Manufacturing Engineer

Manufacturing Engineer

Clinton, TN | Full-time

Experience with automated manufacturing, assembly, packaging, or forming equipment in a Pharmaceutical GMP environment is required for consideration.

About Alcami

Alcami is a contract development and manufacturing organization headquartered in North Carolina with over 40 years of experience advancing products through every stage of the development lifecycle. At Alcami, we are a team of dynamic, agile individuals committed to developing life-saving drugs around the world. A mindset of collaboration, innovation, responsiveness, accountability, and customer focus inspires us to be the most efficient, safe, and reliable choice for our customers and the patients they serve. In return, we offer challenging careers, professional growth, and the opportunity to be part of our skilled team with over 40 years of experience as champions that are dedicated, trustworthy, and relentless to advancing products through every stage of the development cycle.

Summary of the Role:

The Manufacturing Engineer 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 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.

✅ Your Expectations:

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.

Requirements:

• Bachelor’s degree in Engineering or a related technical discipline required.
• Experience with automated assembly, packaging, or forming equipment is 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.

Selection Process:

Submit your Application → Complete a Phone Screening with Alcami’s Recruiter → Complete your Hiring Manager Interview → Complete an Onsite Interview → 15 Minute Site Leader Interview via Teams.

All offers are conditional pending successful completion of Alcami’s pre-employment drug screening, physical examination, and background check.