Manufacturing Specialist

NES Fircroft; Amsterdam; On-site; EUR 45,000 - 60,000; Full time

Job summary

NES Fircroft is seeking a dedicated candidate for a manufacturing role in Amsterdam, Netherlands. Responsibilities include executing GMP runs, troubleshooting equipment issues, and collaborating across teams in the clinical and commercial production of pharmaceuticals. Candidates should have a background in Life Sciences, experience in cGMP environments, and comfort with aseptic processes. The role requires a hands-on approach and offers shifts that may include mornings, evenings, and weekends.

Qualifications

• Experience in cGMP in a pharmaceutical or biotechnology manufacturing environment required.
• Comfortable working in full gowning requirements in an aseptic environment.
• Familiarity with Vapro A and B or LITOP A and B is a plus.

Responsibilities

• Manufacturing clinical and commercial products according to SOPs.
• Collaborate with Production Support Teams for GMP runs.
• Troubleshoot processing and equipment issues.

Skills

Hands-on, can-do mentality

Knowledge of pharmaceutical manufacturing

Data analysis skills

Education

MLO/MBO/HBO with a background in Life Sciences

Tools

Microsoft Word

Microsoft Excel

Job description

Attendance: on-site (with shifts: more information at the bottom)

Main Responsibilities

• To perform all tasks associated with the manufacturing of clinical and commercial products in A and B grade areas following batch records and standard operating procedures (SOPs)
• To work as part of a dedicated and committed team to execute GMP runs in close collaboration with Production Support Teams, Product Sciences, Material Management, and Quality Assurance & Quality Control
• Draft new and revise existing manufacturing Batch records / SOP’s / WI’s to support process improvements and maintain GMP compliance as required
• Assist in investigations required to manage deviations
• Contribute to successful change management implementation
• To successfully troubleshoot processing and equipment issues
• To strictly comply with SOPs and cGMP regulations; accurately complete documentation associated with clinical and commercial manufacturing
• To ensure a consistent process execution to guarantee high-quality output
• To maintain cleanroom ‘nest’ in an optimal state
• To continuously look for improvements to the processes to increase quality and efficiency

Your profile

The ideal candidates for this position, in combination with skills and knowledge, should also have a ‘hands-on, can-do’ mentality. You must also be comfortable with working in full gowning requirements in a completely aseptic environment.

• MLO/MBO/HBO (MBO Level +) with a background in Life Sciences
• Vapro A and B, or LITOP A and B are considered a plus
• cGMP experience in a pharmaceutical / biotechnology or similar manufacturing environment is required
• Must have demonstrated knowledge of pharmaceutical manufacturing of biotechnology products
• Skilled in Microsoft Word, Excel, and data analysis

SHIFT SCHEDULE: morning and evening shifts (latest until midnight), including weekends on rotation