Deviation Writer

INCOG Bio Pharma Services is seeking an experienced and detail-oriented Deviation Writer to join our Manufacturing Engineering team. This role is crucial for translating a variety of complex technical events into clear, accurate, and robust investigations. The Deviation Writer will work closely with Manufacturing, Production Engineering, Manufacturing Sciences and Technology, Supply Chain, Quality, and other cross‑functional teams to create comprehensive investigations that leverage facts and data to support robust root‑cause conclusions, effective corrective actions, and systematic preventative actions.

The Deviation Writer will exemplify excellent interpersonal skills and be capable of developing productive customer‑centric working relationships with internal and external customers, while maintaining a role with high visibility to all departments. The position requires strong familiarity with industry standard electronic Quality Management System(s) and Microsoft Office suite products. The successful candidate will thrive working autonomously, yet also be able to collaborate and lead within a team environment, valuing the processes owned by internal customers and subject matter experts.

• Understand, investigate, and author a variety of deviating conditions or nonconforming events across multiple technical departments, in alignment with Subject Matter Experts.
• Self‑motivated to gather facts, analyze information, interpret data, and utilize expertise from Subject Matter Experts to provide supporting evidence to the investigation and root cause.
• Utilize a variety of analysis tools such as Ishikawa Fishbone, 5 Why, etc., to support root‑cause identification.
• Think critically outside the box to develop robust corrective and preventative actions, leveraging automation and engineering controls to error‑proof equipment and processes.
• Translate complex, technical processes and descriptions into simplified, understandable write‑ups.
• Eager to collaborate and partner with internal and external stakeholders to comprehensively represent the facts of an investigation in a logical and presentable manner.
• Evaluate historical deviating conditions, adverse events, and non‑conformances to identify trends and prevent future occurrences.

• Bachelor’s degree in a scientific, engineering, or technical discipline.
• Minimum of 3 years of experience in technical writing within a regulated GMP environment, preferably in 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).
• Exceptional computer skills, particularly moderate to expert level experience with Microsoft Word and Microsoft Excel.

At INCOG Bio Pharma 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 Bio Pharma is an Equal Opportunity Employer and prohibits discrimination and harassment of any kind. All employment decisions at INCOG Bio Pharma 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.