Analytical Lab Equipment CQV Engineer
- Leiden
- 4000.00 - 5500.00
- 32-40 hours
- Bachelor degree
Client
Our client is a nationally operating service provider that advises its customers on, designs, builds and maintains industrial processes.
Client
Our client is a nationally operating service provider that advises its customers on, designs, builds and maintains industrial processes.
The organisation is characterised by an informal, flexible working environment with short lines of communication, where atmosphere and collegiality are of paramount importance. In addition, there is room and guidance for your personal and professional development through education and training.
Requirements
- Bachelor's or master's degree in a Life Sciences-oriented program or equivalent through experience.
- We are looking for colleagues with at least 2 years of experience as an AIQ engineer within the pharmaceutical industry, but also for highly experienced profiles with more than 7 years of experience.
- Knowledge of relevant regulations and standards (GMP, GAMP5, FDA, Pharmacopeia).
- Strong problem-solving skills and the ability to work accurately and in a structured manner.
- Good communication skills, both written and verbal, in Dutch and English.
- Proactive attitude and ability to work independently and take responsibility for your own projects.
- Knowledge of data integrity is a plus.
What do you get?
- Pension entitlement as from day one
- Collective WGA / WIA insurance
- NBBU / ABU collective labor agreement
- 25 holidays days
- 8,33% holiday allowance
- 100% payment in case of illness after one waiting day
- Travel allowance
Duties
As an analytical instrument qualification (AIQ) consultant, you are responsible for validating and qualifying laboratory equipment within a GMP-controlled environment. You work closely with colleagues and our client to ensure that all lab equipment and systems comply with applicable regulations and guidelines.You will work with clients to ensure the safety of patients and consumers.
- Writing and executing test and validation protocols (IQ, OQ, PQ) for a wide variety of equipment related to the QC lab (e.g., HPLC, PCR, IR, MALDI-TOF, balances, pipettes, flow cytometers, etc.).
- Assessing technical documentation for laboratory equipment.
- Coordinating installation with internal and external parties.
- Analyzing test results and preparing validation reports.
- Assisting with audits and inspections by providing relevant documentation.
- Supporting the preparation and implementation of change controls and document management.
- Preparing risk analyses and impact assessments.
- Maintaining and improving standard operating procedures (SOPs).
- Ensuring compliance with GMP and other relevant standards and guidelines.
