Engineer Manager
About the job
Position Overview
The Engineering Manager is responsible for leading, developing, and coordinating a multidisciplinary engineering team to ensure the safe, compliant, and efficient delivery of engineering projects and maintenance activities in a regulated environment. This role requires a deep understanding of regulatory standards, quality systems, and engineering best practices to maintain product integrity, operational reliability, and regulatory compliance.
Key Responsibilities
Leadership & Team Management
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Lead and mentor a team of engineers, technicians, and support staff, fostering a culture of technical excellence, safety, and continuous improvement.
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Set performance objectives, conduct appraisals, and ensure professional development of team members.
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Allocate resources effectively across projects to meet business objectives and compliance requirements.
Engineering Operations
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Oversee the design, implementation, and maintenance of equipment, systems, and facilities in accordance with engineering and regulatory standards (e.g., GMP, ISO 13485, AS9100, IEC, or equivalent).
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Manage capital projects from concept through commissioning, ensuring scope, cost, and schedule alignment.
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Ensure robust maintenance and calibration programs are in place to guarantee equipment reliability and data integrity.
Regulatory Compliance & Quality
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Ensure engineering activities comply with applicable regulations, quality management systems (QMS), and internal policies.
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Prepare and review technical documentation (URS, design specifications, validation protocols, change controls).
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Support audits and inspections by regulatory bodies and customers.
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Lead risk assessments (FMEA, HAZOP, etc.) and implement mitigation strategies.
Strategic & Continuous Improvement
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Contribute to strategic planning, budgeting, and resource forecasting.
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Drive innovation and process optimization initiatives to improve efficiency, sustainability, and product quality.
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Collaborate cross-functionally with Quality, Manufacturing, R&D, and EHS teams.
Qualifications & Experience
Essential:
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Bachelor's degree in Engineering (Mechanical, Electrical, Chemical, or related discipline).
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Minimum 8-10 years of experience in engineering roles, with at least 3 years in a leadership or management capacity.
- Previous experince in API manufacturing is essential
