Senior Mechanical Engineer - Badr Site

Description:

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:

• Project Management:

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.

• Equipment & Utility Management:

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.

• GMP & Compliance:

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.

• Maintenance & Reliability:

Develop preventive and predictive maintenance programs for mechanical equipment.

Lead root cause analysis and implement corrective actions for recurring mechanical issues.

• Process Improvement:

Identify and implement energy-saving, cost-reduction, and performance enhancement opportunities.

Support continuous improvement initiatives in alignment with lean manufacturing principles.

• Documentation & Reporting:

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

Location: EG