Scientist III

Pfizer • Andover, MA

2d • $82,700 - $133,900 • Onsite

About The Position

At Pfizer, every day is an opportunity to make a difference in patients' lives. Your contributions will directly impact patient care, as you work within a flexible, innovative, and customer-oriented culture rooted in science and risk-based compliance. By joining our team, you will help uphold a quality culture that adapts and evolves to meet the needs of patients, ensuring that every product we deliver meets the highest standards of safety and efficacy. What You Will Achieve In this role, you will: Contribute to the completion of moderately complex projects related to biopharmaceutical facilities, including environmental and utility monitoring programs and cleanroom design Manage your own time to meet agreed targets; develop plans for short-term work activities on own projects (timelines, work plans, deliverables) within a Work Team Develop and demonstrate strong knowledge/understanding of the principles, concepts, and compliance requirements set forth by major-market regulatory bodies, Pfizer, and local site standards, relative to biopharmaceutical facilities and utilities. Act as a technical resource for environmental and utility monitoring programs, and cleanroom design. Serve as the chairperson of the environmental review committee Understand fundamental business drivers such as production plan of record, regulatory compliance, and continuous improvement. Explore and apply enhancements to programs based on efficiencies, risk-based approaches, and changes to pharmaceutical regulations. Make decisions to resolve moderately complex problems in standard situations in support of environmental and utility investigations Provide feedback on changes to standard methods and techniques when necessary Work under general supervision with minimal guidance. Uses a variety of communication tools and techniques to troubleshoot difficult issues and works to establish consensus. Tools include Mobile Data Acquisition (MODA), gLIMS, electronic Quality Management System (eQMS), Environmental Monitoring Data Analytics (EMDA). Author and approve critical documents, Change Controls, and Risk Assessments using PGS Documentation Management System (PDOCs), and eQMS. Present data and program overviews as well as technical rationale during routine quality management reviews, as well as regulatory and corporate audits and inspections.

Requirements

• Applicant must have a bachelor's degree with at least 2 years of experience; OR a master's degree with 0+ years of experience; OR an associate's degree with 6 years of experience; OR a high school diploma (or equivalent) and 8 years of relevant experience.
• Demonstrated technical knowledge of biopharmaceutical facility classifications, and monitoring (including critical utilities such as water, steam, and HVAC)
• Proven track record of independently accomplishing complex data analyses as well as independent and creative thinking when exploring deviation root-causes.
• Excellent written and verbal communication skills
• Strong interpersonal abilities
• Basic computer skills, including data entry and/or verification with a high level of attention to detail

Nice To Haves

• Strong background in leading continuous improvement projects
• Demonstrated expertise in establishing facility and utility design, classification, and monitoring practices, as well as defending such practices during regulatory audits
• Proficiency with common microbial and/or viral inactivation and contamination prevention mechanisms
• Familiarity with ICHQ9 and/or risk management tools such as FMEA, RRF, and HAZOP
• Experience using common AI tools, including generative technologies such as ChatGPT or Microsoft Copilot, to support problem solving and enhance productivity.

Responsibilities

• Contribute to the completion of moderately complex projects related to biopharmaceutical facilities, including environmental and utility monitoring programs and cleanroom design
• Manage your own time to meet agreed targets; develop plans for short-term work activities on own projects (timelines, work plans, deliverables) within a Work Team
• Develop and demonstrate strong knowledge/understanding of the principles, concepts, and compliance requirements set forth by major-market regulatory bodies, Pfizer, and local site standards, relative to biopharmaceutical facilities and utilities.
• Act as a technical resource for environmental and utility monitoring programs, and cleanroom design.
• Serve as the chairperson of the environmental review committee
• Understand fundamental business drivers such as production plan of record, regulatory compliance, and continuous improvement.
• Explore and apply enhancements to programs based on efficiencies, risk-based approaches, and changes to pharmaceutical regulations.
• Make decisions to resolve moderately complex problems in standard situations in support of environmental and utility investigations
• Provide feedback on changes to standard methods and techniques when necessary
• Work under general supervision with minimal guidance.
• Uses a variety of communication tools and techniques to troubleshoot difficult issues and works to establish consensus.
• Author and approve critical documents, Change Controls, and Risk Assessments using PGS Documentation Management System (PDOCs), and eQMS.
• Present data and program overviews as well as technical rationale during routine quality management reviews, as well as regulatory and corporate audits and inspections.

Benefits

• participation in Pfizer’s Global Performance Plan with a bonus target of 10,0% of the base salary
• 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
• health benefits to include medical, prescription drug, dental and vision coverage

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 5,001-10,000 employees