Qualification Engineer

Leiden
4000.00 - 6500.00
32-40 uren
1 year, contract to hire with client
Bachelor degree

Opdrachtgever

Our client is a leading Project Management and Engineering company serving the pharmaceuticals industry.

functie Vereisten

Bachelor’s degree or equivalent degree in Engineering (Chemical, Mechanical, or Industrial) or other scientific field, required.
Minimum 4 years of proven experience in the (bio)pharmaceutical industry or related academic experience or education is required.
Minimum 2 years of proven experience working in a commissioning, qualification, validation (CQV) role.
Familiar with regulations (ICH, EMA, CFR) and industry standard (ISPE, PDA)
Accurate, structured, flexible and customer focused;
Good communication skills in English (both oral and written);
Experience with cGMP inspections, process excellence and project management is an advantage.

Wat krijg je?

Pension entitlement (15.9% employer contribution, 7.5% employee contribution)
Collective WGA / WIA insurance
NBBU collective labour agreement through equal remuneration
25 holidays days
8% holiday allowance
100% payment in case of illness in the first year
Travel allowance per kilometer or through public transport

Werkzaamheden

As a Qualification Engineer, you will lead the validation and qualification efforts for critical manufacturing systems and equipment, ensuring that processes align with stringentregulatory standards and industry best practices. Your role will include planning, oversight, and troubleshooting of commissioning, qualification, and validation activities.

Support the commissioning process for new or upgraded systems, ensuring proper installation and functionality.
Develop qualification plans for highly complex projects based on user requirements, regulatory guidelines, and company standards.
Execute Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) protocols in collaboration with cross-functionalteams.
Conduct risk assessments related to the commissioning and qualification activities, identifying and mitigating potential risks.
Generate and maintain comprehensive documentation, including test scripts, reports, and validation protocols, ensuring compliance with regulatoryrequirements.
Participate in change control processes, assessing the impact of changes on validated systems.
Collaborate with engineering, quality assurance, and production teams to ensure detailed integration of new systems and modifications.
Identify and resolve issues related to equipment, systems, or processes during the commissioning and qualification phases.
Contribute to continuous improvement initiatives by recommending enhancements to commissioning and qualification processes.