Technical Writer (Deviations

ANTAES ASIA PTE. LTD.; Singapore; On-site; SGD 70,000 - 110,000; Full time

Job summary

Antaes Asia PTE. LTD. seeks a detail-oriented engineer to support Life Science projects across client sites in Singapore.

You will lead investigations into manufacturing deviations, environmental excursions, and non-conformances, applying structured RCA tools and drafting comprehensive reports for audits. Collaborating with QA and Production, you will drive CAPAs, track effectiveness, and identify data-driven process improvements to achieve Right First Time results.

Qualifications

• Bachelor degree in Science, Chemical Engineering, Mechanical Engineering, Manufacturing Engineering, Biotechnology, or related Life Science.
• 2 years’ experience in Engineering, pharmaceutical industry.
• Strong understanding of cGMP, and global standards.
• Experience with process flow diagrams, technical illustrations, and instructional design.
• Familiarity with Lean Manufacturing and Six Sigma principles.
• Knowledge of digital documentation tools and content management systems (TrackWise, VeevaVault).
• Strong documentation and technical writing skills.

Responsibilities

• Contribute to Life Science projects for Antaes Asia clients.
• Lead investigations into manufacturing deviations, non-conformances, and environmental excursions.
• Apply RCA tools to identify underlying triggers and root causes.
• Author investigation reports for audits (FDA, EMA, etc.).
• Perform impact assessments on product quality, safety and efficacy.
• Design and implement CAPAs to prevent recurrence of deviations.
• Monitor CAPA effectiveness using data-driven metrics.
• Identify trends in manufacturing data and suggest process improvements (RFT).
• Provide real-time engineering floor support to troubleshoot equipment or process drift.
• Collaborate with QA and Production to ensure SOPs compliance.
• Draft and revise SOPs, Batch Records, and Validation protocols.
• Promote Antaes services in client engagements.

Skills

Root Cause Analysis

cGMP

Process Flow Diagrams

Lean Manufacturing

Six Sigma

Technical Writing

Regulatory Audits

Education

Bachelor's degree in Life Science or related

Tools

TrackWise

VeevaVault

Job description

Job Description

• Contribute to Life Science projects for Antaes Asia clients
• Lead complex technical investigations into manufacturing deviations, non-conformances, and environmental excursions.
• Utilize structured Root Cause Analysis (RCA) tools (e.g., Fishbone, 5 Whys, FMEA) to identify underlying triggers.
• Author comprehensive investigation reports that withstand rigorous internal and external regulatory audits (FDA,EMA, etc.).
• Perform impact assessments on product quality, safety, and efficacy.
• Design and implement Corrective and Preventive Actions (CAPAs) to eliminate recurrence of deviations.
• Monitor the effectiveness of implemented CAPAs through data-driven metrics.
• Identify trends in manufacturing data to proactively suggest process improvements and "Right First Time" (RFT) initiatives.
• Provide real-time engineering floor support to troubleshoot equipment malfunctions or process drift.
• Collaborate with Quality Assurance (QA) and Production teams to ensure all activities align with Standard Operating Procedures (SOPs).
• Participate in the drafting and revision of SOPs, Batch Records, and Validation protocols.
• Contribute to the promotion of Antaes services on top of assistance provided to clients

Job Requirements

• Bachelor degree in Science, Chemical Engineering, Mechanical Engineering, Manufacturing Engineering, Biotechnology, or related Life Science
• 2 years’ experience in Engineering, pharmaceutical industry
• Strong understanding of cGMP, and global standards.
• Experience with process flow diagrams, technical illustrations, and instructional design
• Familiarity with Lean Manufacturing and Six Sigma principles.
• Knowledge of digital documentation tools and content management systems (TrackWise, VeevaVault).
• Strong documentation and technical writing skills.
• Candidate must be highly motivated, be able to work independently as well as in a team and have good organizational and oral and written communication skills