Engineering Compliance Technical Writer

Pfizer • Sanford, NC

8d • Onsite

About The Position

At Pfizer, we believe that every role contributes to our mission of improving patients' lives. Whether you are involved in the design and development of manufacturing processes for products or supporting the upkeep of systems, engineering is crucial to ensuring customers and patients receive the medicines they need. By collaborating with our forward-thinking engineering team, you'll play a pivotal role in accelerating the delivery of medicines to the world. What You Will Achieve In this role, you will:
Documentation Independently author, revise, and maintain controlled engineering documentation, including SOPs, work instructions, job aids, forms, and system documentation supporting maintenance, utilities, and engineering systems. Translate complex engineering and maintenance processes into clear, accurate, and executable documentation aligned with site and enterprise standards. Serve as a documentation subject matter expert within Engineering, advising teams on documentation best practices, clarity, and structure. Engineering Change & Compliance Support engineering change control by ensuring documentation accurately reflects approved technical changes. Incorporate corrective actions from deviations, equipment issues, and CAPAs into controlled documentation. Partner with Engineering Compliance leads to ensure documentation supports inspection readiness for engineering systems. Provide weekly commitment, CAPA, and effectiveness reports to Tier 2 leaders Cross‑Functional Collaboration Collaborate with Engineering, Maintenance, Utilities, Validation, and Quality stakeholders to gather technical content and resolve document comments. Facilitate document review and approval cycles while maintaining engineering ownership and documentation integrity. Periodic Review & Sustainment Own and execute scheduled periodic reviews of engineering documentation and templates to ensure content remains current, compliant, and inspection‑ready. Maintain documentation lifecycle activities in accordance with established procedures and timelines.

Requirements

• High school diploma (or equivalent) with 8+ years of experience or associate’s degree with 6+ years of experience or BA/BS with 2+ years of experience or MBA/MS with any years of relevant experience
• Demonstrated experience in Good Manufacturing Practices (GxP)
• Ability to provide technical solutions for complex problems through equipment/process knowledge
• Familiarity with site Learning Management System and processes
• Proven ability to lead and work in cross-functional teams
• Excellent leadership, communication, and interpersonal skills
• Strong documentation skills and attention to detail

Nice To Haves

• Experience supporting engineering, maintenance, utilities, or validation documentation in pharmaceutical or regulated manufacturing environments.
• Familiarity with deviation, CAPA, and inspection readiness activities.
• Experience contributing to site or enterprise documentation harmonization initiatives.
• Deep understanding of site operations
• Experience with regulatory agency requirements and audits
• Ability to develop and implement technical and operational standards
• Excellent organizational and time management skills
• 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

Responsibilities

• Independently author, revise, and maintain controlled engineering documentation
• Translate complex engineering and maintenance processes into clear, accurate, and executable documentation
• Serve as a documentation subject matter expert within Engineering
• Support engineering change control by ensuring documentation accurately reflects approved technical changes
• Incorporate corrective actions from deviations, equipment issues, and CAPAs into controlled documentation
• Partner with Engineering Compliance leads to ensure documentation supports inspection readiness for engineering systems
• Provide weekly commitment, CAPA, and effectiveness reports to Tier 2 leaders
• Collaborate with Engineering, Maintenance, Utilities, Validation, and Quality stakeholders to gather technical content and resolve document comments
• Facilitate document review and approval cycles while maintaining engineering ownership and documentation integrity
• Own and execute scheduled periodic reviews of engineering documentation and templates to ensure content remains current, compliant, and inspection‑ready
• Maintain documentation lifecycle activities in accordance with established procedures and timelines

Benefits

• 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
• health benefits to include medical, prescription drug, dental and vision coverage

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Education Level: High school or GED