Process Engineer - Investigations - Cell Therapy

Oxford Global Resources; Amsterdam; Hybrid; EUR 52,000 - 64,000; Full time

Job summary

Oxford Global Resources in the Netherlands seeks a GMP-focused MSAT Process Engineer to join the MSAT team. You will investigate deviations, perform root-cause analysis, and implement CAPAs to improve quality in a fast-paced, highly regulated environment.

The role collaborates with production, QC, and QA; requires a Bachelor’s degree, experience in GMP settings, and familiarity with GVAULT, Oracle EBS, and LIMS is a plus.

Qualifications

• Bachelor's degree in a relevant field.
• Strong understanding of pharmaceutical processes and GMP-guidelines.
• Experience leading investigations and implementing CAPAs.
• Strong communication skills to collaborate with several departments.
• Experience with GVAULT, Oracle EBS, and LIMS are a big plus.

Responsibilities

• Investigations after deviations
• Continuous improvement
• Root-cause analysis to resolve deviations
• Implementing and managing CAPAs
• Writing reports
• Collaboration with other departments

Skills

Root-cause analysis

CAPA implementation

GMP guidelines

Investigation leadership

Communication skills

Education

Bachelor's degree in a relevant field

Tools

GVAULT

Oracle EBS

LIMS

Job description

In this role, you focus on investigations after deviations to continuously improve the quality at this modern biotech firm. Apply today if you are interested in root-cause analysis, continuous improvement, and implementing changes.

Job description

You are part of a leading biotech firm and in the MSAT team as a process engineer. Whenever something goes wrong, you and your team are consulted to dive into the issue and provide a solution. This typically is an investigation or root-cause analysis after a deviation, followed by CAPA-implementation and management. With the continuous improvement mindset, you also pro-actively review SOPs and GMP-records and rewrite these if needed to decrease the chances of mistakes or deviations. Given the nature of the work, you collaborate with production, QC, and QA extensively. We are looking for someone with at a few years of relevant experience in a GMP-environment, leading investigations and (re)writing GMP-documents. The work in this department is fast-paced and non-routine in a highly-regulated environment.

Responsibilities

• Investigations after deviations
• Continuous improvement
• Root-cause analysis to resolve deviations
• Implementing and managing CAPAs
• Writing reports
• Collaboration with other departments

Profile

• Bachelor's degree in a relevant field
• Strong understanding of pharmaceutical processes and GMP-guidelines
• Experience leading investigations and implementing CAPAs
• Strong communication skills to collaborate with several departments
• Experience with GVAULT, Oracle EBS, and LIMS are a big plus

Practical information and Benefits

• Fulltime position - 40 hours per week.
• Up to two days remote, at least three on site
• Salary: €58230,- annually
• Travel costs reimbursed
• 28 holiday days per year
• Location: Hoofddorp
• Vacaturenummer: 27436