Job Description

Designation: Instrumentation EngineerLevel: 7-IJob Location: BangaloreThe CompanySyngene International Ltd. (BSE: 539268, NSE: SYNGENE, ISIN: INE398R01022), is an integrated research, development, and manufacturing solutions company serving the global pharmaceutical, biotechnology, nutrition, animal health, consumer goods, and specialty chemical sectors. Syngene's 4500+ scientists offer both the skills and capacity to deliver great science, robust data management and IP security, and quality manufacturing at speed, to improve time-to-market and lower the cost of innovation. With a combination of 1.9 Mn sq ft of specialist discovery, development and manufacturing facilities, as well as dedicated research facilities for Amgen, Baxter, Bristol-Myers Squibb and Herbalife, Syngene works with biotech companies pursuing leading edge science as well as multinationals including GSK and Merck KGaA.Key Result AreasWe are seeking an experienced and dynamic Instrumentation Engineer to manage instrument facilities in our R&D labs. This role will involve installation, repair, maintenance and qualification of equipment to facilitate biologics research and development.Role-specific:

• Accountable for fixing breakdown of Equipment/instrument in lab and get it operational with support from instrument vendor and EAM team.
• Responsible for Equipment Qualification - IQ, OQ, PQ for new instrument installation, including software and hardware, and maintaining the supportive documents in coordination with QA and EAM team.
• Coordinate with the instrument vendor and EAM team to maintain the spares required to avoid breakdown.
• Maintain and circulate preventive maintenance and calibration schedule for the Equipment /instruments in Analytical, Downstream, Upstream, Cell Line Development, Formulation Development labs. Ensure all the equipment preventive maintenance and calibration is completed within the due date.
• Accountable and responsible for Equipment related QMS elements.
• Qualification and requalification of equipment including hardware and software.
• Equipment qualification documentation completion and archival.
• Coordinate with stakeholders and ensure equipment related SOP preparation, risk assessment, approval, and implementation.
• Maintain equipment logbooks, history cards and a list of equipment under AMC.
• Reduce the downtime of the equipment to give trouble-free analysis to end users.
• Maintain Inventory spares parts of Lab equipment in coordination with EAM and vendor. Maintain inventory for the consumables, kits, reagents etc. needed for breakdown, PM, calibration including columns.
• Release of monthly report on breakdown status.
• Follow all the relevant documentation and report preparation about qualification and preventive maintenance as per Syngene policy and procedures.
• PM and calibration data entering in ELN application.
• Participate in SQDECC meeting to understand the problems related to equipment breakdown.
• Provide PTW approval as an area owner.
• SAP approval for PM, breakdown initiation and call closure.
• Weighing Balance daily verification.

Functional Responsibilities:

• Responsible and accountable towards safety and compliance in all the work activities in the own responsibility area(s).
• Monitor and confirm that the established Environment, Occupational Health, Safety and Sustainability (EHSS) practices for safe work environment are followed by self and direct reports.
• Monitor and confirm that self and direct reports adhere to the highest standards of quality, integrity and compliance for every work activity.
• Complete the assigned trainings in a timely manner and comply with the training procedure and training calendar and monitor and confirm the same for the direct reports.
• Attend all assigned mandatory training related to data integrity, health and safety measures, and monitor and confirm the same for the direct reports.
• Participate and support the training on procedures, protocols and On-the-Job activities.
• Comply with Current Good Manufacturing Practices (cGMP) and Good Documentation Practices (GDP).
• Report nonconformities and deviations to the respective supervisor(s) and/or line manager(s).
• Participate and support on-time initiation and closure of deviations, investigations, CAPA and change controls.

Educational Qualification:

• Bachelors or Masters degree in Engineering or Technology or Instrumentation

Technical / Functional Skills:

• 10+ years of experience in managing laboratory instrument facility in pharmaceutical or biopharmaceutical industry.
• Expertise in installation, repair, maintenance and qualification of R&D instruments used in a typical Biopharmaceutical Development Labs.
• Strong technical skills in engineering, repair and maintenance in common laboratory instruments including but not limited to liquid chromatography, mass spectroscopy, capillary electrophoresis, bioreactors, high-throughput screening instruments, filtration systems, etc.
• Experience in eLN is a must and should be well versed in TrackWise QMS Software for raising Deviation, Change Control and CAPA.
• Excellent interpersonal and communications with track record of working in dynamic environment

Equal Opportunity EmployerIt 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 accommodation for qualified individuals with disabilities.Pls visit us a

Syngene International