Description

About the Role:

Actalent is seeking an experience GMP Technical Writer to be embedded onsite with a pharmaceutical or biotechnology client during the early stages of a new manufacturing facility build or major expansion. This role will lead and own the documentation workstream, partnering closely with Facilities/Utilities, Manufacturing, Quality, and Commissioning/Validation teams. The ideal candidate brings greenfield or site‑expansion experience, understands how documentation evolves alongside construction and startup activities, and can drive documentation planning and execution with minimal oversight.

Key Responsibilities

- Lead documentation planning and structure, including hierarchy, taxonomy, numbering conventions, templates, and routing/approval pathways.

- Own the end‑to‑end documentation lifecycle: requirements capture, drafting, review coordination, comment resolution, finalization, and controlled release.

- Facilitate SME working sessions across Facilities/Utilities, Manufacturing, QA, CQV, and EHS to extract requirements, clarify intent, and document decisions.

- Author and maintain GMP documentation, including:

SOPs and Work Instructions

Batch / Production Records (including MBR or eMBR scaffolding as applicable)

Validation‑adjacent documentation (URS inputs, IQ/OQ/PQ protocol shells, summary reports, traceability matrices)

Training aids and one‑point lessons supporting operational readiness

- Align documentation with commissioning and validation activities, ensuring timely support as equipment and utilities come online.

- Implement and maintain version control and change management practices in coordination with Quality and Document Control.

- Provide regular status updates on documentation progress, risks, and decisions needed to maintain momentum.

Required Qualifications

- 7–10+ years of GMP technical writing experience in pharmaceutical, biotechnology, or life science manufacturing environments.

- Demonstrated experience supporting greenfield builds or major site expansions.

- Strong working knowledge of cGMP requirements and CQV/Validation documentation (IQ/OQ/PQ, URS, VMP fundamentals).

- Proven ability to lead SME engagement, translate complex processes into clear, compliant documentation, and drive documents to release.

- Experience working within QMS environments, including document control, change management, and training documentation.

- Excellent writing, organization, and communication skills with strong attention to detail.

- Proficiency with documentation tools such as Microsoft Word, SharePoint, and PDF markup tools; experience with electronic QMS systems is a plus.

Skills

SOP, Technical Writing, Batch Record, GMP, Work instruction, Greenfield, Startup, Change Control, Validation, Document Control

Top Skills Details

SOP,Technical Writing,Batch Record,GMP,Work instruction,Greenfield,Startup,Change Control,Validation,Document Control

Additional Skills & Qualifications

Preferred / Nice to Have

- Experience with aseptic manufacturing, cleanroom operations, or environmental monitoring documentation.

- Exposure to electronic batch record (eBR/MBR) systems or MES platforms.

- Prior consulting experience in an embedded, onsite support role.

- Familiarity with construction‑to‑commissioning transitions and validation readiness activities.

Experience Level

Expert Level

Job Type & Location

This is a Contract position based out of Morrisville, NC.

Pay and Benefits

The pay range for this position is $75.00 - $90.00/hr.

Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following: • Medical, dental & vision • Critical Illness, Accident, and Hospital • 401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available • Life Insurance (Voluntary Life & AD&D for the employee and dependents) • Short and long-term disability • Health Spending Account (HSA) • Transportation benefits • Employee Assistance Program • Time Off/Leave (PTO, Vacation or Sick Leave)

Workplace Type

This is a fully onsite position in Morrisville,NC.

Application Deadline

This position is anticipated to close on Feb 13, 2026.

About Actalent

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.

The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.