Technical Specialist
Date Posted: September 4, 2026
Job Description
Key Responsibilities
Operational Readiness
- Support technology transfers and manufacturing process campaigns by developing and updating batch production records, change requests, and operational documentation
- Conduct operational risk assessments
- Facilitate pre-campaign training sessions
- Ensure all readiness tasks are completed before campaign startup
Operational Run
- Support evaluation of manufacturing deviations through the Deviation Review Board process
- Manage CAPAs (Corrective and Preventive Actions)
- Manage Change Control System Requests
- Manage rejected material processes and related campaign tasks
- Participate in audits and quality reviews related to manufacturing processes and deviations
Operational Release
- Lead technical deviation investigations and trend analyses to identify root causes using structured problem-solving methodologies
- Conduct product impact assessments
- Design effective CAPAs to support timely disposition and release of manufactured lots
Required Qualifications and Skills
- Strong understanding of biopharmaceutical/pharmaceutical manufacturing processes
- Hands-on operational knowledge of manufacturing equipment
- Proven experience in technical writing
- Experience in root cause analysis (RCA)
- Experience managing Quality Management System (QMS) elements, including deviations, CAPAs, and change controls
- Excellent verbal communication and presentation skills
- Strong adaptability and agility in managing shifting deliverables and dynamic operational priorities
If you are keen to grow your career with this job, apply with us and send us your resume now. All shortlisted candidates will be contacted shortly.
Reference no.: 122-4948-2918-NW
Registration no.: 968446516E