Aseptic Processing Associate

SIRE LIFE SCIENCES; Hoofddorp; On-site; EUR 55,000 - 75,000; Full time

Job summary

SIRE LIFE SCIENCES in the Netherlands is seeking a hands-on manufacturing specialist to support clinical and commercial cell therapy production in a GMP environment. You will join either the Production Team or Production Support Team after training and work under strict SOPs and quality controls.

The role involves aseptic processing, batch record completion, material handling, cleanroom operations, cryopreservation, and collaboration with QA, QC, and supply teams to ensure compliant product

Qualifications

• MLO, MBO, or HBO qualification with Life Sciences background.
• Experience in pharmaceutical/biotech manufacturing environment.
• Proven knowledge of biotech/pharma manufacturing processes.
• Strong understanding of cGMP regulations and compliance.
• Experience working in controlled cleanroom environments.
• Ability to work aseptically and follow gowning procedures.
• Strong troubleshooting and problem solving abilities.

Responsibilities

• Perform apheresis accession and transfer to manufacturing areas
• Complete batch records according to SOPs and GMP requirements
• Support batch documentation review for product release activities
• Supply manufacturing suites with required materials and components
• Transfer batch records and documentation into cleanroom environments
• Conduct final product visual inspections
• Perform cryopreservation of excess cells and final product
• Submit manufacturing samples to Quality Control
• Manufacture clinical and commercial products in Grade A and Grade B cleanroom environments
• Complete manufacturing batch records accurately and compliantly
• Draft and revise batch records, SOPs, and work instructions
• Support deviation investigations and corrective actions
• Participate in change management implementation
• Troubleshoot processing and equipment related issues
• Collaborate with Production Support, Product Sciences, Materials Management, Quality Assurance, and Quality Control teams

Skills

Biotech manufacturing

cGMP knowledge

Troubleshooting

Life sciences comms

Education

MLO/MBO/HBO Life Sciences

Job description

The Company

A leading organization in the biotechnology and advanced cell therapy sector focused on developing and manufacturing innovative treatments. The company operates in a highly regulated GMP environment with a strong emphasis on quality, patient safety, process excellence, and continuous improvement.

Role Description

This position supports the manufacturing of clinical and commercial cell therapy products within a GMP regulated environment. Successful candidates will be assigned to either the Production Team or Production Support Team after completing initial training requirements. The role requires hands on manufacturing activities, strict adherence to SOPs and GMP standards, and close collaboration with multiple operational and quality functions.

Responsibilities

• - Perform apheresis accession and transfer to manufacturing areas
• - Complete batch records according to SOPs and GMP requirements
• - Support batch documentation review for product release activities
• - Supply manufacturing suites with required materials and components
• - Transfer batch records and documentation into cleanroom environments
• - Conduct final product visual inspections
• - Perform cryopreservation of excess cells and final product
• - Submit manufacturing samples to Quality Control
• - Manufacture clinical and commercial products in Grade A and Grade B cleanroom environments
• - Complete manufacturing batch records accurately and compliantly
• - Draft and revise batch records, SOPs, and work instructions
• - Support deviation investigations and corrective actions
• - Participate in change management implementation
• - Troubleshoot processing and equipment related issues
• - Collaborate with Production Support, Product Sciences, Materials Management, Quality Assurance, and Quality Control teams

Requirements

• - MLO, MBO, or HBO qualification with a Life Sciences background
• - Experience working within a pharmaceutical, biotechnology, or related manufacturing environment
• - Proven knowledge of biotechnology or pharmaceutical manufacturing processes
• - Strong understanding of cGMP regulations and compliance requirements
• - Experience working within controlled cleanroom environments
• - Ability to work aseptically and follow strict gowning procedures
• - Strong troubleshooting and problem solving abilities