Compliance Engineer | RBA (risk based approach) | Beerse
The vacancy in brief
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Job description
As a compliance engineer, you will be part of a multidisciplinary project team responsible for the execution of a Risk Based Remediation project within a GMP?regulated pharmaceutical environment. You will actively contribute to reviewing, adapting, and executing commissioning & qualification activities based on a risk?based approach, in line with applicable regulations and quality standards.
You will work closely with Engineering, Quality Assurance, Operations, and external partners to ensure systems, utilities, and equipment are compliant or re?qualified using a pragmatic, risk?driven methodology.
Key Responsibilities:
- Execute and support Commissioning & Qualification activities (IQ, OQ, PQ) using a Risk Based approach
- Review and assess existing qualification documentation as part of remediation activities
- Author, update, and execute C&Q documentation (protocols, reports, traceability matrices)
- Perform and document risk analyses (e.g. FMEA, impact assessments) to support risk?based decisions
- Support internal and external audits and inspections
- Contribute actively to continuous improvement of C&Q processes and methodologies
- Communicate project progress, risks, and issues to stakeholders
Your profile
Education & Background
- Bachelor’s or Master’s degree in Engineering, Life Sciences, Biotechnology, Chemistry, or a related field
- Relevant experience within a GMP?regulated environment (pharmaceutical, biotech, or medical devices)
Experience
- Several years of experience as a C&Q Engineer
- Proven experience with Risk Based C&Q and/or Risk Based Remediation projects
- Experience qualifying equipment, utilities, and/or systems
Knowledge & Skills
- Strong knowledge of GMP regulations, guidelines, and C&Q principles
- Solid risk assessment and pragmatic decision?making skills
- Experienced in writing and reviewing technical and quality documentation
- Strong communication skills and ability to align with multiple stakeholders
Languages
- Fluent in English (Dutch is a plus, but not mandatory)
Amori Verhaegen
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Annick Mevensen
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Bram Damen
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Julien De Cleene
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Kristoffel Bevernage
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Lesley Verdonck
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Lore Voet
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Marlies Collart
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Priscilla Verjans
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Rik Geijsels
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Sakina El Kasmioui
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Sara Church Chair
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Yves De Mey
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Our five pillars for
a fruitful career
Strong focus on your growth
People-oriented culture
Opportunities to make an impact
Flexibility and customisation
Access to a wide network
Offer
We offer you ample opportunities to grow and further develop yourself. Together with you, we create a personalized training and development plan tailored to your future ambitions and needs. At Select Projects, you are enabled to become — and give — the very best version of yourself.
In addition, Select Projects offers you a permanent contract.
You will receive an attractive salary package, including the following fringe benefits:
- Company car (electric) with fuel card
- Meal vouchers & eco vouchers
- Expense allowance
- Group and hospitalization insurance
- 12 ADV days per year
- End-of-year bonus
- Single and double holiday pay
- Bonus system: collective bonus and individual bonus
- Possibility to participate in a Flex Income Plan
A new job
in 6 steps
01
Applying online
You send your CV via our website or respond to a vacancy that appeals to you. We will review your profile with attention and discretion.
02
Technical (pre)screening
We will contact you within days for a brief introductory interview by telephone. This is how we sound out your expectations, motivation and availability.
03
Personal interview
We will go deeper into your experience, ambitions and interests in a personal interview. We will also tell you more about Select Projects and how you fit in with us.
04
Introduction to our client
If all is well, we will be happy to introduce you to our client. During an interview, you will get to know the team, the working environment and the project in more detail.
05
Pay proposal
Are you and the client enthusiastic? Then we will make a tailor-made proposal tailored to your profile and expectations.
06
You start at Select Projects
If all is well, we will be happy to introduce you to our client. During an interview, you will get to know the team, the working environment and the project in more detail.
