Injection Molding Process Engineer

Formulatrix; Tangerang; Híbrido; IDR 600.000.000 - 1.000.000.000; Jornada completa

Descripción de la vacante

Formulatrix is seeking a Process Engineer for pharmaceutical manufacturing in Tangerang, Indonesia. The role blends onsite collaboration with focused remote work in a hybrid setup to optimize manufacturing processes while ensuring GMP compliance and product quality.

The candidate will drive process validation, scale-up, data analysis, and technology transfer with R&D, QA, and Production teams, contributing to efficient operations in a regulated environment.

Formación

• Bachelor's or Master's in Chemical Engineering or related field.
• 5+ years of process engineering experience in pharma/biotech.
• Thorough GMP knowledge and validation principles.
• Experience with process simulation and data analysis software.
• Strong analytical and problem-solving skills.

Responsabilidades

• Optimize and troubleshoot pharmaceutical manufacturing processes, including synthesis and purification.
• Ensure compliance with GMP and regulatory requirements for all processes.
• Develop and execute process validation protocols and reports.
• Collaborate with R&D, Quality Assurance, and Production for tech transfer.
• Analyze process data to identify trends and improvements.
• Design process improvements to increase efficiency, yield and quality.
• Prepare batch records, SOPs, and equipment specifications.
• Support CAPAs and investigations of deviations.
• Stay current with industry best practices in pharmaceutical manufacturing.

Conocimientos

Chemical Engineering

GMP compliance

Process optimization

Data analysis

Cross-functional collaboration

Educación

Bachelor's or Master's degree in Chemical Engineering

Herramientas

Process simulation software

Descripción del empleo

Process Engineer - Pharmaceutical Manufacturing

Our client, a leading pharmaceutical company renowned for its commitment to quality and innovation, is seeking a skilled Process Engineer to join their dynamic team in Tangerang . This role operates on a hybrid model, fostering collaboration within the manufacturing facility while allowing for focused remote work. You will play a crucial role in optimizing manufacturing processes, ensuring product quality, and driving operational efficiency within a highly regulated environment. This position requires a strong understanding of chemical engineering principles applied to pharmaceutical production, including process validation, scale-up, and GMP compliance. Our client is dedicated to advancing healthcare through cutting‑edge drug development and manufacturing, offering a challenging and rewarding career path.

About the Role

Our client, a leading pharmaceutical company renowned for its commitment to quality and innovation, is seeking a skilled Process Engineer to join their dynamic team in Tangerang . This role operates on a hybrid model, fostering collaboration within the manufacturing facility while allowing for focused remote work. You will play a crucial role in optimizing manufacturing processes, ensuring product quality, and driving operational efficiency within a highly regulated environment. This position requires a strong understanding of chemical engineering principles applied to pharmaceutical production, including process validation, scale-up, and GMP compliance. Our client is dedicated to advancing healthcare through cutting‑edge drug development and manufacturing, offering a challenging and rewarding career path.

Key Responsibilities

• Optimize and troubleshoot pharmaceutical manufacturing processes, including synthesis, purification, and formulation steps.
• Ensure all processes comply with Good Manufacturing Practices (GMP) and relevant regulatory requirements.
• Develop and execute process validation protocols and reports.
• Collaborate with R&D, Quality Assurance, and Production teams to facilitate technology transfer and process improvements.
• Analyze process data to identify trends, deviations, and opportunities for enhancement.
• Design and implement process improvements to increase efficiency, reduce costs, and improve product yield and quality.
• Prepare and maintain detailed process documentation, including batch records, SOPs, and equipment specifications.
• Support the investigation of production deviations and implement corrective and preventive actions (CAPAs).
• Stay current with industry best practices and advancements in pharmaceutical manufacturing technology.

Requirements

• Bachelor's or Master's degree in Chemical Engineering or a related field.
• Minimum of 5 years of experience in process engineering within the pharmaceutical or biotechnology industry.
• Thorough understanding of GMP regulations and validation principles.
• Experience with process simulation and data analysis software.
• Strong knowledge of chemical engineering principles relevant to pharmaceutical manufacturing.
• Excellent analytical, problem-solving, and critical thinking skills.
• Effective communication and interpersonal skills, with the ability to collaborate across