Technical Writer

cGMP Consulting•Worcester, MA

15d•$65,000 - $85,000

About The Position

cGMP Consulting, Inc. is seeking technical writers who would support engineers of all experience levels to provide technical support/ documentation to Engineering and Validation teams with a focus on change management and SOP updates for a variety of on-going projects in the pharmaceutical industry. Knowledge and application of the CFR’s and cGMP’s is preferred. The ideal candidate for this job is resourceful, independent, organized, and capable of working in a fast-paced environment. Assuring a steady and accurate completion of the workload on time is key to success in this position.

Requirements

Bachelors’ degree in Engineering, Science, or a related field of study.
0-2 years’ experience in a GMP manufacturing environment.
Experience in technical writing including drafting standard operating procedures, protocols, and/or reports is preferred.
Familiar with regulatory (FDA) requirements.
Advanced critical thinking and technical writing skills.
Strong organizational, communication, and interpersonal skills.

Nice To Haves

Business minor or coursework is strongly encouraged.

Responsibilities

Author and revise SOPs, Work Instructions, and controlled documents to ensure clarity, compliance, and alignment with current Good Manufacturing Practices (cGMP), regulatory requirements (e.g., 21 CFR Part 11, EU Annex 11), and internal quality standards.
Translate change control records into clear procedural updates by collaborating with QA, Validation, Manufacturing, and Engineering to interpret change requests and accurately reflect them in controlled documentation.
Manage document lifecycle in electronic document management systems (EDMS) such as Veeva Vault, MasterControl, or Documentum, ensuring version control and audit readiness.
Participate in cross-functional change control meetings, including Change Control Board (CCB) or Quality Review Board (QRB) sessions, to gather context, clarify scope, and align on documentation impacts.
Conduct impact assessments for procedural changes, evaluating how proposed changes affect existing SOPs, training materials, and regulatory filings, and identifying required updates.
Ensure traceability and compliance in documentation updates by maintaining clear linkage between change control records, risk assessments (e.g., PFMEA), and revised documents.
Support training deployment for revised procedures by collaborating with Learning & Development to ensure timely training assignment and completion tracking for impacted personnel.
Standardize documentation practices across departments, promoting consistency in formatting, terminology, and structure in line with internal style guides and regulatory expectations.
Prepare documentation for internal audits and regulatory inspections, and respond to document-related queries and CAPAs to support audit readiness.
Drive continuous improvement in documentation processes by identifying inefficiencies in SOP workflows and proposing enhancements to improve clarity, usability, and compliance.