Assembly Engineering Manager

Assembly Engineering Manager

Hovione

Loures, Portugal

You will be responsible to:

The Assembly Engineering Manager leads assembly, commissioning, and qualification activities for facilities, utility systems, and process equipment at the Sete Casas site. Responsible for the full lifecycle of assigned capital projects - from early design through GMP-compliant handover - this role combines strong technical ownership with people leadership and operational discipline.

Reporting to the Senior Manager, Engineering & Maintenance, and operating within Hovione's Engineering Transformation Programme, the role works cross-functionally with Process, Quality, HSE, and Automation to deliver projects on time, on budget, and to the highest cGMP standards.

Leadership & Team Management

• Lead, coach, and develop team members, covering recruitment, onboarding, training, and performance management in line with company HR policies;
• Translate business objectives into clear departmental and individual goals, ensuring alignment and accountability across the team;
• Foster a high-performance culture aligned with Hovione values, sustaining team engagement and motivation;
• Conduct performance reviews, define individual development plans, and manage underperformance in collaboration with HR;
• Identify high-potential employees and actively support succession planning and career progression.

Operational Excellence & Delivery

• Plan, manage, and execute engineering and maintenance activities following asset lifecycle management principles;
• Develop and implement annual master plans encompassing budget, resource allocation, and success metrics;
• Ensure delivery of all area KPIs; continuously monitor performance and drive corrective action where needed;
• Drive continuous improvement by identifying inefficiencies, challenging current practices, and increasing productivity;
• Manage outsourced contractors and service providers to meet site quality, safety, and schedule requirements;
• Report weekly on project progress, pending items, and deadlines; escalate relevant deviations promptly.

Assembly, Commissioning & Qualification

• Lead the execution of assembly, commissioning, and qualification phases (DQ/IQ/OQ/PQ) for assigned capital projects;
• Ensure cGMP and HSE requirements are incorporated into URS and design specifications from early project phases;
• Develop and maintain detailed installation plans with clear visibility on criticality, dependencies, and milestones;
• Identify and implement technical solutions for unexpected challenges during construction and commissioning without compromising design intent or process functionality;
• Participate in, issue, review, and/or approve C&Q documentation (Protocols, Test Datasheets, Instrument Impact Assessments, Reports);
• Coordinate commissioning and qualification activities with Design Engineering, Automation, QC, QAU, and user areas;
• Lead external qualification contractors, ensuring optimal use of their time and cost;
• Guarantee that all facilities are handed over fully commissioned and qualified, meeting user requirements and cGMP guidelines;
• Maintain punch lists with accountable owners and deadlines, ensuring ongoing cGMP and HSE compliance.

Technical & Compliance Oversight

• Ensure equipment and processes comply with all applicable local, national, and industry regulations (FDA, EMEA, ICH, ISPE, ISO);
• Guarantee adherence to GMP requirements and Hovione internal standards (SOPs, COPs, HBR, etc.);
• Promote and maintain a strong EHS culture across all engineering activities and teams;
• Execute change control assessments per defined standards; ensure proper authorisation is obtained prior to any scope change or additional work;
• Execute deviation investigations and implement CAPAs in accordance with applicable procedures;
• Define technical competency requirements for the team and implement structured training plans;
• Participate in client and health authority audits within the scope of Qualification and Validation.

Budget & Resource Management

• Own and monitor departmental budgets; track deviations and implement timely corrective actions;
• Optimise resource allocation — internal and external — to meet operational, project, and financial targets;
• Ensure all assigned tasks are planned and delivered on time, safely, efficiently, and cost-effectively.

We are looking to recruit a Candidate:

Education & Experience

• Degree in Engineering — Mechanical, Electrical, Electronic, Instrumentation, Civil, or related field (mandatory);
• Proven track record in industrial engineering or maintenance environments, preferably in pharmaceutical, chemical, or food & beverage industries;
• Demonstrated experience leading and developing engineering teams in project or operational contexts;
• Solid knowledge of cGMP, HSE practices, and applicable regulatory requirements (FDA/EMEA) — strongly desirable;
• Familiarity with ICH, ISPE, and ISO guidelines applicable to pharmaceutical technical installations;
• Experience with capital project management (planning, cost control, reporting) — valued.

Skills & Competencies

• Strong leadership with the ability to inspire, develop, and hold teams accountable;
• Solid command of engineering principles, technical regulations, and industry standards;
• Excellent communication skills — clear, direct, and effective at all organisational levels;
• Strong organisational skills with the ability to manage multiple priorities in a dynamic environment;
• Structured approach to process management, continuous improvement, and performance tracking;
• Results-driven mindset with a consistent track record of delivering on targets;
• Proficient in MS Office; knowledge of project management tools and CAD software is a plus;
• Fluent in English — mandatory; Portuguese is an advantage.