GMP Technical Writer - SOPs, Work Instructions & EHS

Entegee; United States; On-site; USD 65,000 - 95,000; Full time

Job summary

Entegee seeks a Technical Writer to support GMP-regulated manufacturing documentation across facilities, utilities, equipment, maintenance, EHS, and operations. You will translate complex processes into clear, compliant SOPs, work instructions, and training materials.

Collaborating with Engineering, Facilities, EHS, and SMEs, you’ll ensure accurate documentation, manage revisions, and support change control in a regulated environment.

Qualifications

• Technical writing experience in pharmaceutical, biotech, medical device, or other regulated manufacturing.
• GMP documentation experience, including SOPs and work instructions.
• Experience documenting facilities, utilities, equipment, engineering, or EHS processes.

Responsibilities

• Develop and revise SOPs, work instructions, inspection documents, EHS materials, and training content.
• Work with Engineering, Facilities, EHS, Operations, and SMEs to validate technical information.
• Translate complex procedures into clear, compliant documentation.
• Support document control, approvals, revisions, and change control.

Skills

Technical writing

GMP documentation

Regulated manufacturing

Job description

Entegee seeks a Technical Writer to support GMP-regulated manufacturing documentation across facilities, utilities, equipment, maintenance, EHS, and operations. You will translate complex processes into clear, compliant SOPs, work instructions, and training materials.

Collaborating with Engineering, Facilities, EHS, and SMEs, you’ll ensure accurate documentation, manage revisions, and support change control in a regulated environment.