Job Description

need 2 references

po client

rate- $60-$70/hour

no opt,cpt and h1b

A full-service Contract Manufacturing Organization (CMO) client in Carlsbad, CA is in need of a Technical Writer Consultant starting on-site on October 20th, until approximately November 21st. It is projected to be 40 hours/week, fully on-site.

This consultant will be critical in supporting the development and qualification of a new cGMP aseptic fill-finish facility. The CMO specializes in Aseptic Fill & Finish, IVD and Life Science kits, Drug-device combo products, and Lyophilization.

Scope of Work:

• Review and assemble vendor (OEM) supplied technical documentation and executed validation documents. Author supplemental validation protocols (wrap-around) to support vendor provided validation documents.
• Author final validation reports from vendor provided executed protocols.
• Draft and revise SOPs, work instructions, validation plans
• Have experience with aseptic processing equipment including autoclaves, parts washers, depyrogenation ovens, WFI, clean steam, CCA and other process equipment.
• Ensure clarity, consistency, and compliance with documentation standards
• Collaborate with vendors, SMEs, QA, and regulatory teams to gather and verify content.

Required Qualifications

• Bachelor's degree in Engineering, Life Sciences, or related field.
• Minimum 5 years of technical writing experience in a GMP pharmaceutical or biotech environment.
• Direct experience with aseptic processing equipment and utility systems (autoclaves, depyrogenation ovens, parts washers, clean steam, WFI, etc.)
• Strong knowledge of regulatory guidelines: 21 CFR 210/211, 820 , ISO 13485 , and current GMP standards.
• Proven experience with protocol writing (IQ/OQ), execution oversight, and deviation resolution.
• Excellent technical writing and documentation skills.
• Ability to work independently and collaboratively onsite in a regulated environment.

when you feel free please contact me [email protected]

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