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About the Role

The position is a key member of the Pearl River team, accountable for effective implementation, execution and sustaining of the site Continuous Improvement projects and Validation Master Plan Program Elements for clean utilities and equipment cleaning. The role manages execution of validation and equipment project deliverables at the Pfizer PGS Pearl River site. Sets targets for project implementation including milestones / deliverables / goals which are aligned with site master validation plan and CI elements. Experienced in Manufacturing of Pharmaceutical/Biotechnology and associated clean utilities/CIP systems.

Responsibilities

Develop and execute cleaning validation, clean utility equipment qualification, protocols and reports to support the site master plan execution.
Authors, reviews and approves technical reports and development studies to support clean utilities and equipment cleaning and equipment projects.
Authors and reviews periodic reviews for utility equipment, filter and cleaning validation.
Authors, reviews and approves development of new and modified Standard Operating Procedures, Job Aids to support manufacturing and clean utility Equipment and processes.
Authors, reviews and approves Validation Plans, Risk Assessments and Validation Strategies.
Manage project milestones as assigned to support new process, technology transfer or equipment installations in collaboration with Operations, Opex and Engineering.
Manages vendor and contract resources to ensure all vendor/contractor work is completed in alignment with Pfizer standards.
Participate in PCT operational huddles (Tier 1/2) and shift huddles (Tier 0).
Support regulatory/internal audits including coordination of internal responses.

Requirements

Strong sense of ownership and accountability.
Lead change with agility, optimism and innovation.
Excellent organization and time management skills.
Demonstrated ability to effectively collaborate with team members within and across functions.
Can articulate the issues and solutions to both the PCT and to senior management.
Knowledge and experience of cGMP and FDA rules and regulations.
Proficiency in data analysis and trend monitoring.
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.
Sharp focus, practical and disciplined.
Shop floor presence (approximately 25%) required in support of manufacturing process.
Heavy gowning requirements working in a clean room environment with cytotoxic materials.
Ability to perform entire work shift under these conditions as necessary.
Daily routine may require moving heavy equipment, standing for long periods of time, and/or walking throughout the suite including up and down stairs.
Must have the ability to lift ~50 pounds.
The incumbent needs to take the necessary safety precautions when working with pressurized systems, steam and/or corrosive chemicals.
Heavy “hands on” mechanical ability or capability.
Occasional need for off hours work (evenings, weekends).
Aseptic/Personnel Safety gowning requirements.
Candidates must be authorized to be employed in the U.S. by any employer.
U.S. work visa sponsorship (such as TN, O-1, H-1B, etc.) is not available for this role now or in the future.
This position requires permanent work authorization in the United States.

Skills

Clean utilities
Equipment cleaning
Validation Master Plan
Continuous Improvement
Pharmaceutical manufacturing
Biotechnology manufacturing
CIP systems
cGMP
FDA rules and regulations
Data analysis
Trend monitoring
Generative AI tools (ChatGPT, Microsoft Copilot)
Responsible AI practices
Risk management
Ethical use of AI
Mechanical ability

Location

Pearl River

Work Type

On Premise
Full-time

Experience Level

5+ years experience with Associates Degree
2+ years of experience with BA/BS
Any years of relevant experience with MBA/MS

Education Level

Associates Degree
BA/BS
MBA/MS

Salary/Compensations

$82,700.00 - $137,900.00
10.0% bonus target

Benefits

401(k) plan with Pfizer Matching Contributions
Additional Pfizer Retirement Savings Contribution
Paid vacation
Paid holiday
Paid personal days
Paid caregiver/parental leave
Paid medical leave
Health benefits (medical, prescription drug, dental, vision)
Relocation assistance may be available

About the Company

Pfizer is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status.
Pfizer also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA.
Pfizer is an E-Verify employer.
Pfizer endeavors to make www.pfizer.com/careers accessible to all users.

Equal Opportunity

Pfizer is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status.
Pfizer also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA.
Pfizer is an E-Verify employer.