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About the Role

The position is a key member of the Pearl River team, accountable for coordination and management of documentation and documentation systems at the Pearl River site. The role is a system coordinator for engineering and operations documentation management systems including Computerized Maintenance Management System, Electronic Logbooks System (SDS), Master Batch records and Standard Operating Procedures. Experienced in Manufacturing of Pharmaceutical/Biotechnology and associated manufacturing equipment.

Responsibilities

Develops data elements in the CMMS for support of engineering and maintenance including equipment details, maintenance plans, maintenance schedules and work order task plans.
Administers CMMS system.
Authors, reviews and approves Master Production Batch Records to support manufacturing operations.
Authors, reviews and approves electronic logbooks and forms in SDS.
Authors, reviews and approves standard operating procedures to support engineering and manufacturing operations.
Manages Change Requests, Change Notices and Periodic Review of production and engineering documentation.
Coordinates commitment and quality drivers for MBR, FORMS, Maintenance Tasks and SOP updates to ensure required updates are coordinated, streamlined and efficiently implemented.
Reviews and files executed maintenance and production documents in coordination with the QARM documentation group.
Manages and reviews data in PGS electronic documentation systems.
Coordinates issuance of and reconciliation of cGMP maintenance plans, SOPs, Forms and MBRs.
Support regulatory/internal audits.

Requirements

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 with knowledge and experience with technologies digital systems used in the pharmaceutical industry.
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.
Occasional need for off hours work (evenings, weekends).
Aseptic/Personnel Safety gowning requirements.
Close working relationship and matrix management of activities including: Directs interactions across a matrix of functions (Operations, Technical Services, Engineering, Supply Chain, QC and QA) to assure compliant and timely delivery and reconciliation of documentation for manufacturing and engineering/maintenance.
Routine interactions with site functions including Quality, QC, EHS, Maintenance/Engineering/Automation, Technical Services, Supply Chain, Digital, Procurement and Finance.
Matrix responsibility for deliverables coordinating with project teams of up to 5-10 colleagues.
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

CMMS
Electronic Logbooks System (SDS)
Master Batch records
Standard Operating Procedures
cGMP
FDA rules and regulations
Data analysis
Trend monitoring
Digital systems used in the pharmaceutical industry
ChatGPT
Microsoft Copilot
Responsible AI practices
Risk management
Ethical use

Location

On Premise

Work Type

On Premise
Full-time

Experience Level

5+ years experience
2+ years of experience

Education Level

Associates Degree
BA/BS
MBA/MS

Salary/Compensations

$82,700.00 - $137,900.00
bonus target of 10.0% of the base salary

Benefits

401(k) plan with Pfizer Matching Contributions
Additional Pfizer Retirement Savings Contribution
Paid vacation, holiday and personal days
Paid caregiver/parental and medical leave
Health benefits to include medical, prescription drug, dental and vision coverage
Relocation assistance may be available based on business needs and/or eligibility.

About the Company

Pfizer reports payments and other transfers of value to health care providers as required by federal and state transparency laws and implementing regulations.
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.
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.
Manufacturing

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.