Manufacturing Engineer - Packaging

 

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 Engineer - Packaging is responsible for the development, optimization, and support of manufacturing processes, tooling, and production equipment within a regulated pharmaceutical packaging environment. This role partners closely with Operations, Technical Services, Quality Assurance, suppliers, and customers to improve manufacturing performance, implement new technologies, and support new product introductions. The Manufacturing Engineer - Packaging drives continuous improvement initiatives, enhances operational efficiency, supports quality systems, and ensures manufacturing processes remain compliant with applicable regulatory and customer requirements. The role also serves as a key contributor to process validation activities, root cause investigations, equipment implementation projects, and long-term operational excellence initiatives.

On-Site Expectations

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

Responsibilities

Process Optimization & Production Support

• Analyze, develop, and implement manufacturing process improvements that enhance quality, efficiency, and overall operational performance.
• Identify opportunities to reduce process variability, improve throughput, and lower manufacturing costs through data-driven decision-making.
• Provide technical support to manufacturing operations to ensure reliable and efficient production performance.
• Partner with cross-functional teams to resolve production challenges and drive sustainable process improvements.

Tooling, Equipment & Engineering Projects

• Lead the introduction, implementation, and commissioning of new tooling and production equipment.
• Coordinate equipment startup activities, technical documentation, training, and operational readiness efforts.
• Collaborate directly with equipment manufacturers and suppliers to establish specifications, address technical concerns, and support long-term equipment performance.
• Support engineering projects through effective project planning, change management, and execution.

New Product Introduction & Operational Readiness

• Support new product implementation activities, including production trials, tooling development, process assessments, and manufacturing readiness planning.
• Coordinate timelines, technical requirements, and validation activities to ensure smooth transitions from project initiation to commercial production.
• Work cross-functionally to identify and mitigate risks associated with new product launches.
• Ensure manufacturing processes and supporting systems are prepared to meet customer and operational requirements.

Quality, Compliance & Continuous Improvement

• Support quality initiatives and collaborate with Quality Assurance to maintain compliance with internal procedures and regulatory requirements.
• Participate in Visual Control Audits (VCA), investigations, and continuous improvement programs.
• Lead or support Root Cause Analysis (RCA), Change Control (CC), Corrective and Preventive Actions (CAPA), Risk Assessments (RA), and validation activities.
• Drive Lean Manufacturing and continuous improvement initiatives that align with business objectives and operational strategies.

Qualifications

• Bachelor’s degree in Engineering or a related technical discipline required.
• Experience with automated assembly, packaging, or forming equipment is required.
• 2+ years of experience of technical support and technical transfer in a pharmaceutical manufacturing environment required.

Knowledge, Skills, and Abilities

• Experience implementing continuous improvement initiatives using Lean Manufacturing methodologies.
• Strong troubleshooting skills with experience conducting root cause investigations and implementing effective corrective actions.
• Experience working in a manufacturing or production environment with cross-functional collaboration across multiple departments.
• Experience managing engineering projects, equipment implementations, process improvements, or change initiatives.
• Pharmaceutical packaging experience or experience within another highly regulated industry is preferred but not required.
• Knowledge of validation, risk management, quality systems, and regulatory compliance principles preferred.
• Strong communication, collaboration, planning, and organizational skills.
• Demonstrated ability to work effectively with customers, suppliers, and internal stakeholders.
• Professional proficiency in English required.

Physical Demands and Work Environment

The physical demands and work environment described here are representative of those that must be met 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 use hands to finger, handle, or feel; reach with hands and arms; talk or hear and smell. The employee is frequently required to sit. The employee is occasionally required to stand; walk and stoop, kneel, crouch, or crawl. The employee must regularly lift and/or move up to 10 pounds, frequently lift and/or move up to 25 pounds and occasionally lift and/or move up to 50 pounds. 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.