Validation Technician II
eTeam UK
Haarlem, NL
4 dagen geleden

Temp vacancy for 3-6 months depending on perm recruitment

Looking for someone with 5+ years experience in process validation, reporting and reviewing.

32-40 hours / per week if the candidate is very suitable 24 hours also possible.

Job Description

You will carry out risk assessment, and prepare validation plans, protocols, execution of experiments and reporting of the work.

Participate in the execution of the respective validation activities, evaluate the results and prepare reports from them.

Within the MS&T (Manufacturing Science and Technology) department we are looking for a Process Validation and Improvement Expert.

You are a subject matter expert, responsible for planning and execution of process / cleaning validations, media fills, line / operator qualification, as well as process improvement and product robustness initiatives.

You will work in dynamic project teams responsible for new project introductions, process improvements and remediations to meet current regulatory requirements, and will ensure that the executions are in line with international and global guidelines.

You will carry out risk assessment, and prepare validation plans, protocols, execution of experiments and reporting of the work.

Participate in the execution of the respective validation activities, evaluate the results and prepare reports from them.

You are part of operational excellence and product robustness teams, responsible for critical assessment of processes and design of improvement plans, continued process verification.

Keep up-to-date with regulatory guidelines on process validation requirements.

In addition, you take part in many other activities required for optimal quality of validation activities.

Qualifications

MSc in bioprocess engineering / technology, pharmacy, chemistry or similar

At least 2 years' experience in a cGMP environment

Experience with process improvement / validation or quality assurance

Working knowledge of FDA / EU GMP guidelines

Good command of the English language

Team player with pro-active approach. This is a dynamic challenging position with possibilities for growth within our company.

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