SME Sterile Filling

Sun Pharmaceuticals
Indiana, Pennsylvania 15705 United States  View Map
Posted: Jun 09, 2026
  • Full Time
  • Federal Government
  • Summary

    TitleSME FillingLocationMumbai / VadodaraKey ResponsibilitiesAt Sun Pharma, we commit to helping you Create your own sunshine by fostering an environment where you grow at every step, take charge of your journey and thrive in a supportive community.Are You Ready to Create Your Own Sunshine?As you enter the Sun Pharma world, you'll find yourself becoming better every day through continuous progress. Exhibit self‑drive as you take charge and lead with confidence. Additionally, demonstrate a collaborative spirit, knowing that we thrive together and support each other's journeys.JOB DESCRIPTIONFollowing are the key requirements:Expertise in operation of below process and equipments:To handle aseptic and lyophilisation area.To handle process like filtration, filling, Lyophilizer loading and unloading, lyophilisation process and capping.To handle the process equipments and its trouble shooting like filling machine, capping machine, Lyophilizer loading and unloading system, Lyophilizer, filtration skid, and isolators, VHP pass box, mobile LAF etc.Exposure to review the Smoke study of entire filling line and process like filtration, filling assembly, filling operation, aseptic intervention during filling, loading and unloading, smoke study in static and dynamic conditions. Take / suggest appropriate actions for remediation of smoke.Knowledge about aseptic practices, aseptic behaviours, media fill simulation, aseptic gowning and de‑gowning process, aseptic area cleaning and sanitization process , personal gowning qualification.Good technical knowledge to train an upskill operators on filling line activities.Do benchmarking and propose upgradation to meet regulatory expectations.Exposure to performed filter integrity testing of product filters and air vent filters along with PUPSIT mechanism.Handling and training of procedure like line clearance, aseptic intervention handling etc.Have expertise in qualification of new equipment, area cleaning and sanitization etc.Exposure for User requirement specification, Design qualification, Installation qualification, operational qualification and performance qualification.To prepare new standard operating procedure for process and equipments.Experience for preparation of batch manufacturing records.To handle communication with vendor and procurement team on procurement to design parts of new equipments.To ensure compliance to cGMP and documentation for various production activities.Ensure proper planning and execution of the qualification activity in accordance with the plan and allocation of man power.Travel EstimateUp to 40-50%Job RequirementsEducational QualificationBachelors degreeExperience13+ years expertise with manufacturing filling machines and processesYour Success Matters to UsAt Sun Pharma, your success and well‑being are our top priorities! We provide robust benefits and opportunities to foster personal and professional growth. Join us at Sun Pharma, where every day is an opportunity to grow, collaborate, and make a lasting impact. Lets create a brighter future together!Disclaimer: The preceding job description has been designed to indicate the general nature and level of work performed by employee within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities, and qualifications required of employees as assigned to this job. Nothing herein shall preclude the employer from changing these duties from time to time and assigning comparable duties or other duties commensurate with the experience and background of incumbent(s).We provide equal employment opportunities for all current employees and applicants for employment. This policy means that no one will be discriminated against because of race, religion, creed, color, national origin, nationality, citizenship, ancestry, sex, age, marital status, physical or mental disability, affectional or sexual orientation, military or veteran status, generic predisposing characteristics or any other basis prohibited by law.#J-18808-Ljbffr

  • Job Description

    TitleSME FillingLocationMumbai / VadodaraKey ResponsibilitiesAt Sun Pharma, we commit to helping you Create your own sunshine by fostering an environment where you grow at every step, take charge of your journey and thrive in a supportive community.Are You Ready to Create Your Own Sunshine?As you enter the Sun Pharma world, you'll find yourself becoming better every day through continuous progress. Exhibit self‑drive as you take charge and lead with confidence. Additionally, demonstrate a collaborative spirit, knowing that we thrive together and support each other's journeys.JOB DESCRIPTIONFollowing are the key requirements:Expertise in operation of below process and equipments:To handle aseptic and lyophilisation area.To handle process like filtration, filling, Lyophilizer loading and unloading, lyophilisation process and capping.To handle the process equipments and its trouble shooting like filling machine, capping machine, Lyophilizer loading and unloading system, Lyophilizer, filtration skid, and isolators, VHP pass box, mobile LAF etc.Exposure to review the Smoke study of entire filling line and process like filtration, filling assembly, filling operation, aseptic intervention during filling, loading and unloading, smoke study in static and dynamic conditions. Take / suggest appropriate actions for remediation of smoke.Knowledge about aseptic practices, aseptic behaviours, media fill simulation, aseptic gowning and de‑gowning process, aseptic area cleaning and sanitization process , personal gowning qualification.Good technical knowledge to train an upskill operators on filling line activities.Do benchmarking and propose upgradation to meet regulatory expectations.Exposure to performed filter integrity testing of product filters and air vent filters along with PUPSIT mechanism.Handling and training of procedure like line clearance, aseptic intervention handling etc.Have expertise in qualification of new equipment, area cleaning and sanitization etc.Exposure for User requirement specification, Design qualification, Installation qualification, operational qualification and performance qualification.To prepare new standard operating procedure for process and equipments.Experience for preparation of batch manufacturing records.To handle communication with vendor and procurement team on procurement to design parts of new equipments.To ensure compliance to cGMP and documentation for various production activities.Ensure proper planning and execution of the qualification activity in accordance with the plan and allocation of man power.Travel EstimateUp to 40-50%Job RequirementsEducational QualificationBachelors degreeExperience13+ years expertise with manufacturing filling machines and processesYour Success Matters to UsAt Sun Pharma, your success and well‑being are our top priorities! We provide robust benefits and opportunities to foster personal and professional growth. Join us at Sun Pharma, where every day is an opportunity to grow, collaborate, and make a lasting impact. Lets create a brighter future together!Disclaimer: The preceding job description has been designed to indicate the general nature and level of work performed by employee within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities, and qualifications required of employees as assigned to this job. Nothing herein shall preclude the employer from changing these duties from time to time and assigning comparable duties or other duties commensurate with the experience and background of incumbent(s).We provide equal employment opportunities for all current employees and applicants for employment. This policy means that no one will be discriminated against because of race, religion, creed, color, national origin, nationality, citizenship, ancestry, sex, age, marital status, physical or mental disability, affectional or sexual orientation, military or veteran status, generic predisposing characteristics or any other basis prohibited by law.#J-18808-Ljbffr

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