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Sterilization Manager

Flexi Careers
Location: Aurangabad, Experience: 10 years - 17 years
Posted On: 30-Oct-2021 | Last Date to Apply: 28-Jan-2022 | No: of Vacancies : 1 | CTC: 30 to 35 Lacs

Company Profile:

Avtar enables high growth organizations to focus sharply on effective and sustainable talent strategies to make the workplace more inclusive Avtar has helped MNCs and Large Indian Conglomerates to structure and implement sustainable Diversity Inclusion programs

Job description:

Prepares capital expenditure proposals starting from preparation of draft proposals, vendor selection, price negotiations, planning, and execution. Leads projects end-to-end.
Lead engineering projects, New Technology or Technology Transfer projects to improve existing technology with respect to Quality, Compliance, Capacity and Cost. Ensure that projects are completed on time and within budget with no impact to quality or customer service. Develop and execute detailed project plans using standard project management tools (charter, Gantt chart, etc.). Prepare/review capital & expense forecasts for assigned projects. Prepare capital authorization requests (CAR).
Sterilization: Under limited supervision & general direction and in accordance with all applicable federal, state and local laws/ regulations and Corporate Johnson & Johnson, procedures and guidelines, this position:
Prioritize, assign and coordinate for EO & Gamma sterilization, UDI, serialization and related work.
Establish, review and communicate plans (work/project scope, cost, schedule, resource requirements, and risks) for sterilization related activities required to meet system demands and business objectives.
Lead & prepare a sterilization road map and prepare a strategy to implement them. Support in preparing technology road map and prepare a strategy to implement them.
Lead the various sterilization related projects in tandem with WW sterilization experts.
Lead & deliver projects like sterilizer replacement, new cycle creation, existing cycle improvement (as needed) and new practices development.
Monitor progress to ensure final deliverable meet lifecycle boundaries and customer acceptance criteria.
Engage to comply with ISO and local FDA requirements. Responsible for revision I creation of documents like SOP, Forms etc required for manufacturing /Sterilization/UDI/Serialization & as required.
Ensure and comply with EO & GAMMA Sterilization process requirements.
Ensure to comply the Annual re-certification of Ethylene Oxide sterilization process and GAMMA process is as per ISO 11135 and ISO 11137 requirements.
Accountable for eliminating significant quality issues due to Sterilizer. Ensure compliance to the Quality system requirements. Utilize Problem solving skills and statistical techniques to support product I processes controls that are aligned with the overall quality and business vision.
Signing, writing and approving of protocols, IQ, OQ & PQ documents and validation strategy.
Projects : Report status on assigned projects in formats adequate to different organizational levels.
Ensure machine design complying to J&J safety guidelines including all OSHA and J &J Machine Guarding requirements.
Follow the Ethicon change control process for all applicable projects.
 Perform process validations on new, transferred, or modified processes.
Understand the product and process structure (BOMs, Routes, DMR, etc.)
Propose project ideas through analysis of existing processes and equipment with the intent of achieving continuous improvement, including the business case assessment.
Leads project teams effectively with internal and external resources from Quality Engineering, Procurement, Global Supply Chain, Finance, Manufacturing (OPS) and suppliers.
Develops and maintains a network of suppliers and partners.
Perform technical assessments and develop validation strategies and understand the impact on E2E supply chain.
Lead engineering projects, New Technology or Technology Transfer projects to improve existing technology with respect to Quality, Compliance, Capacity and Cost. Ensure that projects are completed on time and within budget with no negative impact to quality or customer service.
Manage the NCR and CAPA process by documenting, investigating, root cause analysis, and implementing corrective actions for product non-conformances.
 Ensure effective use of engineering and quality systems and adherence to quality system regulations (QSR).
Ensure compliance to the quality policy in all activities.
Support and promote the safety and industrial hygiene objective of the plant
Actively supports the plant vision and technology strategy and provide coaching to engineers & technicians.
Actively looks for collaboration, benchmarks best practices within MD&D network and beyond as well as competitor activities.
Applies the standards of the J&J related Change Management principles.
Applies LEAN and Six Sigma principles
Partners with operations in the investigation / correction of process failure.
Participate in audits to support of internal audit and external audit programs.
Partner with operations for investigation/correction of process failure.
Review & Approve QMS (Quality System Documents).
Provide technical guidance to all departments related to product and process knowledge.
Stabilization of New technology/Equipment and handing over to Process Owner.
Partner closely with different key manufacturing functions supervisors (Production, Maintenance,              Engineering, EHS&S, Quality Assurance, NPI, Planning, Finance Procurement).
Connect with Ethicon Global Engineering Platform leads/ Maintenance/Supply Chain Communities       to use confirmed solutions or available standards.
GENERAL RESPONSIBILITIES:

Responsible for communicating business related issues or opportunities to next management level.
Responsible for ensuring that subordinates follow all Company guidelines related to Health, Safety and Environmental practices and that all resources needed to do so are available and in good condition, if applicable
Responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures
Performs other duties assigned as needed

Master’s Degree in Engineering/ M.Pharma/Msc Microbiology from reputed college with minimum 6 years of experience or Bachelor’s degree in Engineering with minimum 10 years of experience.

Prior experience in sterilization / Aseptic manufacturing required.

Key Qualifications

Bachelors

Education

B.E

Skills

Sterilization,Aseptic,Regulatory Audits,

Industry

Pharma/Biotech/Clinical Research

Gender Preference:

Female

Job Type:

Full Time

Diversity Tags:

Not Applicable