Executive - Plant Maintenance (Biologics)

Job Description

Designation: Executive Plant Maintenance (Biologics)Job Location: BangaloreDepartment: Engineering and MaintenanceAbout Syngene Incorporated in 1993, Syngene International Ltd. is an innovation-focused global discovery, development and manufacturing organization providing integrated scientific services to the pharmaceutical, biotechnology, nutrition, animal health, consumer goods and specialty chemical industries around the world. Syngene s clientele includes world leaders such as Bristol-Myers Squibb, Baxter, Amgen, GSK, Merck KGaA and Herbalife. Its innovative culture is driven by the passion of its 4240- strong team of scientists who work with clients from around the world to solve their scientific problems, improve R&D productivity, speed up time to market and lower the cost of innovation.Job Purpose: This role will be responsible for Maintenance and continuous enhancement of Plant maintenance in Biologics Syngene. Upgrade and maintain existing installations. Execute enhancement programs like enterprise asset management Quality Management System along with Maintenance of Biologics Manufacturing Plant.Key Responsibilities: Planning and undertaking scheduled maintenance for Plant equipment, qualification, and clean area maintenance and periodic validation. Shall respond immediately to stoppage of operations due to breakdown or other reasons and turn around at earliest. Should handle the documentation related to events / incidents within the quality framework. Should write / change SOPs to standardize maintenance work practices. Oversee the project activities as and when required by coordinating with project team for building new facilities. Shall work on spares management ensuring timely availability of required accessories. Shall drive execution on various digitization and safety enhancement initiatives in the manufacturing area. Shall create PR requisitions in SAP for spares procurement and follow up and ensuring spares availability. Shall comply to safety standards of Syngene. Shall be able to handle qualification and requalification activity as per cGMP requirements Possess the knowledge and exposure to environment, health, and safety (EHS) practices Follow environment, health, and safety (EHS) requirements at all times in the workplace ensuring individual and lab/plant safetyEducational Qualification: Engineering Graduate in Mechanical / Electrical from Institute of repute Degree/Diploma in Management - optional Certification in lean management / six sigma will be an added advantageTechnical/functional Skills: Should be well versed with Plant maintenance aspects of Biologics drug substance manufacturing and within the framework of Quality Management System for a GMP Life Sciences facility with Clean area manufacturing. Should have hands on experience on Plant equipment like Bioreactors, Fermenters, automation in process, CIP/SIP, autoclave, downstream filtration, centrifuges, TFF, cold storages, clean area maintenance. Should be technically thorough on control logic automation Should be well versed with QMS framework in digital environment, change management, deviation, report writing, equipment qualification, area validation etc. working closely with the team from Quality Assurance. Should be hands-on in SAP for raising purchase requests, getting the required spares stocked by working closely with Sourcing team. Willing to work in Shifts.Experience: 2 to 5 years of similar experience Exposure to Life Sciences manufacturing is necessaryBehavioral Skills: Adherence to safe practices, commitment to integrity and quality. Should be an excellent communicator in English with listening, speaking, reading and writing skills.Equal Opportunity Employer: It is the policy of Syngene to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by applicable legislation or local law. In addition, Syngene will provide reasonable accommodations for qualified individuals with disabilities.,

Keyskills :
report writingquality management systementerprise asset managementcontinuous improvement facilitationpilot projectsequal employment opportunityanimal healthsix sigmaconsumer goodslife sciencescontrol logic