Apply on Employer Site

INCOG BioPharma Services · 3 months ago

Technical Services Tech Writer

Fishers, IN

Full-time

Onsite

New Grad, Entry Level

0+ years exp

INCOG BioPharma Services is a CDMO focused on parenteral injectable drugs, committed to technical excellence and a service-culture mindset. They are seeking a Technical Writer to create clear documentation for technical processes and ensure compliance with GMP standards while collaborating with cross-functional teams.

BiopharmaBiotechnologyManufacturingPharmaceutical

Responsibilities

Develop, author, and maintain a wide variety of technical documents, including but not limited to Process Flow Diagrams, Summary Reports, Process FMEAs, Master Batch Records, Bill of Materials, and Processing Forms, ensuring that the information is clear, detailed, and usable by both technical and non-technical stakeholders

Ensure all documentation is compliant with GMP standards and meets regulatory requirements, particularly for Process Performance Qualification and Continuous Process Verification

Work closely with MSAT engineers, project teams, and clients to gather necessary technical information, facilitate effective communication, and ensure that all documentation reflects the latest process developments and changes

Translate technical data and process monitoring results into comprehensible reports, identifying trends, proposing actions, and supporting troubleshooting efforts with clear, actionable documentation

Establish and maintain documentation standards to ensure consistency across all technical documents. Continuously review and update documents to reflect process improvements, new technologies, and regulatory changes

Create user manuals, training guides, and other support materials to aid in the onboarding and ongoing education of staff regarding GMP manufacturing processes and protocols

Qualification

GMP knowledgeTechnical writingDocumentation toolsProcess validationCollaboration skillsOrganizational skillsAttention to detail

Required

Associate's degree in an English major or in scientific, engineering, or technical discipline (e.g., Biology, Chemistry, Biochemistry, Biotechnology, Engineering)

Minimum of 0 - 3 years of experience in technical writing within a GMP environment, preferably in the pharmaceutical, biopharmaceutical, or biotechnology industries

Ensure all documentation is compliant with GMP standards and meets regulatory requirements, particularly for Process Performance Qualification and Continuous Process Verification

Work closely with MSAT engineers, project teams, and clients to gather necessary technical information

Translate technical data and process monitoring results into comprehensible reports

Establish and maintain documentation standards to ensure consistency across all technical documents

Create user manuals, training guides, and other support materials to aid in the onboarding and ongoing education of staff regarding GMP manufacturing processes and protocols

Preferred

A bachelor's degree is preferred

Proficient in writing clear, concise, and accurate technical documentation

Strong understanding of GMP manufacturing processes and regulatory requirements

Excellent organizational skills with high attention to detail

Ability to collaborate effectively with cross-functional teams and communicate complex information to diverse audiences

Familiarity with documentation tools and electronic document management systems (EDMS)

Ability to manage multiple projects and deadlines simultaneously

Company

INCOG BioPharma Services

Our services include injectable drug product formulation development, analytical method development, process scale up, and formulation & filling of vials, syringes and cartridges.

Founded in 2020

Fishers, Indiana, USA

201-500 employees