Engineering – Key Responsibilities, Technical & Soft Skills
Key Responsibilities & Accountability – Handled Individually
- Responsible for planning and execution of greenfield and brownfield projects.
- Ensure projects are completed within the approved budget and timeline, as per GxP standards.
- Lead, mentor, and develop the engineering team, including Managers, Engineers, and Technicians.
- Allocate manpower efficiently to meet operational and project requirements.
- Promote a strong safety culture, conduct risk assessments, and perform safety audits.
- Ensure timely certification of safety-critical equipment.
- Responsible for preparing and controlling annual Engineering budgets (OPEX & CAPEX) in terms of timelines and expenses.
- Responsible for engineering operations, including utilities, production equipment, HVAC, water systems, support utility systems, and facility maintenance.
- Ensure planned preventive maintenance (PPM), breakdown maintenance, and calibration activities are implemented as per approved SOPs, along with proper documentation.
- Review and approve maintenance schedules, work orders, and equipment history records.
- Ensure the availability and reliability of critical equipment to support uninterrupted production.
- Ensure all engineering systems comply with cGMP requirements and internal and regulatory audit standards.
- Ensure complete audit compliance for cGMP, internal, and regulatory audits.
- Ensure proper technical specifications, URS finalization, installation, and commissioning of equipment and systems as per GEP.
- Ensure GxP documentation of qualification, validation, calibration, and re-qualification activities.
Secondary Responsibilities
- Ensure adequate training on GMP, safety, SOPs, and technical skills.
- Ensure overall compliance with GDP and Data Integrity at the workplace.
- Ensure effective implementation of QMS related to engineering systems.
- Ensure compliance with all statutory and legal requirements related to engineering and support all other statutory and legal compliances of the plants.
- Maintain appropriate spare parts inventory and explore alternate vendor development possibilities for machine spare parts and services.
- Manage engineering vendors, contractors, and service providers along with contracts (AMC/CMC) to ensure timely completion of work with the required quality through proper planning.
- Ensure vendor activities comply with GMP, safety, and company procedures.
- Ensure overall implementation of safety work permit systems at the workplace.
- Evaluate vendor performance and maintain approved vendor lists.
- Implement continuous improvement, root cause analysis (RCA), and reliability improvement programs.
Technical Skills Required
- Experienced in CAPEX and OPEX budgeting with effective cost control, along with strong vendor and contractor coordination to ensure timely and cost-efficient project execution.
- Proficient in preventive maintenance (PPM) planning and execution, breakdown maintenance handling, calibration management, maintenance scheduling and work order control, and effective AMC/CMC coordination to ensure maximum equipment reliability and uptime.
- Ability to oversee and maintain complete qualification, validation, and periodic re-qualification documentation in line with regulatory requirements.
- Maintain continuous audit readiness to successfully support internal, customer, and regulatory inspections.
- Ensure strict adherence to Data Integrity principles and Good Documentation Practices (GDP) across all engineering activities.
- Demonstrate strong financial acumen, strategic planning, and resource management skills by effectively managing annual Engineering budgets (OPEX & CAPEX), optimizing costs, and efficiently allocating manpower to drive operational excellence.
Soft Skills Required
- Exhibits strong leadership and people management skills by effectively leading and mentoring engineering managers, engineers, and technicians, fostering talent development, enhancing technical capabilities, and promoting a culture of performance accountability.
- Strong understanding of regulatory expectations and adherence to GMP practices.
- Demonstrates strong strategic thinking and organizational skills by aligning long-term engineering strategies with business objectives, effectively prioritizing projects and operational demands, and optimizing resource allocation and workforce planning.
- Demonstrates strong communication and collaboration skills by effectively coordinating with cross-functional teams, including Production, QA, QC, Regulatory, and EHS, ensuring clear and confident communication during audits and inspections, and maintaining productive relationships with vendors and contractors.
- Exhibits a strong compliance and ethical mindset by taking ownership of audit readiness, ensuring data integrity, and fostering a quality-driven culture.
Technical Skills Required
- Experienced in CAPEX and OPEX budgeting with effective cost control, along with strong vendor and contractor coordination to ensure timely and cost-efficient project execution.
- Proficient in preventive maintenance (PPM) planning and execution, breakdown maintenance handling, calibration management, maintenance scheduling and work order control, and effective AMC/CMC coordination to ensure maximum equipment reliability and uptime.
- Oversee and maintain complete qualification, validation, and periodic re-qualification documentation in line with regulatory requirements.
- Maintain continuous audit readiness to successfully support internal, customer, and regulatory inspections.
- Ensure strict adherence to Data Integrity principles and Good Documentation Practices (GDP) across all engineering activities.
- Demonstrate strong financial acumen, strategic planning, and resource management skills by effectively managing annual Engineering budgets (OPEX & CAPEX), optimizing costs, and efficiently allocating manpower to drive operational excellence.