Job Description

JOB DESCRIPTIONJob Title: EAM OU lead (Formulation, OSD, Sterile injectable and Utilities)Job Location: Syngene International Limited, BengaluruAbout Syngene: Syngene ( ) is an innovation-led contract research, development and manufacturing organization offering integrated scientific services from early discovery to commercial supply.At Syngene, safety is at the heart of everything we do personally and professionally. Syngene has placed safety at par with business performance with shared responsibility and accountability, including following safety guidelines, procedures and SOPs, in letter and spiritMandatory expectation for all roles as per Syngene safety guidelines

• Overall adherence to safe practices and procedures of oneself and the teams aligned
• Contributing to development of procedures, practices and systems that ensures safe operations and compliance to company\'s integrity & quality standards
• Driving a corporate culture that promotes environment, health, and safety (EHS) mindset and operational discipline at the workplace at all times.
• Ensuring safety of self, teams and lab/plant by adhering to safety protocols and following environment, health, and safety (EHS) requirements at all times in the workplace.
• Ensure all assigned mandatory trainings related to data integrity, health, and safety measures are completed on time by all members of the team including self
• Compliance to Syngene\' s quality standards at all times
• Hold self and their teams accountable for the achievement of safety goals
• Govern and Review safety metrics from time to time

Core Purpose of the Role:This is an exciting opportunity to play a role of Engineering Lead for formulation and Sterile injectable facility of Syngene. Lot of opportunity to bring new ideas in practices, cost control, simplification, compliance, and safety practices etc. Role to upkeep all engineering system, functionality, tools and ensure uninterrupted business plans.Role Accountabilities

• Responsible for Maintenance of Process, Utility and Facility equipment.
• To ensure all Critical utilities as HVAC & Water Systems are available as per requirement.
• To ensure all other utilities as Power, Compressed Air, Steam and Nitrogen are available as per requirement.
• Adherence to standard operating procedure, safety, cGMP, QMS, & EHSS requirement at Syngene.
• Ensuring safety of self, teams, facility by adhering to safety protocols and following environment, health, and safety (EHS) requirements always in the workplace.
• Manage day to day breakdown calls and ensure the same addressed within agreed SLA.
• Understand the management strategies towards reliable maintenance & Improved way of working and support the shopfloor deployment of same to increase productivity.
• Ensuring availability and utilization of spares, services, and AMCs along with required budget.
• Review and ensuring on time closure of QMS through track-wise (Change Control, CAPA, Deviation)
• Strongly contribute to the investigations part of deviations.
• Ensure zero extension in QMS timelines by having right plan / milestones in place.
• Energy Conservation: Initiation & Implementation of Energy Conservation, Coordination with CFT for Utility operations.
• Handling qualification activities of process / engineering equipment.
• Excellent coordination with CFTs to ensure relevant support extended to achieve common goals.
• Timely escalation of anticipated action / delays and mitigation on improvement activities.
• Plan and execute BCP for all critical equipment controls.
• Periodic report generation on performance/ status on actions / supports needed.
• Work on paperless deployment for all engineering activities in the responsible area.
• Ensure Any Time Audit Readiness.
• Technical and design specs development / review on solutions as needed.
• Able to design and handle upgradation projects.
• Strong in team handling, team development and striving for results

Syngene ValuesAll employees will consistently demonstrate alignment with our core values

• Excellence
• Integrity
• Professionalism

Specific requirements for this role * Experience

• Demonstrated Capability
• Education

Experience

• Experience in pharma process and maintenance.
• 15- 20 years of overall experience and at least 10 -12 years in the related field and exposure (Pharmaceutical / Biotech)
• Expertise in handling of breakdown facility and process equipment maintenance related to Formulation, OSD, Sterile injectable & Utilities.
• Strong maintenance execution of machines like RMG, FBD, FBE, Compression Machines, Capsule Filling, Coating, Process Vessels, Autoclave, Isolator, CIP System, Filling lines, Packaging, BMS, HVAC & Utility equipment.
• Strong presentation and analytical skills. Exposure working with clients / consultants.
• Exposure in handling client and regulatory audits (USFDA/EMA/MHRA etc)
• Hands on experience on Quality systems (Change control, CAPA, Event, Risk assessments)
• Exposure in handling automated system (PLC/SCADA/DCS) and its lifecycle maintenance will be an added advantage.

Skills and Capabilities

• Language preferable- English, kannada, Hindi, Tamil, etc.
• Good understanding & skills in applying Good Engineering Practices and standards (GEP & GxP)
• Presentation skills (Power point, Excel, BI etc).
• Hands on exposure using SAP modules, Track wise, EDMS.
• Exposure in digital tools and adapting them to increase efficiency and compliance.

Education

• Degree in Mechanical / Instrumentation / Electrical or equivalent.

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 accommodations for qualified individuals with disabilities.

Syngene International