Validation Technical Writer

INCOG BioPharma Services; Fishers (IN); On-site; USD 70,000 - 100,000; Full time

Job summary

INCOG BioPharma Services seeks a Validation Technical Writer to own CQV documentation within the Engineering and Technical Operations team. You will craft, revise, and organize GMP documentation, including SOPs, work instructions, and validation lifecycle records, ensuring audit readiness and regulatory compliance.

Preferred candidates have 3+ years of technical writing in regulated environments (or 1 year with validation/engineering exposure).

Qualifications

• Bachelor’s degree in a scientific, engineering, or technical discipline.
• Minimum of 3 years of technical writing experience, preferably in a regulated GMP environment, or 1 year with validation/engineering within the pharmaceutical/biotech industries.
• Strong understanding of GMP processes and regulatory requirements.
• Experience with EDMS and document control processes.

Responsibilities

• Author, revise, and maintain Validation GMP documentation per cGMP and INCOG standards.
• Manage the full document lifecycle in INCOG's DMS, including change control.
• Draft deviation investigations, root cause analyses, and CAPA documentation.
• Develop validation training materials, job aids, and visual work instructions.
• Conduct document gap assessments and periodic reviews for consistency.
• Serve as documentation readiness resource during audits and inspections.
• Support Validation Engineering activities to maintain validated state.
• Work flexible hours to support facility coverage.

Skills

Technical writing

GMP knowledge

Editing

EDMS tools

MS Word

MS Excel

Cross-functional collaboration

Education

Bachelor’s degree in science/engineering

Tools

Veeva

Kneat

Job description

We are looking for a Validation Technical Writer who is a detail-oriented documentation professional with a strong technical background and a thorough understanding of GMP documentation standards in a regulated pharmaceutical manufacturing environment. Embedded within INCOG BioPharma's Engineering and Technical Operations team, the Validation Technical Writer is the primary owner of commissioning, qualification, and validation (CQV) documentation, and validation responsibilities within the Quality Management Systems.

This role partners closely with Validation, Production Engineers, Process Engineers,Manufacturing Equipment Technicians, Quality Assurance, Technical Services, and Operations to translate complex technical content into clear, accurate, and audit-ready documentation. The Validation Technical Writer plays a critical role in ensuring that INCOG's CQV documentation infrastructure supports operational excellence, regulatory readiness, and long-term institutional knowledge across all manufacturing areas and suites.

Essential Job Functions:

• Author, revise, and maintain Validation GMP documentation (SOPs, work instructions, prep forms, and CQV lifecycle documentation) in accordance with cGMP and INCOG standards, collaborating with SMEs to translate technical input into clear, compliant content.
• Manage the full document lifecycle in INCOG's DMS (initiation, periodic review, revision control, approval routing, and retirement), including change control documentation to ensure change packages are complete and inspection ready.
• Structure and draft deviation investigations, root cause analyses, and CAPA documentation, and provide technical writing support for master batch record sections covering equipment setup, cleaning, and operation.
• Develop validation training materials, job aids, and visual work instructions to support competency development across engineering teams.
• Conduct document gap assessments and periodic reviews of validation documentation, applying INCOG's documentation style standards to resolve discrepancies and maintain consistency across engineering documents.
• Serve as a documentation readiness resource during internal/client audits and regulatory inspections, and maintain an organized, traceable documentation library with indices and metadata for efficient retrieval.
• Support additional Validation Engineering activities as needed to maintain the validated state of equipment and systems, and project timelines.
• Work flexible hours to support manufacturing facility coverage as needed.

Special Job Requirements:

• Bachelor’s degree in a scientific, engineering, or technical discipline.
• Minimum of 3 years of technical writing experience, preferably within a regulated GMP environment, or 1 year with direct experience in validation or engineering within the pharmaceutical, biopharmaceutical, or biotechnology industries.

Additional Preferences:

• 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), Veeva and Kneat preferred.
• Exceptional computer skills, particularly moderate to expert level experience with Microsoft Word and Microsoft Excel.
• Ability to manage multiple projects and deadlines simultaneously.

Additional info about INCOG BioPharma Services:

At INCOG BioPharma we have built a world-class CDMO for parenteral injectable drugs. Our culture and priorities are different by design: focused on building long-term value for our customers, we are committed to a service-culture mindset, technical excellence, and a collaborative and team-centered approach to doing business.

If you crave the challenge of creating systems from scratch and believe you have insights for a better way of doing business, which benefits customers by ensuring quality outcomes and accelerating their route to market, we want to hear from you. Unless otherwise specified, all positions are based out of our Fishers, IN offices. Please note, we are a smoke-free campus.

INCOG BioPharma is an Equal Opportunity Employer and prohibits discrimination and harassment of any kind. All employment decisions at INCOG BioPharma are based on business needs, job requirements and individual qualifications, without regard to race, color, religion or belief, sex (including pregnancy), age, physical disability, sexual orientation, family or parental status, or any other status protected by the laws or regulations in the locations where we operate. We will not tolerate discrimination or harassment based on any of these characteristics.

Qualified applicants must be authorized to work in the United States on a full-time basis. INCOG will not provide support for or sponsor work authorization or visas for this role, including but not limited to F-1 CPT, F-1 OPT, F-1 STEM OPT, J-1, H-1B, TN, O-1, E-3, H-1B1, or L-1.

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