GMP Engineering Manager at GRIFOLS, S.A.

Cairo, Cairo, Egypt -

Full Time

Start Date

Immediate

Expiry Date

26 Sep, 26

Salary

0.0

Posted On

28 Jun, 26

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

GMP Compliance, Project Management, Engineering Design, Risk Management, Team Leadership, Facility Design, HVAC Systems, WFI Systems, Clean Steam, CAD Software, AutoCAD, SolidWorks, Microsoft Project, Regulatory Adherence, Operational Efficiency, Stakeholder Management

Industry

Pharmaceutical Manufacturing

Description

Job Objective: To lead and manage all engineering activities within the GEPD plant, ensuring full compliance with Good Manufacturing Practices (GMP) and other relevant regulatory standards, while optimizing plant performance, reliability, and operational efficiency through effective team management and strategic project execution. Environment Internal: Interacts extensively with Operations, Quality Assurance, Quality Control, Maintenance, Production, Supply Chain, R&D, and other engineering teams. Collaborates with senior management on strategic initiatives and budget planning. External: Interacts with Engineering Consultancy Office, auditors, regulatory bodies, equipment vendors, engineering service providers, technical office in Grifols S.A., and industry experts. Key responsibility GMP Compliance & Regulatory Adherence: Ensure all engineering design, installation, qualification, and maintenance activities at the GEPD plant strictly adhere to GMP regulations, quality standards, and other relevant local and international regulatory requirements. Project Management: Oversee the planning, execution, and successful completion of engineering projects within the plant, including expansions, upgrades, and new equipment installations, ensuring projects are delivered on time, within budget, and to required quality standards. System Reliability & Optimization: Ensure efficiency, and robustness of plant systems and equipment (e.g., utilities, HVAC, production machinery). Closely monitor the clean area and ensure it meets required specifications. Risk Management: Identify and mitigate engineering-related risks, particularly those impacting product quality, safety, and regulatory compliance. Collaboration & ensuring that equipment complies with the GMP standards. Documentation & Reporting: Ensure meticulous documentation of all engineering activities, specifications, and changes, and prepare comprehensive reports for management and regulatory parties. Academic experience required Bachelor's degree in Chemical, Mechanical, Electrical, or Industrial Engineering. Master's degree in Engineering Management or a related field is highly preferred. Professional Experience Required 5+ years of progressive engineering experience in a regulated manufacturing environment that must be within the pharmaceutical, biotech, or a similarly highly-regulated industry. Extensive expertise in EDA regulations, GMP/GEP guidelines and their practical application in plant operations. Proven experience in managing complex engineering projects from conception to completion. Solid understanding of facility design, utility systems (HVAC, WFI, clean steam), and process equipment in a GMP setting. Computing Skills Proficiency in CAD software (e.g., AutoCAD, SolidWorks). Strong command of Microsoft Office Suite (Excel, Word, PowerPoint, Project). Personal Skills Strong leadership, team management, and mentoring abilities. Excellent analytical, problem-solving, and decision-making skills. Exceptional communication and interpersonal skills, capable of influencing stakeholders at all levels. Results-oriented with a strong focus on quality, safety, and compliance. Ability to manage multiple priorities and work effectively under pressure. Languages Fluent in both written and spoken English. Proficiency in Arabic is highly advantageous for local communication.

Responsibilities

Lead and manage all engineering activities at the GEPD plant to ensure full compliance with GMP and regulatory standards. Oversee project execution, system reliability, and risk mitigation to optimize plant performance and operational efficiency.