Provide overall direction for QMS activity within Engineering function
Ensure uninterrupted engineering services for Production
Design and develop mechanical components and systems for medical devices, equipment, and instrumentation.
Collaborate with interdisciplinary teams, including R&D, manufacturing, quality assurance, and regulatory affairs, to achieve project goals.
Perform engineering calculations, simulations, and testing to validate designs and ensure compliance with industry standards and regulatory requirements.
Participate in design reviews, risk assessments, and technical documentation activities.
Stay updated on emerging technologies, trends, and best practices in mechanical engineering and medical device industry.
Ensure efficient generation and distribution of Utilities such as Electricity, Water, Steam, Water, Compressed Air, Chilled water, Hot water, Cooling water, etc.
Ensure preparation of effective preventative and predictive maintenance programme and ensuring that it is carried out in totality.
Carry out weekly maintenance of equipment as per preventive maintenance plan.
Ensure minimum equipment breakdown for smooth production operations.
Daily, Weekly, Monthly report preparation and submission.
Ensure prompt attendance to alert from all departments and also CAPA implementation for same.
Cost control by root cause analysis of Breakdowns to prevent reoccurrence.
Discipline in the Engineering function.
Training to Staff as per plan and reviewing the same
Bachelor's degree Business Administration, Pharmaceutical Sciences, or related field. Advanced degrees (MBA or related) are highly preferred.
Minimum of 10 to 15 years of senior leadership experience in a manufacturing environment, preferably within pharmaceutical or medical device industries.
Thorough knowledge of cGMP, FDA, EMA, and other relevant regulatory requirements.
Excellent leadership and team management skills, with the ability to motivate, inspire, and develop a diverse team.
Strong strategic thinking, problem-solving, and decision-making abilities.
Ability to make sound decisions under pressure.
Results-driven with a focus on achieving organizational objectives.
Exceptional communication and negotiation skills.
Proven ability to manage budgets, forecast production, and analyze financial data.
Experience in lean manufacturing and continuous improvement methodologies is highly desirable.
Bachelor's degree in business Managment, Pharmaceutical Sciences, or related field. Advanced degrees (MBA or related) are highly preferred.
