Senior Associate Operations & Engineering Documentation

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, including risk 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

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. Learn more at Pfizer Candidate Site – U.S. Benefits | (uscandidates.mypfizerbenefits.com). 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.

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