Sr Associate Operations & Engineering Documentation
Job Location:
Pearl River, NY - USA
Yearly Salary:
Posted:
Application Deadline:
Vacancies:
Job Summary
ROLE SUMMARY
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.
ROLE RESPONSIBILITIES
What You Will Achieve
In this role you will:
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 logbook 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 requires 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.
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 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 includingrisk management and ethical use
PHYSICAL/MENTAL REQUIREMENTS
Sharp focus practical and disciplined.
NON-STANDARD WORK SCHEDULE TRAVEL OR ENVIRONMENT REQUIREMENTS
Occasional need for off hours work (evenings weekends).
Aseptic/Personnel Safety gowning requirements.
ORGANIZATIONAL RELATIONSHIPS
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.
PHYSICAL/MENTAL REQUIREMENTS
Sharp focus practical and disciplined.
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
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.
Sunshine Act
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EEO & Employment Eligibility
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. This position requires permanent work authorization in the United States.
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ManufacturingRequired Experience:
Senior IC
About Company
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