Pharma Packaging Engineering Manager

Alcami; Michigan; On-site; USD 120,000 - 160,000; Full time

Job summary

Alcami is seeking an Engineering Manager to lead engineering, maintenance, and facilities to support compliant pharmaceutical packaging operations. You will oversee reliability, performance, and continuous improvement of production equipment and facility systems, while ensuring safety, quality, and regulatory requirements.

As a member of the site leadership team, you will drive strategic initiatives, manage engineering projects, develop technical talent, and partner cross-functionally to

Qualifications

• Bachelor's degree in Engineering required; Master’s degree preferred.
• Demonstrated mastery of Pharmaceutical cGMP/cGDP principles.
• Significant experience leading engineering, maintenance, technical services, or operations teams in a regulated manufacturing environment.
• 6+ years of relevant experience and 2+ years in management roles.

Responsibilities

• Lead, develop, and mentor engineering, maintenance, validation, and technical services teams.
• Establish and manage comprehensive maintenance programs to maximize equipment reliability and facility performance.
• Drive proactive troubleshooting, root cause analysis, and corrective actions to reduce downtime and improve operational efficiency.
• Collaborate with operations, quality, and technical stakeholders to support business objectives and site performance goals.
• Lead engineering projects from concept through implementation, ensuring delivery on schedule, within budget, and in compliance with quality standards.
• Support specification, installation, startup, qualification, and lifecycle management of manufacturing and packaging systems.
• Utilize data, performance metrics, and industry best practices to identify and implement process improvements.
• Drive continuous improvement initiatives utilizing risk assessments, CAPAs, change controls, and root cause investigations.
• Develop and implement strategies that minimize production interruptions and optimize equipment changeovers.
• Partner with cross-functional teams to improve manufacturing efficiency and long-term equipment performance.
• Align workforce capabilities through effective training and development programs.
• Analyze operational trends and performance data to support strategic decision-making and operational excellence.
• Ensure compliance with cGMP requirements, safety regulations, environmental standards, and internal quality systems.
• Provide oversight for validation lifecycle management, including qualification strategies, risk-based validation approaches, and audit readiness.
• Establish and maintain technical documentation programs that support regulatory compliance and operational effectiveness.
• Lead regulatory inspections, customer audits, and validation-related activities while serving as a technical subject matter expert.

Skills

Engineering leadership

Maintenance management

Root cause analysis

CAPA

Change control

Project management

Regulatory compliance

Communication skills

Education

Bachelor's degree in Engineering

Master's degree preferred

Job description

Alcami is seeking an Engineering Manager to lead engineering, maintenance, and facilities to support compliant pharmaceutical packaging operations. You will oversee reliability, performance, and continuous improvement of production equipment and facility systems, while ensuring safety, quality, and regulatory requirements.

As a member of the site leadership team, you will drive strategic initiatives, manage engineering projects, develop technical talent, and partner cross-functionally to