Engineering Manager📍 Clinton, TN | Full-timeExperience leading engineering, maintenance, and technical teams in a pharmaceutical GMP regulated manufacturing environment is required for consideration.📝 Summary of the Role:The Engineering Manager is responsible for leading engineering, maintenance, and facilities, functions to support compliant pharmaceutical packaging operations. This role oversees the reliability, performance, and continuous improvement of production equipment, facility systems, and engineering programs while ensuring adherence to safety, quality, and regulatory requirements. As a member of the site leadership team, the Engineering Manager drives strategic initiatives, manages engineering projects, develops technical talent, and partners cross-functionally to optimize operational performance, minimize downtime, and support business growth. The position also provides oversight of validation strategy, technical documentation programs, facility maintenance, and capital projects while ensuring inspection readiness and regulatory compliance across all engineering-related activities.
• Your Expectations:Engineering Leadership & Maintenance Excellence- Lead, develop, and mentor engineering, maintenance, validation, and technical services teams.
- Establish and manage comprehensive maintenance programs that 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.
Engineering Projects & Continuous Improvement- 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.
Operational Readiness & Technical Strategy- 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.
Compliance, Validation & Documentation Management- 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.
🎓 Requirements:- Bachelor's degree in Engineering is required; Master's degree preferred.
- Demonstrated mastery of Pharmaceutical cGMP/cGDP principles is required.
- Significant experience leading engineering, maintenance, technical services, or operations teams within a regulated manufacturing environment.
- Experience with automated manufacturing, assembly, packaging, or forming equipment required; pharmaceutical packaging experience is preferred.
- Strong knowledge of mechanical, electrical, facilities, and manufacturing systems.
- Demonstrated experience managing engineering projects, equipment installations, startup activities, and qualification efforts.
- Proven leadership skills with the ability to develop teams, drive engagement, and support employee growth and development.
- Strong understanding of continuous improvement methodologies, including Root Cause Analysis (RCA), Change Control, CAPA, Risk Assessments, and validation principles.
- Excellent communication, presentation, stakeholder management, and relationship-building skills.
- Demonstrated ability to work effectively in a fast-paced environment, prioritize competing demands, and drive strategic initiatives.
- Strong analytical and problem-solving skills with a continuous improvement mindset.
- Full 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
