues in real time, and ensuring all activities meet cGMP and safety standards.

On-Site Expectations

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

Responsibilities

Equipment Operation & Maintenance

• Operate packaging equipment to support daily production goals.
• Perform routine inspections, LIGHT preventative maintenance, and minor repairs.
• Troubleshoot basic mechanical issues and resolve problems independently when possible.
• Monitor equipment performance and identify opportunities for improvement.

Changeovers & Production Support

• Execute equipment changeovers including setup, adjustments, and line clearance.
• Perform startup checks and verify equipment readiness after changeovers.
• Troubleshoot production interruptions in real time to minimize downtime.
• Support continuous production flow by maintaining operational readiness.

Inventory & Materials Support

• Communicate spare parts and equipment-related needs to prevent delays.
• Track and document inventory usage and stock levels.
• Support movement of materials and components throughout production.

Documentation & Compliance

• Maintain accurate records of maintenance, repairs, and equipment performance.
• Ensure all work is completed in accordance with cGMP and company procedures.
• Follow documentation practices aligned with cGDP requirements.

Safety & Cleanliness

• Follow all safety standards and company policies.
• Maintain a clean, organized, and hazard-free work environment.
• Promote safe behaviors and proactively address risks.

Team Collaboration & Communication

• Work closely with Production, Quality, and leadership teams.
• Communicate issues, solutions, and updates clearly and timely.
• Contribute to a team-driven environment focused on performance and improvement.

Qualifications

• High School Diploma or GED required.
• Experience operating or maintaining packaging or manufacturing equipment preferred.
• cGMP Certification or one year of experience in a Pharmaceutical GMP Environment is required.

Knowledge, Skills, and Abilities

• Basic mechanical aptitude and troubleshooting ability.
• Strong attention to detail and ability to follow procedures precisely.
• Clear written and verbal communication skills.
• Ability to work independently while contributing to a team environment.

Physical Demands and Work Environment

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 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 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. Based on product, the use of PAPR or supplied air respirator may be required. The use of tight-fitting respirators limits facial hair for proper protection. Regulations may require employees to participate in routine medical surveillance. 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.