Engineering Director at Acino International AG in Egypt Lake-Leto, FL

Arcera is a global life sciences company headquartered in Abu Dhabi, United Arab Emirates. Our purpose is to enable longer and healthier lives while creating sustainable growth. We develop, manufacture, and commercialize a broad range of high-quality innovative and proven medicines in key international markets. With an operational footprint spanning over 90 countries across four continents, and manufacturing sites in eight countries, we offer more than 2,000 medicines across various therapeutic areas worldwide.

The Engineering Director is responsible for leading the engineering function at the manufacturing site, ensuring the reliability, safety, and compliance of all facilities, utilities, equipment, and engineering systems. This role sets the strategic direction for engineering, drives continuous improvement, and ensures the site meets global regulatory and business requirements. The position partners closely with Manufacturing, Quality, EHS, Supply Chain, and Global Engineering.

Your responsibilities:

Engineering Leadership & Strategy

• Develop and execute the site engineering strategy aligned with corporate goals and long‑term manufacturing needs.

• Lead a multi‑disciplinary engineering team covering maintenance, utilities, capital projects, automation, and engineering compliance.

• Drive engineering discipline excellence and build organizational capability through coaching, talent development, and succession planning.

Maintenance & Reliability

• Oversee preventive, predictive, and corrective maintenance programs for equipment, production lines, and critical systems.

• Ensure equipment availability and reliability to meet production targets.

• Implement reliability-centred maintenance (RCM) and asset life-cycle management.

Capital Projects & Site Master Planning

• Lead capital investment planning and the execution of engineering projects (expansions, upgrades, new equipment).

• Ensure all projects meet safety, quality, cost, and schedule expectations.

• Own the site’s long-term engineering and utilities master plan.

Engineering Compliance & GMP Standards

• Ensure that all equipment, utilities, and engineering processes comply with GMP, GEP, and regulatory requirements (FDA, EMA, WHO, local authorities).

• Oversee qualification/validation activities (IQ/OQ/PQ) working collaboratively with QA and Validation.

• Ensure full compliance in audits and inspections.

Facilities & Utilities Management

• Oversee the operation and monitoring of all critical utilities including HVAC, clean steam, WFI, compressed air, purified water, chilled water, boilers, and electrical distribution.

• Ensure sustainability, energy efficiency, and optimal cost-to-operate across the site.

• Guarantee business continuity and redundancy of critical systems.

Health, Safety & Environmental Stewardship

• Ensure all engineering activities meet EHS regulations and corporate standards.

• Lead risk assessments (HAZOP, risk matrices, equipment safety).

• Drive engineering contributions to sustainability initiatives and zero-harm culture.

Automation & Digitalization

• Lead automation strategy including DCS, PLC, SCADA, and MES systems.

• Support site digital transformation (Industry 4.0, OT cybersecurity, predictive analytics).

• Ensure data integrity and compliance with 21 CFR Part 11.

Cross‑Functional Collaboration

• Partner with Manufacturing to optimize equipment performance and introduce new technologies.

• Support Quality in investigations, deviations, and CAPA related to engineering and equipment.

• Work with Supply Chain on capacity planning and long‑range production forecasts.

Qualifications and Experience:

• Bachelor’s degree in engineering (Mechanical, Electrical, Chemical, Industrial, Mechatronics, or related).

• Master’s degree in engineering or MBA preferred.

• 15 to 18+ years’ experience in engineering within pharmaceutical or GMP‑regulated industries.

• Proven leadership experience managing large engineering teams.

• Strong background in maintenance, utilities, and capital project management.

• Experience with regulatory inspections (local authorities)

• Strong knowledge of GMP, GEP, validation, and engineering compliance.

• Hands-on experience with automation, utilities, and pharmaceutical production equipment.

• Project Management Professional (PMP) certification is a plus.

• Working knowledge of CMMS systems and reliability tools.

• Excellent communication in English language is a must.

This is the opportunity to join a very dynamic organization, where decisions are taken fast and where you can actively participate in shaping our future. If this sounds exciting, we would love to hear more about you!