Engineering Manager at Shalina Healthcare

Job Description:

• The Engineering Manager will lead the engineering function within the pharmaceutical manufacturing facility, ensuring reliable equipment performance, compliance with cGMP standards, and efficient execution of maintenance and engineering projects. This role is critical for maintaining uninterrupted production, driving continuous improvement, and supporting regulatory compliance.

Key Responsibilities

Engineering Operations & Maintenance

• Oversee preventive, corrective, and predictive maintenance programs for all manufacturing and utility equipment.
• Ensure equipment qualification and validation (IQ/OQ/PQ) is carried out in line with regulatory and QA requirements.
• Troubleshoot and resolve technical issues that impact production, quality, or safety.

Project Management

• Lead engineering projects, including equipment installation, plant upgrades, capacity expansion, and automation initiatives.
• Develop project scopes, timelines, budgets, and ensure strict adherence.
• Manage vendors, contractors, and OEMs to ensure project deliverables meet quality standards.

Compliance & Regulatory

• Ensure all engineering activities adhere to cGMP, GEP, WHO guidelines, OSHA standards, and applicable pharmaceutical regulations.
• Maintain proper documentation for audits, inspections, and compliance review.
• Support Quality Assurance during internal and external audits (e.g., NAFDAC, FDA, ISO).

Equipment & Facility Management

• Ensure optimal performance of production equipment, HVAC systems, water treatment systems (e.g., purified water, WFI), compressed air systems, and other critical utilities.
• Monitor equipment performance metrics and implement continuous improvement actions.

Leadership & Team Development

• Lead and mentor engineering supervisors, technicians, and maintenance personnel.
• Conduct performance reviews, assign responsibilities, and develop training plans for technical staff.
• Foster a culture of safety, discipline, and engineering excellence.

Continuous Improvement

• Implement strategies for energy optimization, cost reduction, and operational efficiency.
• Drive equipment reliability programs using tools such as root-cause analysis (RCA) and FMEA.
• Collaborate with Production, Quality, HSE, and Supply Chain on improvement initiatives.

Qualifications

Education

• Bachelor’s degree in Mechanical, Electrical, Chemical, or Industrial Engineering.
• Advanced degree or certifications (COREN, PMP, Six Sigma) are an added advantage.

Experience

• 10+ years of engineering experience in pharmaceutical or other regulated manufacturing industries.
• Minimum 5years in a supervisory or managerial role within an engineering/Maintenance department.
• Hands-on experience with pharmaceutical equipment, HVAC, clean rooms, and utilities.

Technical Skills

• Strong knowledge of cGMP requirements.
• Experience with CMMS and engineering documentation systems.
• Proficiency in equipment qualification, validation protocols, and maintenance programs.
• Strong analytical and problem‑solving skills.

Key Competencies

• Leadership & people management
• Project & time management
• Strong communication and collaboration
• Attention to detail and regulatory mindset
• Decision‑making under pressure
• Technical and analytical thinking

Work Environment

• Pharmaceutical production environment with cleanrooms, controlled areas, and strict safety/regulatory standards.
• Requires readiness to respond to emergency breakdowns and critical operations.