Process Engineer, Technical Writing for Pharma Gene Therapy Startup Mfg. Facility, Production E[...]

Eliassen Group; Indianapolis (IN); On-site; USD 70,000 - 90,000; Full time

Job summary

A leading pharmaceutical company is seeking a Process Engineer specializing in technical writing for their new gene therapy facility. The role involves developing and revising critical documents such as SOPs and risk assessments while supporting the equipment startup process. Ideal candidates will have a Bachelor's Degree in Engineering and experience in pharmaceutical manufacturing, especially in biologics and gene therapy.

Benefits

Medical insurance

Vision insurance

401(k)

Qualifications

• Bachelor Degree in Engineering or related field.
• Experience in pharmaceutical manufacturing using single-use systems.
• Proficient in MS Word and Visio for documentation.

Responsibilities

• Author and revise SOPs, Equipment-Specific Instructions, and risk assessments.
• Work alongside site process engineers for documentation.
• Draft training materials and observe equipment startup.

Skills

Technical Writing

Documentation

Project Management

Education

Bachelor Degree in Engineering

Tools

MS Word

Visio

Job description

Process Engineer, Technical Writing for Pharma Gene Therapy Startup Mfg. Facility, Production Equipment

Process Engineer, Technical Writing for Pharma Gene Therapy Startup Mfg. Facility, Production Equipment

5 days ago Be among the first 25 applicants

Direct message the job poster from Eliassen Group

Principal Recruiter at Eliassen Group Clinical Solutions (The Evanston Group was acquired by Eliassen)

Process Engineer, Technical Writing for Pharma Gene Therapy Startup Mfg. Facility, Production Equipment

BUSINESS PROBLEM, CONTEXT & INITIATIVE DESCRIPTION

Our Fortune 500 pharmaceutical client is constructing a new manufacturing plant focused in gene therapy, expected to be operational in 2026. As the facility receives delivery of production equipment and start up systems, a high volume of document generation is anticipated. Therefore, our client is seeking 2 Process Engineers for Technical Writing to supplement our client’s teams at the site to support document generation and revision related to delivery of production equipment (which has associated automation systems). The scope of work includes development, drafting, and tracking of various documents including:

• Standard Operating Procedures (SOPs)
• Equipment-Specific Instructions (ESIs)
• Task-Based Risk Assessments
• Verification Documents
• Process-Support Qualification (PSQ) Protocols
• Change Controls
• Operational Control Strategies (OCSs)
• Functional Specifications

This work may also include drafting or revising instructions/language to be used in the Manufacturing

Execution System (MES) but does not require direct editing of the MES or updating of the MES

instructions within the system.

Process Engineers will report into the Associate Director of Process Engineering at the site.

DUTIES / EXPECTATIONS OF THIS ROLE

• Work alongside and supplement our client’s site process engineers at the site
• Author, format, and revise SOPs, ESIs, risk assessments, verification documents, PSQ protocols, engineering protocols, and OCSs as needed.
• This will include the formatting of documents for consistency of layout; to include references to other documents and systems; embedded pictures, videos, and other media to facilitate instruction; and troubleshooting of formatting errors.
• Generate/draft training materials in parallel with procedures and other equipment/process specific documentation
• Observe equipment and system startup and C&Q activities in the facility as-needed to support document drafting and revision
• Draft documents using client’s templates and following the examples laid out in existing documents generated by the site
• Work cross-functionally to support multiple departments
• Required to complete OSHA 10-hour construction training.
• Additional Duties may include:
• Provide support drafting content for change controls
• Provide hands-on support with equipment startup and testing

MUST HAVES – QUALIFICATION SUMMARY

• Bachelor Degree in Engineering or related
• Proficient in applications such as MS Word and Visio to produce and edit documents and diagrams
• Substantial experience in pharmaceutical manufacturing using single-use disposable systems
• Experience in manufacturing biologics is preferred and gene therapy a PLUS
• Startup facility experience is preferred
• Project management experience is preferred
• C&Q (commissioning, qualification) engineering experience preferred/plus

TRAVEL & LOCATION

ONSITE in Lebanon, IN. Monday-Friday, Daylight Schedule (40 hours/week)

START & TERM

Immediate start. 1-year contract term with potential to extend

Seniority level

• Seniority level

  Mid-Senior level

Employment type

• Employment type

  Contract

Job function

• Job function

  Engineering and Writing/Editing

• Industries

  Pharmaceutical Manufacturing

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Inferred from the description for this job

Medical insurance

Vision insurance

401(k)

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