Validation Technical Writer

About the role

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.

Responsibilities

• 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.

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.

Skills

• 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.

About INCOG BioPharma

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.

All positions are based out of our Fishers, IN offices. INCOG BioPharma is a smoke-free campus and an Equal Opportunity Employer.

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.