Job Description

The Head of Plant Engineering provides strategic and technical leadership for engineering activities across manufacturing, utilities, facilities, and process systems within Drug Substance (DS) and Drug Product (DP) operations. This role is responsible for engineering governance, asset reliability, lifecycle management, technical standards, and continuous improvement initiatives to ensure operational excellence.

The Head of Plant Engineering leads and develops process engineering teams, oversees resource planning, and drives the execution of departmental goals.

Key responsibilities and minimum requirements according to job level:

· Provides strategic and technical leadership for plant engineering activities across manufacturing,

utilities, facilities interfaces within DS and DP, and process systems for DS & DP.

· Accountable for engineering governance, asset reliability, lifecycle management, technical

standards, and continuous improvement programs for DS & DP.

· Translates business and operational objectives into engineering strategies that improve reliability,

compliance, productivity, and cost effectiveness.

· Leads process engineering teams and develops organizational capabilities.

· Responsible for engineering resource planning, prioritization, budget management, and execution

of departmental objectives.

Competencies required to fulfill the employee responsibilities and work assignments:

· An employee shall follow the job description that pertains to the position. In addition, an

employee shall follow the SOPs that pertains to the position.

· An employee shall adhere to the company policies and procedures that are available on the

Alvotech intranet – Alvocado.

Additional competencies required to fulfill key management responsibilities:

· Responsible for the efficient operation and performance of the Plant Engineering organization

and for ensuring appropriate training, development, and succession planning of team members.

· Fosters the Alvotech culture, promoting collaboration, accountability, innovation, and continuous

improvement across departments.

· Establishes and maintains a high-performance engineering organization through coaching,

mentoring, and employee development.

· Monitors developments and best practices within pharmaceutical and biotechnology engineering

and implements opportunities that improve operational performance and optimize costs.

· Promotes a proactive mindset focused on reliability, technical excellence, compliance, and customer service.

Specifics of the role:

· Leads and manages the Process Engineering organization consisting of

· DSM Upstream Engineer

· DSM Downstream Engineer

· DPM Engineers

· Establishes engineering standards, maintenance philosophies, lifecycle management strategies,

and asset reliability programs for manufacturing systems.

· Ensures reliable operation of upstream, downstream, filling, packaging, process utility, and facility

systems.

· Owns engineering governance processes including change control, deviation support, CAPA

implementation, risk management, and engineering compliance programs for DS &DP.

· Oversees technical investigations related to manufacturing performance, equipment reliability,

process interruptions, and recurring operational issues for DS &DP.

· Drives equipment and process reliability initiatives through root cause analysis, reliability

engineering methodologies, and performance monitoring.

· Provides engineering leadership during commissioning, qualification, validation, and startup

activities.

· Ensures engineering compliance with GMP requirements, regulatory expectations, internal

procedures, and industry standards.

· Collaborates with Manufacturing, Quality, Validation, Automation, MSAT, Supply Chain, and

Facilities teams to ensure seamless operation of manufacturing systems.

· Reviews and approves engineering studies, technical reports, design specifications, impact

assessments, and risk assessments.

· Leads continuous improvement initiatives focused on asset utilization, equipment effectiveness,

energy efficiency, reliability, productivity, and operational excellence.

· Develops and monitors engineering KPIs related to reliability, equipment uptime, maintenance

effectiveness, project execution, compliance, and performance.

· Supports regulatory inspections, customer audits, and internal audits as the engineering subject matter expert for DS & DP.

· Participates in strategic planning and contributes to long-term site engineering and manufacturing capability development.

· Establishes and manages departmental budgets, resource plans, and engineering investment priorities.

· Acts as the senior engineering representative for manufacturing process systems.

· Promotes a culture of safety, quality, compliance, innovation, reliability, and operational excellence throughout the organization

Minimum education and experience required for the role:

· Bachelor's or Master's degree in a relevant engineering discipline.

· Minimum 10 years experience in pharmaceutical, biotechnology, biologics, or regulated manufacturing environments.

· Minimum 5 years leadership experience managing engineering teams.

· Strong GMP, quality systems, reliability engineering, and lifecycle management knowledge.

· Experience supporting capital projects, qualification, commissioning and validation activities.

· Excellent leadership, stakeholder management, organizational and communication skills.