CQV Lead/ Engineer

1 day ago

Hyderabad, Telangana, India Hyde Engineering + Consulting Full time US$ 90,000 - US$ 1,20,000 per year

This position shall perform commissioning and qualification of Pharmaceutical equipment, including any or all of systems for Oral Solid Dosage, Injectables, Fill/Finish. Equipment's like RMG, CoMil, Tablet press, Coating Machine, blister packing machine, Vial Filling Line, PFS Line, Isolators (Negative & Positive), RABs (Open and Closed), GL Reactors, Dryer, Nutsche Filters, Centrifuges, Lyophilizers, etc

Responsibilities

  • Develop CQMP, VMP, FRA, cGMP review sheet, interdependencies
  • Develop System boundary, URS, SCA/SLIA, CLIA, DQR, SRA/QRA, SAT protocol, commissioning protocol, IQ protocol, OQ protocol, PQ protocol.
  • Develop process validation and cleaning validation protocol
  • Execute Commissioning, qualification and validation activities for Pharma Process Equipment's for API, Fill/Finish and OSD.
  • Review, analyze and interpret system performance data for completed validation and prepare final report packages by summarizing the data.
  • handling of deviation/ discrepancy, Investigation , CAPA .
  • Promote cGMP and regulatory compliance into assigned projects.
  • Exercise GDP, ALCOA, practice while execution.
  • Exercise good judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions.
  • Hands on Experience with Pharma Process Equipments.
  • Drafting of equipment operation SOP's

Qualifications & Other Requirements

  • BS/MS in Engineering (Chemical, Pharma).
  • 4-10 years in validation, quality systems, operations, engineering or any combination thereof.
  • Experience in multiple GMP validation disciplines with advanced technical knowledge.
  • Validation experience using , traditional, risk based, Hybrid approach.
  • Knowledge of Validation Lifecycle approach (URS, FRS, FAT/SAT, Commissioning IQ, OQ, & PQ Protocols, etc.) guidelines, international regulatory requirements and standards.
  • Experience working with Documentum or Maximo a plus.
  • Experience interacting with or creating material for representatives of regulatory agencies and executive level staff.
  • Experience with investigations into manufacturing deviations and determination of product impact potential, root cause and corrective actions.
  • Strong verbal and written communication skills; excellent organizational and time utilization skills
  • Ability to work independently and within project teams.
  • Industry experience related to cGMP drug manufacturing, validation, and chemical process design
  • Strong computer knowledge including Microsoft Office products

  • CQV Engineer — EMS

    1 day ago

    Hyderabad, Telangana, India Hyde Engineering + Consulting Full time US$ 80,000 - US$ 1,20,000 per year

    Position: CQV Engineer — EMS and BMS RoomLocation: IndiaThis position shall perform commissioning and qualification of EMS and BMS Systems in Pharma/Biopharma Facilities.ResponsibilitiesDevelop URS, risk assessment, system impact assessments, validation plans, protocols and reports that support the qualification and validation of systems.Develop and...

  • Lead Engineer

    2 weeks ago

    Hyderabad, Telangana, India Medtronic Full time ₹ 15,00,000 - ₹ 20,00,000 per year

    At Medtronic you can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all. You'll lead with purpose, breaking down barriers to innovation in a more connected, compassionate world.A Day in the LifeAs a Lead Engineer of the MEIC, you will collaborate with the sustenance and engineering teams...

  • Lead Engineer

    3 weeks ago

    Hyderabad, Telangana, India Inspire Brands Hyderabad Support Center Full time

    About Inspire Brands Hyderabad Support CenterInspire Brands is disrupting the restaurant industry through digital transformation and operational efficiencies The companys technology hub Inspire Brands Hyderabad Support Center India will lead technology innovation and product development for the organization and its portfolio of distinct brands The...

  • Engineering Lead

    4 weeks ago

    Hyderabad, Telangana, India Wise Full time

    Company Description : Wise is a global technology company, building the best way to move and manage the worlds money.- Min fees.- Max ease.- Full speed. Whether people and businesses are sending money to another country, spending abroad, or making and receiving international payments, Wise is on a mission to make their lives easier and save them money. As...

  • Lead Engineer

    1 day ago

    Hyderabad, Telangana, India Quest Global Full time US$ 1,50,000 - US$ 2,00,000 per year

    Job Requirements Job Title: Lead Engineer – SystemC Experience: 10+ yearsResponsibilities: Lead design and modeling using SystemC for complex SoC/ASIC projects.Drive architecture exploration, performance modeling, and transaction-level modeling (TLM).Collaborate with hardware and software teams for integration and validation.Mentor junior engineers and...

  • Software Engineering Lead

    2 days ago

    Hyderabad, Telangana, India beBeeDevelopment Full time US$ 2,00,000 - US$ 2,50,000

    Senior Software Development EngineerWe are seeking a highly skilled Senior Software Development Engineer to join our Global Product and Technology team.">Job ResponsibilitiesLead the development of scalable enterprise solutions and drive improvements that enable exceptional operational excellence standards.Design and develop innovative frameworks and...

  • Lead Engineer

    4 weeks ago

    Hyderabad, Telangana, India MosChip Semiconductor Technology Limited Full time

    Job DescriptionRequirements- Must have experience in leading client projects- Must be good at Honouring Committed Schedules, Quality Delivery, Clarity in Communication- Must have full command over major blocks of Serdes like Tx or Rx- Must be good at understanding the CAD flow environment of Clients- Must be able to guide Layout team to fix the simulation...

  • Lead Engineer

    1 week ago

    Hyderabad, Telangana, India Inspire Brands Hyderabad Support Center Full time

    About Inspire Brands Hyderabad Support Center Inspire Brands is disrupting the restaurant industry through digital transformation and operational efficiencies The company s technology hub Inspire Brands Hyderabad Support Center India will lead technology innovation and product development for the organization and its portfolio of distinct brands The...

  • Leading Software Engineer

    4 days ago

    Hyderabad, Telangana, India beBeeEngineering Full time US$ 2,00,000 - US$ 3,00,000

    Senior Engineering Leadership RoleWe are seeking highly skilled and experienced engineering leaders to drive our team's success. As a Senior Engineering Manager, you will be responsible for aligning product vision, leading high-performing teams, and delivering exceptional results.Key ResponsibilitiesAlign the product vision by collaborating with...

  • Lead Engineer II

    1 day ago

    Hyderabad, Telangana, India FMC Full time ₹ 15,00,000 - ₹ 20,00,000 per year

    Job PurposeAt TechnipFMC, we deliver critical projects of a scale, scope and difficulty that you simply wont find anywhere else. We are looking for aLead Engineer II - Installation Engineeringwith previous 10+yrs experience in Subsea Oil & Gas field as installation engineerEnsure work is performed in compliance with the established design rules and...