Senior Associate - Tech Transfers

Pfizer; Hinoba-an; On-site; PHP 800,000 - 1,000,000; Full time

Benefits offered by this job

Equal opportunity employer

On-site work availability

Job summary

Pfizer is seeking a qualified engineer to lead technology transfer and validation efforts for new molecules, handling exhibit batches and regulatory submissions. You will evaluate validation master plans and protocols, troubleshoot issues, and perform data analysis to support quality investigations.

The role requires strong knowledge of GMP, quality systems, and cross-functional collaboration, with on-premise work at Pfizer facilities in the Philippines.

Qualifications

• High school diploma or equivalent with 8+ years of experience, or an Associate’s degree with 6+ years, or a BA/BS with 2+ years, or MBA/MS with any years of relevant experience.
• Experience in tech transfer processes, scale-ups, exhibit batches and process validations.
• Familiarity with FDA regulations, GMP quality systems, and information systems such as document management and QA tracking.

Responsibilities

• Lead tech transfer for new molecules and exhibit batches.
• Evaluate, review and approve validation master plans, protocols and reports.
• Troubleshoot validation issues for equipment and processes.
• Perform statistical analysis of testing results and support Quality Investigations.
• Coordinate testing with functional groups and contribute to regulatory submissions.

Skills

Tech transfer

Validation

Quality systems

Statistical analysis

Regulatory submissions

Education

High school diploma + 8+ years experience

Associate’s degree + 6+ years experience

BA/BS + 2+ years experience

MBA/MS + any years experience

Tools

Global Document Management System

SAP (System Applications & Products)

Quality Tracking System

Job description

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 Pfizer careers are like no other. In our culture of individual ownership, we believe in our ability to improve future healthcare, and potential to transform millions of lives. We’re looking for new talent to join our global community, to unearth new innovative therapies that make the world a healthier place.