Quality Engineer

Quality Engineer

12-month Contract

On-site in Tarrytown, NY

Overview

The Quality Engineer supports a scale-up manufacturing facility with a primary focus on batch record review, management, and documentation stewardship. This role partners with Operations, Tech Transfer, Documentation, Manufacturing, and R&D teams across multiple sites to ensure accurate, complete, and compliant manufacturing documentation.

Secondary responsibilities include authoring and revising technical documents such as work instructions and procedures to support formulation scale-up, process readiness, and technology transfer activities. The ideal candidate is detail-oriented and a highly organized communicator who can work with subject matter experts to ensure documentation quality, consistency, and timely approval.

Requirements

• Batch Record Review and Stewardship Perform detailed batch record review to ensure accuracy, completeness, and compliance with established procedures and regulatory expectations.
• Act as a documentation steward, ensuring alignment between batch records, work instructions, and supporting technical documents.
• Identify documentation gaps, inconsistencies, or risks and proactively communicate issues to subject matter experts and leadership.
• Document Authoring and Revision Author, revise, and update manufacturing documentation, including work instructions, procedures, technical reports, verification reports, and supporting studies.
• Support updates to existing work instructions to reflect process changes, scale-up activities, and tech transfer requirements.
• Collaborate cross-functionally with R&D, Manufacturing, Tech Transfer, and Documentation teams across multiple sites.
• Participate in project- and department-level meetings to ensure timely and successful completion of documentation deliverables.
• Provide documentation support for pre-manufacturing product development activities as needed.

Qualifications

• Required Knowledge, Skills, and Experience 5–8 years of demonstrated experience in technical writing or batch record review within a scientific, engineering, or manufacturing environment.
• Strong understanding of documentation practices in regulated environments (GMP).
• Strong ability to clearly communicate technical information to diverse audiences.
• Excellent interpersonal, collaboration, and customer-service skills.
• Proven ability to review detailed technical documentation with a high level of accuracy and attention to detail and quality.
• Strong organizational skills and ability to manage multiple documentation deliverables simultaneously.
• Technical Skills High proficiency in Microsoft Office applications, including Word, Excel, PowerPoint, and Visio.
• Preferred Attributes Experience supporting manufacturing, scale-up, or technology transfer activities.
• Self-motivated and proactive communicator comfortable working with cross-functional teams.
• Strong organizational skills and documentation discipline.
• Comfortable working across sites and functions in a regulated environment