Engineering Technical Writer

Engineering Technical Writer

WHO?

We are looking for an Engineering Technical Writer who is a detail-oriented documentation professional with a strong technical background and a thorough understanding of GMP documentation standards. Embedded within INCOG BioPharma’s Engineering and Technical Operations team, the Engineering Technical Writer is the primary owner of engineering documentation quality, consistency, and compliance.

WHAT?

• Author, revise, and maintain engineering GMP documentation (SOPs, work instructions, prep forms, IQ/OQ/PQ protocols/reports, validation documents, engineering specs, and functional design documents) in accordance with cGMP and INCOG standards, collaborating with Production Engineers, Process Engineers, Manufacturing Equipment Technicians, and 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 coordinated with Quality, Manufacturing, and Engineering 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 engineering training materials, job aids, and visual work instructions to support competency development across PrE, PE, and MET teams

YOU!

• 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.

Why INCOG?

• Paid time off, based on tenure
• 11 paid holidays
• 401(k) plan with company match up, vested immediately
• Choice of health & wellness plans
• FSA and HSA options
• Onsite wellness facility
• Employee engagement activities; food trucks, monthly luncheons, fundraising events, team building competitions, offsite celebrations

Don’t meet all the requirements? Don’t sweat! We’re always looking for an excuse to discuss your next opportunity. You might just surprise yourself…

Lead Candidate wholeheartedly supports Equality and Diversity in employment and opposes all forms of unlawful or unfair discrimination on the grounds of age, disability, sex, gender reassignment, sexual orientation, pregnancy and maternity, race, religion or belief and marriage and civil partnerships.