ROLE SUMMARY
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.
ROLE RESPONSIBILITIES
What You Will Achieve
In this role, you will:
•Develop and execute cleaning validation, clean utility equipment qualification, protocols and reports to support the site master plan execution.
•Author, review and approve technical reports and development studies to support clean utilities and equipment cleaning and equipment projects.
•Author and review periodic reviews for utility equipment, filter and cleaning validation.
•Author, review and approve development of new and modified Standard Operating Procedures, Job Aids to support manufacturing and clean utility Equipment and processes.
•Author, review and approve 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.
•Manage 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.
BASIC QUALIFICATIONS
•Associates Degree with 5+ years experience or BA/BS with 2+ years of experience or MBA/MS with any years of relevant experience.
•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.
ORGANIZATIONAL RELATIONSHIPS
Close working relationship and matrix management of VMP activities including:
•Directs interactions across a matrix of functions (Operations, Technical Services, Engineering, Supply Chain, QC and QA) to assure compliant and timely delivery of deliverables.
•Routine interactions with site functions including: Quality, QC, EHS, Maintenance/Engineering/Automation, Technical Services, Supply Chain and digital.
Matrix responsibility for deliverables coordinating with project teams of up to 10-15 colleagues.
PHYSICAL/MENTAL REQUIREMENTS
•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.
NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS
•Occasional need for off hours work (evenings, weekends).
•Aseptic/Personnel Safety gowning requirements.
Work Location Assignment: On Premise
The annual base salary for this position ranges from $82,700.00 to $137,900.00. In addition, this position is eligible for participation in Pfizer's Global Performance Plan with a bonus target of 10.0% of the base salary. We offer comprehensive and generous benefits and programs to help our colleagues lead healthy lives and to support each of life's moments. Benefits offered include a 401(k) plan with Pfizer Matching Contributions and an additional Pfizer Retirement Savings Contribution, paid vacation, holiday and personal days, paid caregiver/parental and medical leave, and health benefits to include medical, prescription drug, dental and vision coverage. Pfizer compensation structures and benefit packages are aligned based on the location of hire. The United States salary range provided does not apply to Tampa, FL or any location outside of the United States.
Relocation assistance may be available based on business needs and/or eligibility.
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.
