Validation Technical Writer

· 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.

· 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.

By submitting your resume and details, you are declaring that the information is correct and accurate.