Senior Associate - Tech Transfers

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
Manage pharmaceutical technology transfers, process validation, regulatory submissions, and quality systems. Review and approve validation plans, protocols, reports, and technical documents; troubleshoot equipment and process validation issues; analyze testing data and support investigations. Maintain the Site Validation Master Plan, coordinate cross-functional testing, support audits and regulatory queries, and contribute to product transfers, new product development, cleaning validation, deviations, and cost-improvement projects.
Summary Generated by Built In
Use Your Power for Purpose
Every day, our unwavering commitment to quality ensures the delivery of safe and effective products to patients. Our innovative, flexible, and customer-oriented culture is rooted in science and risk-based compliance. Whether you are engaged in development, maintenance, compliance, or research analysis, your contributions have a direct impact on patient care.
What You Will Achieve
In this role, you will:
  • Tech transfer process of new molecules, developmental studies exhibit batches, Process validation & regulatory Submissions.
  • Evaluate, review, and approve validation master plans, protocols, and reports, ensuring compliance with company standards and regulatory requirements.
  • Troubleshoot validation issues for equipment and performance processes, providing expertise for resolution.
  • Conduct statistical analysis of testing results and process anomalies and provide high-level data analysis support for Quality Investigations.
  • Guide the writing, review, and approval of validation process documents and technical reports, ensuring adherence to the latest Pfizer Quality Standards.
  • Contribute to moderately complex projects, manage time effectively, and develop plans for short-term work activities.
  • Manage routine Quality systems such as Change Control, Quality Agreement, Documentation, and Investigations, and coordinate testing with functional groups.
  • Maintain the Site Validation Master Plan, support regulatory audits, and represent engineering validation on site or network teams.
  • Support product transfers, new product development, regulatory queries, cost improvement projects, and Cleaning Validation, ensuring integration of validation schedules in production and participating in deviation investigations.

Here Is What You Need (Minimum Requirements)
  • High school diploma (or equivalent) with 8+ years of experience or associate's degree with 6+ years of experience or BA/BS with 2+ years of experience or MBA/MS with any years of relevant experience
  • Experience in tech transfer process scale ups, Exhibit batches & process validations.
  • Handling multi-market FDA regulations.
  • Proven expertise in Good Manufacturing Practices
  • Strong working knowledge of various quality systems and processes
  • Familiarity with information systems such as Global Document Management System, System Application & Products, and Quality Tracking System
  • Excellent verbal and written communication skills
  • Ability to work independently and in a team environment

Bonus Points If You Have (Preferred Requirements)
  • Strong technical knowledge with validation/qualification of pharmaceutical processes, equipment, utilities, facilities, and/or computer systems
  • Experience with sterile products and medical devices
  • Strong analytical and problem-solving skills
  • Strong organizational and time management skills
  • Ability to mentor and guide other colleagues
  • Experience in regulatory audits and compliance
  • Experience using common AI tools, including generative technologies such as ChatGPT or Microsoft Copilot, to support problem solving and enhance productivity. Demonstrated curiosity for exploring how these tools can improve outcomes and understanding of responsible AI practices, including risk management and ethical use

Work Location Assignment: On Premise
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

  • High school diploma or equivalent with 8+ years of relevant experience
  • Associate degree with 6+ years of relevant experience
  • BA or BS degree with 2+ years of relevant experience
  • MBA or MS degree with relevant experience
  • Experience with technology transfer process scale-ups, exhibit batches, and process validations
  • Experience handling multi-market FDA regulations
  • Expertise in Good Manufacturing Practices
  • Working knowledge of quality systems and processes
  • Familiarity with Global Document Management System, SAP, and Quality Tracking System
  • Excellent verbal and written communication skills
  • Ability to work independently and in a team environment
  • Technical knowledge of validation and qualification for pharmaceutical processes, equipment, utilities, facilities, or computer systems
  • Experience with sterile products and medical devices
  • Strong analytical and problem-solving skills
  • Strong organizational and time management skills
  • Ability to mentor and guide colleagues
  • Experience with regulatory audits and compliance
  • Experience using generative AI tools such as ChatGPT or Microsoft Copilot and understanding of responsible AI practices

What the Team is Saying

Daniel
Anna
Esteban
Pfizer

Pfizer Compensation & Benefits Highlights

  • Healthcare Strength Health coverage is described as comprehensive, spanning medical, dental, vision, and robust mental‑health benefits, with eligible Pfizer medications available at no cost in U.S. plans. Family‑building support and transgender‑inclusive care are explicitly included, alongside wellbeing resources such as a reimbursement wallet and telehealth options.
  • Retirement Support Retirement programs feature a 401(k) with company matching plus an additional Retirement Savings Contribution, complemented by company‑subsidized life, short‑term disability, and long‑term disability insurance. Materials also reference subsidized retiree medical coverage for eligible groups.
  • Leave & Time Off Breadth Paid vacation, holidays, personal days, and paid parental and caregiver leave are consistently highlighted in current U.S. summaries and job postings. Options like buying extra vacation days and transition‑back support strengthen the time‑off offering.

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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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