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
-
Lead and mentor a team of engineers, technicians, and support staff, fostering a culture of technical excellence, safety, and continuous improvement.
-
Set performance objectives, conduct appraisals, and ensure professional development of team members.
-
Allocate resources effectively across projects to meet business objectives and compliance requirements.
Engineering Operations
-
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).
-
Manage capital projects from concept through commissioning, ensuring scope, cost, and schedule alignment.
-
Ensure robust maintenance and calibration programs are in place to guarantee equipment reliability and data integrity.
Regulatory Compliance & Quality
-
Ensure engineering activities comply with applicable regulations, quality management systems (QMS), and internal policies.
-
Prepare and review technical documentation (URS, design specifications, validation protocols, change controls).
-
Support audits and inspections by regulatory bodies and customers.
-
Lead risk assessments (FMEA, HAZOP, etc.) and implement mitigation strategies.
Strategic & Continuous Improvement
-
Contribute to strategic planning, budgeting, and resource forecasting.
-
Drive innovation and process optimization initiatives to improve efficiency, sustainability, and product quality.
-
Collaborate cross-functionally with Quality, Manufacturing, R&D, and EHS teams.
Qualifications & Experience
Essential:
-
Bachelor's degree in Engineering (Mechanical, Electrical, Chemical, or related discipline).
-
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
