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Job Location | Delhi |
Education | Not Mentioned |
Salary | Not Disclosed |
Industry | Pharma / Biotech |
Functional Area | Service / Installation / Repair |
EmploymentType | Full-time |
Preferred QualificationBachelors or Masters in EngineeringTarget years of experience8 to 14 yearsOther CertificationsYellow / Green belt certificationTechnical SkillsExperience in Process Engineering aspects related to sterile drug product / injectables manufacturingHolistic understanding of TS equipment train i.e Formulation process equipments, automation hands on experience, stopper processing Filling, Terminal sterilization and visual inspection.Hands on experience of parenteral process development and manufacturing.Good knowledge on Sterile pharma equipment and its engineering aspects.Problem solving skillsProcess analytical skillsHands on experience leading the investigations independently.Yellow belt certification is a must.Candidates who have submitted M2 or green belt project will be preferredStandards, Processes & PoliciescGMP and GDPBehavioral/Any Other SkillsGood Communication & Presentation SkillsEffective negotiation, influential and Interpersonal SkillsLeadership SkillsResponsibilitiesCoordination with Production, Engineering, Validation and Quality as per requirements to achieve the business requirements of Technology Transfer/Product Transfer activities.To Provide technical support for the process and equipments during technology transfer.Technical support for Investigations and CAPAs for Process equipment.To ensure and adhere the Pfizer EHS requirements for safety at the work.To lead and Coordination with internal teams mechanical, Instrumentation and Automations as per functional requirements and to build good working relationship with cross functional and inter departmental teams to lead the entire project team of all disciplines.Engineering support for Equipment Qualification activities DQ, FAT, recipient of equipment, SAT, Commissioning, IQ, OQ, PQ-qualification of equipment as per the Qualification protocols and Technical Support to user for various deliverables.Responsible for preparation of various regulatory inspections, audits and need based active participation during audits, Standardization of Engineering Systems through Planning & Monitoring, Benchmarking, Facility Technical Audits, and Inventory & Contract Management.Provides process engineering support for site-to-site parenteral product transfers by interfacing with cross functional departments across sites.Conducts equipment and process related technical investigations and makes recommendations on corrective Prepares, reviews, and provides input on user requirements specification (URS) documents and P&IDsWill lead activities to implement novel technologies for process improvements to increase yield and reduce process variabilityLeverage PAT tools for rationale-based product transfers between sites and across scalesBe able to apply QbD and DOE principles during the design of investigation studiesBasic understanding of mathematical and statistical modellingProvides necessary technical support to manufacturing, validation and engineering teams as requiredDesigns experimental plan and drafts technical reports summarizing laboratory results as part of investigationsEnsure the compliance to cGMP/cGLP, organizational procedures and practicesInvolve in manufacturing, Validations / engineering related CAPAs and monitor the effectiveness of CAPAsSeek training from technology vendors and train the end users,
Keyskills :
green beltuser requirementsequal employment opportunityprocess developmentcontinuous improvement facilitationdocumentationqualitystatistical modelingtechnical supportengineering supporttechnical reportstechnical audits