Job Purpose :
The Senior Mechanical Engineer is responsible for leading the design, installation, maintenance, and improvement of mechanical systems and utilities within a pharmaceutical manufacturing facility. This role ensures all mechanical systems comply with industry regulations (GMP, FDA, etc.), support production needs, and contribute to the facility’s safety, reliability, and operational efficiency.
KEY ACCOUNTABILITIES :
Lead mechanical design and execution of CAPEX projects including facility expansions, equipment upgrades, and new installations.
Coordinate with cross-functional teams (Validation, QA, Production, EHS) for seamless project execution.
Design, select, and maintain mechanical equipment such as HVAC, chillers, boilers, AHUs, cleanrooms, and water systems (WFI, RO, PW).
Ensure optimal performance of utility systems supporting cleanroom and manufacturing environments.
Ensure mechanical systems comply with cGMP, FDA, WHO, and local regulatory standards.
Prepare and review qualification documents (DQ, IQ, OQ, PQ) for mechanical systems and equipment.
Develop preventive and predictive maintenance programs for mechanical equipment.
Lead root cause analysis and implement corrective actions for recurring mechanical issues.
Identify and implement energy-saving, cost-reduction, and performance enhancement opportunities.
Support continuous improvement initiatives in alignment with lean manufacturing principles.
Maintain comprehensive records of equipment, maintenance, SOPs, and change controls.
Generate technical reports, project status updates, and compliance documentation.
QUALIFICATIONS, EXPERIENCE, & SKILLS :
QUALIFICATIONS
Bachelor’s degree in Mechanical Engineering
4–6 years of experience in mechanical engineering roles within the pharmaceutical, biotech, or related regulated industries
Strong knowledge of Sterile areas, solid areas and pharmaceutical-grade utilities
Familiarity with regulatory guidelines : cGMP, FDA, ISO, ASME, GEP, and local safety codes
Proficient in AutoCAD or other mechanical design software
Experience with SAP or other maintenance management systems is a plus
EXPERIENCE
Advanced capability in managing & influencing stakeholders
Experience of implementing new initiatives, leading processes and people change, in a complex pan-functional organization, balancing strategic and tactical approaches
SKILLS
Strong leadership and project management skills
Excellent communication and teamwork abilities
Analytical problem-solving and decision-making capability
High attention to detail and commitment to quality and compliance
Mechanical Engineer • Egypt