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.

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

• 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.

• 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.

• 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.

• 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.

• 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.

• 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.

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…