Senior Associate - Downstream Validation

Posted Yesterday
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Vizag, Vishākhapatnam, Andhra Pradesh, IND
In-Office
Senior level
Artificial Intelligence • Healthtech • Machine Learning • Natural Language Processing • Biotech • Pharmaceutical
We’re in relentless pursuit of breakthroughs that change patients’ lives.
The Role
Leads downstream visual inspection and packing equipment validation for sterile injectable products. Responsibilities include developing validation protocols, executing equipment qualifications and process validation batches, supporting technology transfers, evaluating critical process parameters, troubleshooting manufacturing issues, conducting investigations and CAPAs, preparing defect kits, training personnel, and applying regulatory and continuous improvement practices.
Summary Generated by Built In
Why Patients Need You
Pfizer's purpose is to deliver breakthroughs that change patients' lives. Research and Development is at the heart of fulfilling Pfizer's purpose as we work to translate advanced science and technologies into the therapies and vaccines that matter most. Whether you are in the discovery sciences, ensuring drug safety and efficacy or supporting clinical trials, you will apply cutting edge design and process development capabilities to accelerate and bring the best in class medicines to patients around the world.
What You Will Achieve
As an Associate Manager, you will be at the center of our operations and you'll find that everything we do, every day, is in line with an unwavering commitment to quality. Your significant experience of applying knowledge of principles, concepts, and practices of the discipline will make you a critical member of the team.
Your skill and knowledge on Visual Inspection & Packing will help in making decisions that contribute for robust process of the products that are being manufactured at Vizag site. You are proactive in contributing to all team discussions and creating an environment of collaboration.
It is your innovative scientific temperament that will help in making Pfizer ready to achieve new milestones and help patients across the globe.
How You Will Achieve It
B. Pharm/ M. Pharm/M.S (Pharmacy)/M.Sc. (preferably with the specialization of Pharmaceutics or Industrial Pharmacy) , 6+ years of experience on Visual inspection and packing equipment validation function in sterile dosage form facility, Formulation Development/ Product Development/ Process Development/ Technology Transfer/ Production of Injectable formulations to cater regulated market
  • Hands on experience in Visual inspection & packing automation technologies. (SD, Camera Vision, HVLD, Pressure/Vacuum, line master etc.,)
  • Provides support for site-to-site parenteral product/process transfer by interfacing with cross functional departments across sites.
  • Knowledge on the Validation concepts and ability to train the people.
  • Able to develop Validation protocols for equipment.
  • Prepare study protocols, Gap assessment, Risk assessment reports, recipe parameter recommendations, and CPP requirements in the developed recipe parameters.
  • Evaluate Visual Inspection & Packing Process Parameters/ CPPs for Scale up and Exhibit batches manufacturing.
  • Actively support in execution of Process Validation batches, Equipment Qualifications, validations/recipe establishment.
  • Familiar with US FDA Guidelines, PDA & industry practices there by implementing Continuous Improvement Projects.
  • Trouble shooting, ongoing technical support to Manufacturing team for Process validation, Continuous Process Verification and Process improvement
  • Actively involve and drive Investigations related to Process engineering and Equipment to evolve CAPAs and monitor the effectiveness of CAPAs. Be able to apply DMAIC tool to drive investigation studies.
  • Independently carry out all aspects of practical work necessary to provide right first-time results.
  • Preparation of Defect kits for Visual Inspector qualification and Inspection Machine qualifications.
  • Preferable knowledge on statistics for data evaluation and technical inputs
  • Responsible for performing Engineering batches, scaleup batches, and Exhibit batches as part of technology transfer activities.
  • Attend project team and brainstorming meetings and present data.

Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.
To learn more about acceptable and prohibited uses of AI during the recruitment process, please review our candidate AI-use guidelines available on Pfizer Careers .
Quality Assurance and Control

Skills Required

  • B.Pharm, M.Pharm, M.S. in Pharmacy, or M.Sc.
  • At least 6 years of experience in visual inspection and packing equipment validation within a sterile dosage-form facility or related injectable formulation, process development, technology transfer, or production function.
  • Hands-on experience with visual inspection and packing automation technologies, including camera vision, HVLD, pressure/vacuum systems, and line master systems.
  • Experience supporting site-to-site parenteral product or process transfers.
  • Knowledge of validation concepts and ability to train personnel.
  • Ability to develop equipment validation protocols, study protocols, gap assessments, risk assessments, and process parameter recommendations.
  • Experience evaluating visual inspection and packing process parameters and critical process parameters for scale-up and exhibit batches.
  • Experience executing process validation batches, equipment qualifications, validations, and recipe establishment.
  • Familiarity with US FDA guidelines, PDA practices, and pharmaceutical industry practices.
  • Experience troubleshooting and providing technical support for process validation, continuous process verification, and process improvement.
  • Experience conducting process engineering and equipment investigations, developing CAPAs, and applying DMAIC tools.
  • Experience preparing defect kits for visual inspector and inspection machine qualifications.
  • Experience performing engineering, scale-up, and exhibit batches for technology transfer activities.
  • Pharmaceutics or Industrial Pharmacy specialization.
  • Knowledge of statistics for data evaluation and technical analysis.

What the Team is Saying

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Pfizer

Pfizer Compensation & Benefits Highlights

  • Healthcare Strength — Health coverage is described as comprehensive across medical, dental, vision, and mental‑health support, with strong plan options and provider networks. Feedback suggests these programs are a clear standout within the total rewards package.
  • Retirement Support — Retirement programs feature a 401(k) with company matching plus an additional company retirement contribution. Feedback suggests these elements are consistently highlighted as valuable components of overall compensation.
  • Leave & Time Off Breadth — Paid vacation, holidays, and sick time are often characterized as generous, with some locations offering the ability to purchase additional vacation days. Feedback suggests this breadth contributes meaningfully to work‑life balance.

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The Company
HQ: New York, NY
121,990 Employees
Year Founded: 1848

What We Do

Our purpose ensures that patients remain at the center of all we do. We live our purpose by sourcing the best science in the world; partnering with others in the healthcare system to improve access to our medicines; using digital technologies to enhance our drug discovery and development, as well as patient outcomes; and leading the conversation to advocate for pro-innovation/pro-patient policies.

Why Work With Us

We are the inventors, the problem solvers, the big thinkers — those who surmount any hurdle to deliver breakthrough medicines to the people who are counting on them the most.

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