Impel Talent is leading the search for a key engineering role on behalf of our confidential client—an independent, family-owned international group of companies dedicated to manufacturing in the pharmaceutical industry. With a presence in Asia, Europe, and North America, and a team of over 2,000 professionals, our client is at the forefront of innovation, delivering excellence for clients, partners, and patients worldwide.
About the Role:
This role is crucial in ensuring the assembly, qualification, and automation of facilities, equipment, and utility systems in compliance with cGMPs, FDA regulations, and industry best practices. You will be a key contributor to continuous improvement initiatives, enhancing operational efficiency, reliability, and compliance.
Key Responsibilities:
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Ensure cGMP and HSE requirements are integrated into engineering solutions.
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Review engineering designs to incorporate regulatory and technical requirements.
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Lead construction, assembly, commissioning, and qualification of engineering projects.
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Develop and maintain installation plans and manage project resources effectively.
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Address technical challenges while maintaining design integrity and process functionality.
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Oversee compliance with change control processes and ensure proper authorization for scope changes.
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Conduct inspections and tests in line with project standards and regulatory requirements.
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Manage commissioning and qualification activities, ensuring user and technical requirements are met.
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Investigate deviations, implement corrective actions, and support regulatory audits.
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Facilitate knowledge transfer and training for end-users.
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Maintain compliance with safety, environmental, and regulatory guidelines.
Candidate Profile:
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Degree in Engineering (Mechanical, Electrical, Electronics/Automation, Civil) or related scientific field (mandatory).
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Proven experience in installation management or equipment qualification, preferably in chemical or pharmaceutical environments.
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Knowledge of GMP, HSE, and regulatory frameworks for technical installations.
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Familiarity with quality guidelines, including cGxPs, ICH, ISPE, and ISO.
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Strong problem-solving, project management, and stakeholder communication skills.
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Ability to respond to audits and regulatory inspections.
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Proficiency in English (written and verbal).
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Skilled in MS Office and CAD software.
Why Join Our Client?
Our client values people as their most valuable asset. They foster an inclusive and diverse work environment where individuals are respected and supported in achieving their full potential. As a proud Equal Opportunity Employer, they welcome applications from candidates of all backgrounds.
This is a confidential search process. For more details or to express interest, please contact Impel Talent directly.
