Job Description
Would you like to apply your technical expertise at one of the largest industrial players in the Netherlands? Do you enjoy working in a high-tech environment where you make an impact with products that truly matter? Then we are looking for you!
For our department, we are looking for a Senior Validation/Qualification Engineer.
Welcome to our team
You will be part of the validation and calibration team of the technical department, which is responsible for coordinating, executing and reporting validations, qualifications and calibrations for our various locations. We work closely with various departments, such as the integrated process teams, centers of expertise and the Research & Development department.
As a Senior Validation/Qualification Engineer, you are the expert in the field of validation, qualification and calibration. You develop and manage validation and qualification protocols and actively contribute to improving our processes. You analyze data, identify improvement opportunities and support them with clear improvement proposals. In doing so, you not only increase productivity, but also safety and quality within our organization.
About the role
In the first year, you are expected to show affinity with the industry and relevant areas of knowledge. This forms the basis for effective collaboration within the team. You contribute to preventing backlogs and ensuring quality.
The goal is to be fully onboarded after one year and able to contribute independently, whereby the team's workload noticeably decreases. Success is assessed on independence and impact on the team.
Distribution of activities:
-
Review of reports (25%)
-
User Requirements Specification input/evaluations (20%)
-
Technical consultation with stakeholders (25%)
-
Improving and safeguarding procedures (20%)
-
Technical input in deviation management (10%)
Stakeholders: suppliers, process owners, direct colleagues and engineering teams.
What will you do?
-
Drafting, reviewing and managing validation, qualification and calibration protocols, including reports and annual plans.
-
Performing data analyses and recording in the CMMS system, with a focus on continuous improvement of processes.
-
Reviewing technical documentation such as qualification and 'as built' reports, and providing support during audits.
-
Acting as a Subject Matter Expert (SME) in the field of qualification and calibration within projects and on compliance matters.
-
Safeguarding knowledge and supporting departments with technical expertise and training.
-
Ensuring compliance with health, safety and environmental policies and relevant laws and regulations.
Your profile
-
Higher vocational (HBO) degree in a technical field and 5–7 years of experience in the pharmaceutical industry.
-
Demonstrable knowledge of GMP and experience with validation and calibration processes.
-
Strong at analyzing technical documents and writing clear reports.
-
Communicative in Dutch and English.
-
Analytically strong, with a customer- and service-oriented attitude.
-
Flexible, proactive and able to work both independently and in a team.
What we offer
Working at our organization means working together on health in an international work environment with dedicated colleagues. You will have every opportunity to develop yourself and show who you are. Furthermore, you can count on attractive employment conditions, such as:
-
A competitive salary.
-
35.5 vacation days.
-
8% holiday allowance and 3% year-end bonus.
-
Bonus scheme.
-
An excellent pension.
-
Various training modules and growth opportunities.
Do you have questions about this vacancy?
Send your question including the vacancy number and the vacancy title to the following email address: [email protected]. Applications can only be submitted via the website.
Additional location(s) Compensation Information:
Required Skills:
Calibration of Equipment, Computerized Maintenance Management Systems (CMMS), Process Instrumentation, Protective Security, R&D Engineering
Preferred Skills:
Current Employees apply HERE
Current Contingent Workers apply HERE
Search Firm Representatives Please Read Carefully
Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.
Employee Status:
Regular
Relocation:
VISA Sponsorship:
Travel Requirements:
Flexible Work Arrangements:
Not Applicable
Shift:
Valid Driving License:
Hazardous Material(s):
Job Posting End Date:
01/5/2027
*A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.
