Commissioning & Qualification Equipment Engineer | Pharma | Beerse

Select Human Resources NV; Belgique; Remote; EUR 65,000 - 90,000; Full time

Benefits offered by this job

Elektrische bedrijfswagen

Maaltijdvergoeding

Reiskostenvergoeding

Groepsverzekering & hospitalisatie

12 extra verlofdagen

Eindejaarsbonus

Holiday pay

Job summary

Select Projects zoekt een Commissioning & Qualification Equipment Engineer die kwalificatiedocumentatie voorbereidt, onderhoudt en uitvoert voor GMP-kritische apparatuur, utilities en systemen. Je werkt samen met C&Q Leads, SMEs en projectteams doorheen initiatie tot oplevering.

Je verzorgt ook qualificatietests en follow-up activiteiten en draagt bij aan het behoud van gevalideerde en conforme systemen. Een sterke aandacht voor detail en schriftelijke communicatie zijn essentieel in een

Qualifications

• Bachelor- of Masterdiploma in een wetenschappelijke of technische richting.
• Goede schriftelijke en mondelinge communicatie in het Nederlands en Engels.
• Sterke technische schrijf- en documentatievaardigheden.
• Ervaring met engineering-systemen, utilities of productie-apparatuur is een pluspunt.
• Gestructureerd, kwaliteitsgericht en zelfstandig werken in GMP-omgeving.

Responsibilities

• Opstellen, onderhouden en uitvoeren van qualificatiedocumentatie (URS, SRS, IA, DQ, IQ, OQ, PQ, QRP en Validation Master Plans).
• Uitvoeren en documenteren van qualificatietests voor apparatuur, utilities en systemen.
• Coördineren review- en handtekeningenprocessen en opvolgen van punch-list items.
• Ondersteunen van interne en externe audits en inspecties.
• Archiveren van documenten conform GMP/GDP vereisten.

Skills

Dutch & English

Technical writing

Stakeholder communicatie

Team samenwerking

Education

Wetenschappelijke/technische opleiding

Job description

FunctieomschrijvingAs a **Commissioning & Qualification Equipment Engineer**, you are responsible for preparing, maintaining and executing qualification documentation for GMP-critical equipment, utilities and systems. You ensure that all documentation complies with applicable **GMP requirements** and internal quality standards. You work closely with C&Q Leads, Subject Matter Experts and project teams to support qualification projects from initiation through completion. Besides document preparation, you also participate in qualification testing and follow-up activities. Your work plays an important role in ensuring that systems remain in a validated and compliant state.### Fortunately, we can count on you for:* Writing **qualification documentation** including URS, SRS, IA, DQ, IQ, OQ, PQ, QSR and Validation Master Plans* Executing and documenting **qualification tests** for equipment, utilities and systems* Assessing the impact of changes, deviations and discrepancies on qualification activities* Coordinating document reviews, approval flows and signature processes* Following up punch list items and qualification actions until closure* Supporting internal and external audits and inspections* Managing document archiving in accordance with **GMP** and **GDP requirements**ProfielYou are structured, quality-minded and eager to learn. You communicate effectively with different stakeholders and enjoy working in a team-oriented GMP environment. At the same time, you are capable of independently managing documentation and qualification activities.What you bring* Bachelor's or Master's degree in a **scientific or technical field** such as Industrial Engineering, Biochemistry, Biotechnology or Pharmaceutical Sciences* Strong interest in the **pharmaceutical industry** and GMP-regulated environments* Excellent **technical writing** and documentation skills* Experience with engineering systems, utilities or manufacturing equipment is an asset* Fluent in **Dutch and English**, both written and spokenOrganisatie- en afdelingomschrijvingAt **Select Projects**, the experience our clients have with our consultants is what matters most. Our consultants create that experience by delivering the highest quality in everything they do. Your expertise is central to this, and at **Select Projects** you will have the opportunity to keep growing so you can become and deliver the best version of yourself. As a consultant, you bring knowledge, skills and the drive to succeed. What do you get in return? **Select Projects** offers technically challenging projects, career growth opportunities, autonomy, trust, training and knowledgeable colleagues who are happy to share their expertise. This allows you to continuously develop both professionally and personally. At **Select Projects**, you are not only part of the client's team. Together with your fellow consultants in the field, you are also part of our team. We value a family-oriented culture where people genuinely help and support each other. This enables you to become and deliver the best version of yourself. Working at **Select Projects** means continuously developing your craftsmanship and becoming a true specialist in your field.AanbodAt Select Projects, we make sure you join a **pleasant working environment** where great colleagues and team spirit are at the heart of everything we do. We regularly organize after-work events, company parties, sports activities and team-building initiatives. We also offer plenty of opportunities for you to grow and develop. Together, we create a **personalized training plan** tailored to your ambitions, future goals and development needs. At Select Projects, you can become and deliver the best version of yourself. In addition, Select Projects offers you a **permanent contract** with an **attractive salary package**, including the following benefits:* **Electric company car** with charging card* Meal vouchers & eco vouchers* Expense allowance* Group insurance & hospitalization insurance* **12 additional leave days (ADV)** per year* End-of-year bonus* Single and double **holiday pay*** Bonus system including both collective and individual bonuses* Opportunity to participate in the **Flex Income Plan** program