Technical Writer – Deviations (Life Sciences)

About the role

The Technical Writer will support Antaes Asia’s life‑science projects by investigating manufacturing deviations and producing rigorous documentation that meets regulatory standards. You will work closely with engineering, quality and production teams to ensure deviations are analysed, resolved and prevented.

Key responsibilities

• Lead complex investigations into manufacturing deviations, non‑conformances and environmental excursions.
• Apply structured Root Cause Analysis tools such as Fishbone, 5 Whys and FMEA to uncover underlying triggers.
• Author comprehensive investigation reports that satisfy internal and external audits (FDA, EMA, etc.).
• Perform impact assessments on product quality, safety and efficacy.
• Design and implement Corrective and Preventive Actions (CAPAs) and monitor their effectiveness with data‑driven metrics.
• Identify trends in manufacturing data to propose process improvements and “Right First Time” initiatives.
• Provide real‑time engineering floor support for equipment malfunctions or process drift.
• Collaborate with QA and Production to ensure activities align with SOPs.
• Draft and revise SOPs, batch records and validation protocols.
• Assist in promoting Antaes services to clients.

Required profile

• Bachelor’s degree in Science, Chemical, Mechanical or Manufacturing Engineering, Biotechnology or a related life‑science field.
• Minimum 2 years of experience in engineering or the pharmaceutical industry.
• Strong understanding of cGMP and global regulatory standards.
• Ability to work independently and as part of a multidisciplinary team.
• Excellent organizational, oral and written communication skills.

Required skills

• Root Cause Analysis tools (Fishbone, 5 Whys, FMEA).
• CAPA design and effectiveness monitoring.
• Data‑driven trend analysis of manufacturing processes.
• Process flow diagram creation and technical illustration.
• Instructional design for SOPs and training materials.
• Lean Manufacturing and Six Sigma principles.
• Digital documentation tools and content management systems (TrackWise, VeevaVault).
• Advanced technical writing and documentation skills.