Deviation Writer - Engineering

INCOG Bio Pharma Services is seeking an experienced and detail-oriented Deviation Writer to join our team. This role translates complex technical events into clear, accurate investigations, working closely with Manufacturing, Production Engineering, Manufacturing Sciences and Technology, Supply Chain, Quality, and other cross-functional teams to support robust root cause conclusions, corrective actions, and preventative actions.

The Deviation Writer thrives working autonomously, while also collaborating and leading within a team environment, valuing processes owned by internal customers and subject matter experts to influence positive outcomes.

• 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 fact‑gather, analyze information, interpret data, and utilize expertise from Subject Matter Experts to provide supportive evidence for investigations and root cause.
• Experience utilizing a variety of analysis tools to support root cause identification;
  Ishikawa Fishbone, 5 Why, etc.
• Ability to think critically outside the box for robust corrective and preventative actions, leveraging automation and engineering controls to error‑proof equipment and processes.
• Demonstrated ability to translate complex, technical processes and descriptions into simplified, understandable write‑ups.
• Eagerness to collaborate and partner with both internal and external stakeholders to comprehensively represent the facts of an investigation in a logical and presentable manner.
• Evaluating historical deviating conditions, adverse events, non‑conformances, etc. to identify and prevent trends.

• 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.
• Ability to manage multiple projects and deadlines simultaneously.

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.

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.

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.