Technical Writer V with FDA and GMP - Durham, United States - DivIHN Integration Inc

Description

Job Description

Job DescriptionFor further inquiries regarding the following opportunity, please contact one of our Talent Specialists

Rashi at Title:
Technical Writer V (HYBRID)

Location:
Research Triangle Park, NC
Duration: 16 WeeksProven experience as a technical writer, preferably in the pharmaceutical or biotechnology industry

Description:
Possibility for Hybrid work arrangement but 2-3 days onsite will be required.Position Overview

The Technical Writer, reporting to the Director of Facilities will be responsible for writing and developing Standard Operating Procedures (SOPs) and other process documents for the Facilities and Engineering (F&E) department.

This position is eligible for hybrid or possibly fully remote work.Responsibilities

Collaborate with subject matter experts (SMEs) within the Engineering Department to gather information and understand processes while translating workflows into procedures.

Write, revise, and coordinate the maintenance of SOPs, work instructions, training documents and other procedures in accordance with regulatory requirements and industry standards.

Ensure clarity, accuracy, and consistency in all documentation produced, adhering to company templates and guidelines.

Conduct thorough reviews of documents to ensure compliance with internal standards and stated goals and a coherent flow of information.

Work closely with cross-functional teams, including Quality Assurance, Laboratory Managers, and F&E management to gather feedback and incorporate changes as needed.

Education and Experience
Bachelor's degree in a scientific or engineering field or equivalent formal academic / vocational experience is required.
Proven experience as a technical writer, preferably in the pharmaceutical or biotechnology industry.
Familiarity with maintenance workflows, particularly as they relate to computerized maintenance management systems (CMMS).
Ability to translate processes and requirements into technical documentation.
Excellent writing, editing, and proofreading skills with keen attention to detail.
Strong understanding of regulatory requirements, including FDA and GMP.
Experience with process mapping and flowcharting tools.
Proficiency with document management systems and Microsoft Office Suite.
Strong communication and interpersonal skills with the ability to interact effectively with diverse stakeholders

About us:DivIHN, the 'IT Asset Performance Services' organization, provides Professional Consulting, Custom Projects, and Professional Resource Augmentation services to clients in the Mid-West and beyond. The strategic characteristics of the organization are Standardization, Specialization, and Collaboration.
DivIHN is an equal opportunity employer.

DivIHN does not and shall not discriminate against any employee or qualified applicant on the basis of race, color, religion (creed), gender, gender expression, age, national origin (ancestry), disability, marital status, sexual orientation, or military status.