Biochemical Process Engineer (GMP & Validation)

SUNNINGDALE TECH LTD.; Singapore; Presencial; SGD 52.000 - 78.000; Jornada completa

Descripción de la vacante

Sunningdale Tech Ltd is a leading manufacturer of precision plastic components with global facilities and strong focus on Automotive/Aerospace, Healthcare, and Tooling. The position supports development, control and improvement of manufacturing processes and qualification activities to ensure quality and efficiency.

Responsibilities include process control, equipment qualification (IQ/OQ/PQ), CAPA, SOP maintenance, and cross-functional collaboration to meet production targets while upholding

Formación

• Diploma or Degree in Biotechnology, Biochemistry, Molecular Biology, Life Sciences, or related disciplines.
• 2-5 years of relevant experience in molecular biology or life sciences manufacturing.
• Hands-on experience with molecular biology techniques including PCR, qRT-PCR, nucleic acid extraction, and assay troubleshooting.
• Knowledge of GMP, ISO 13485, FDA regulations or similar quality systems is advantageous.
• Strong analytical, problem-solving and communication skills.

Responsabilidades

• Support development, control and improvement of manufacturing processes and process parameters.
• Support and execute process qualification and validation, including IQ, OQ and PQ.
• Monitor process control, yield, throughput, downtime and abnormalities; take corrective action.
• Troubleshoot process and equipment issues and support root-cause analysis.
• Prepare SOPs, work instructions and validation records; provide training to production staff.
• Ensure equipment readiness and coordinate maintenance, calibration activities.
• Support new product introduction, process transfer and engineering changes.
• Collaborate with Quality, Maintenance, Planning and Purchasing to resolve issues.

Conocimientos

Molecular biology

Analytical skills

Communication skills

Educación

Biotechnology / Biochemistry / Molecular Biology degree

Herramientas

PCR

qRT-PCR

Nucleic acid extraction

Genotyping analysis

Descripción del empleo

Sunningdale Tech Ltd is a leading manufacturer of precision plastic components with global facilities and strong focus on Automotive/Aerospace, Healthcare, and Tooling. The position supports development, control and improvement of manufacturing processes and qualification activities to ensure quality and efficiency.

Responsibilities include process control, equipment qualification (IQ/OQ/PQ), CAPA, SOP maintenance, and cross-functional collaboration to meet production targets while upholding