Qualification / Validation Engineer for Pharmaceutical Automation

Description:

• Review, adaptation and creation of local procedures based on global SOP’s;
• Organize or contribute to GAP assessments, Risk assessments, Remediation plans;
• Organize or contribute to Change control execution during full project cycle;
• Training of people on the newest procedure updates;
• Documentation compliant to cGMP regulation, incl Annex 11 and 21CFR Part 11.

Your profile:

• Master or equal by experience of 5 years;
• Knowledge of the requirements and evolution of cGMP and motivation to master this field;
• People skills in terms of information gathering, training and managing contractors;
• Solid technical background knowledge on automation systems like: DCS, incl. batch, PI, OPC, ODBC, networks, database systems like Oracle;
• Good English and Dutch proficiency speaking and writing;
• Good attitude towards safety, health, environment.

We offer:

• The space to work independently;
• Flexible workinghours;
• Attractive secondary salary (company car, food vouchers, medical- and group assurance);
• A non-hierarchically company structure with direct communication lines;
• The opportunity to develop your personal- skills and career;
• Courses and traning on the job.