tCognition
Location
Delhi | India
Job description
Job Responsibilities: • Build and manage the maintenance and engineering function in accordance with business requirements. • Work closely for the cGMP facility to carry out the planned preventive maintenance of all equipment aiming to achieve maximum plant availability with a target of zero unplanned downtime. • Conduct and participate in any audits (internal and external) related to QMS and EHS management system in addition to ensuring their smooth execution. • Co-ordination and supervision of all engineering and maintenance personnel including improvement in response times to breakdowns. • Co-ordination of service and planned maintenance of all machinery on site to ensure the safe working of all employees allied to maximizing efficiencies. • Organization and supervision of process engineering personnel to maintain agreed standard service levels and cover for breakdowns over agreed timescales. • Minimization of downtime through machinery efficiencies. • Work with the process development team/ manufacturing team to optimize and scale up biomanufacturing processes for best yields, required key quality attributes and cost effectiveness. • Supervision and monitoring of capital projects. • Oversee risk management activities related to process engineering. • Management, co-ordination, and supervision of all external contractors in accordance with site policies and audit / legal requirements. • Supervision of site maintenance to comply with internal and external audits. • Completion of all necessary paperwork and reports relating to the engineering department as required by senior management. • Assist in the design of the facility and layout of process equipment to optimize the flow of materials and personnel. • Fault finding and repair of machinery following breakdown on a cover/call out basis with minimum disruption to production. • Active participation and attendance at all company health & safety meetings • Other projects and responsibilities, as appropriate in the running of the site. • Work cross-functionally to custom engineer process equipment, as and when required. • Clearly communicate results and recommendations to colleagues and managers.
Expected qualification: • Minimum BE /B tech. in Mechanical or Electronics. • Minimum 10 -12 years hands on experience in biotechnology/pharmaceutical engineering (Preferably Biopharma), guidelines. • Prior 3-5 years exposure to managing and mentoring a small group of experienced employees. • Prior experience with commissioning/ validation activities for biotech process and utility equipment that include FAT/ SAT/ DQ/ IQ/ OQ and PQ programs. • Hands on experience of design and installation of process & utility equipment and appropriate utility requirements. • Knowledge about USP, Schedule M, WHO, ISO 14644, ISO 8573 guideline related to equipment design and qualification, water system, HVAC, compressed air • Hands on experience about water system (pretreatment, purified water system, water for injection system, pure steam), HVAC, clean air. • Prior experience with greenfield project is preferable. • Ability to communicate at all levels, both written and verbal with strong attention to detail • Ability to work under pressure without supervision and meet tight deadlines. • Results, goals, and measurement metrics orientated. • Must be self-motivating, organized, and proactive. • Strong technical aptitude including demonstrated experience in applying scientific reasoning to solve complex problems. • Strong IT skills – competent user of Microsoft Office, Autocad . • Professional attitude and outlook. • Excellent organizational skills. • Drive for continuous improvement. • Be a team player and self-manage.Job tags
Salary
