Technical Writer

Description

The company is converting warehouse space into production

space and this employee will facilitate the installation of the pharmaceutical

production lines and work with multiple departments to coordinate info and

create new SOP's while validating the new production lines.

Skills

pharmaceutical, production, manufacturing quality, quality

assurance, SOP, Technical writing, Document control, Writing skills, Technical

documentation

Top Skills Details

pharmaceutical, production, manufacturing quality, quality

assurance, SOP writing, Technical writing

Additional Skills & Qualifications

Technical Writer - Pharmaceutical Manufacturing

Required Skills & Prior Experience

Core Prior Experience

• Pharmaceutical / GMP environment experience

o Typically 3-7+ years supporting manufacturing, validation, QA, or MSAT

o Experience working in FDA regulated facilities (21 CFR Parts 210/211)

• Hands on SOP authoring experience

o Writing new SOPs from scratch, not just revising templates

o SOPs covering:

? Manufacturing operations

? Equipment use & cleaning

? Deviations / CAPA

? Change control

? Batch records / MBPRs

• Production line start up or expansion experience

o Supporting new line installation, equipment onboarding, or facility conversions

o Experience documenting process flows that don't yet exist

• Cross functional documentation coordination

o Direct interaction with:

? Engineering

? Manufacturing

? Validation

? Quality Assurance

? Regulatory / MSAT

o Ability to extract technical details from SMEs and convert them into compliant documentation

____

Critical Technical & Regulatory Skills

• GMP Documentation Expertise

o SOP lifecycle management

o Controlled document systems (EDMS)

o Version control and document change history

• Validation Documentation Knowledge

o IQ / OQ / PQ support documentation

o Equipment qualification summaries

o Process validation support documents

• Change Management

o Writing documentation tied to:

? Facility changes

? New equipment

? Product transfers

? Portfolio expansion

• Audit Ready Writing

o Clear, unambiguous, inspection defensible language

o Experience supporting FDA, internal, or customer audits

____

Software / Systems Experience

• Document Control Systems

o Veeva Vault, MasterControl, TrackWise, Documentum, or similar

• Technical Writing Tools

o MS Word (advanced formatting, styles, templates)

o SharePoint / controlled repositories

• Manufacturing Systems (nice to have, not always required)

o MES (e.g., Werum PAS X)

o eQMS platforms

Job Type & Location

This is a Contract to Hire position based out of Hauppauge, NY.

Pay and Benefits

The pay range for this position is $65000.00 - $75000.00/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 Hauppauge,NY.

Application Deadline

This position is anticipated to close on Mar 17, 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 [email protected] (%[email protected]) for other accommodation options.