Sr 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

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

Pfizer reports payments and other transfers of value to health care providers as required by federal and state transparency laws and implementing regulations.  These laws and regulations require Pfizer to provide government agencies with information such as a health care provider’s name, address and the type of payments or other value received, generally for public disclosure.  Subject to further legal review and statutory or regulatory clarification, which Pfizer intends to pursue, reimbursement of recruiting expenses for licensed physicians may constitute a reportable transfer of value under the federal transparency law commonly known as the Sunshine Act.  Therefore, if you are a licensed physician who incurs recruiting expenses as a result of interviewing with Pfizer that we pay or reimburse, your name, address and the amount of payments made currently will be reported to the government.  If you have questions regarding this matter, please do not hesitate to contact your Talent Acquisition representative.

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.

Pfizer endeavors to make www.pfizer.com/careers accessible to all users. If you would like to contact us regarding the accessibility of our website or need assistance completing the application process and/or interviewing, please email disabilityrecruitment@pfizer.com. This is to be used solely for accommodation requests with respect to the accessibility of our website, online application process and/or interviewing. Requests for any other reason will not be returned.

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.