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As a quality assurance consultant you work with customers in the pharmaceutical industry to ensure quality on projects or during routine operations. Depending on your background and your level of experience you give advise on regulatory requirements, facilitate risk assessments and investigations, you assist during regulatory inspections, give training and might even be asked to conduct internal or supplier audits on behalf of our customers.

Needs:

  • good knowledge of cGMP
  • good writing skills in english
  • strong analytical skills, well organized, studious and precise
  • minimum 2 years experience in the pharmaceutical industry is a must
  • master or bachelor degree

Offer:

  • work in a great team
  • interesting projects
  • professional development through coaching, self-study, in-house and external training
  • attractive salary package, adapted to suit your needs
  • work / life balance

As project engineer specialized in medical devices you help our customer(s) with quality risk management. You facilitate risk assessments with a multidisciplinary team. You ensure that assessments are well documented and applicable procedures are followed.
You are interested in and have strong affinity with quality assurance, quality risk management and applicable regulations, guidances and standards in the pharmaceutical industry. We are looking for someone with at least two years of experience in a GMP environment or with medical devices.

Needs:

  • minimum 2 years of experience in pharma or with medical devices
  • good writing skills in english
  • strong affinity with quality assurance, QRM, regulations
  • experience with risk management tools, preferably FMEA
  • can think strategically, likes to take initiative to optimize methods and processes
  • strong analytical skills, well organized, studious and precise
  • experience with filling, inspection, packaging, assembly equipment is a plus
  • master or bachelor degree

Offer:

  • work in a great team
  • interesting projects
  • professional development through coaching, self-study, in-house and external training
  • attractive salary package, adapted to suit your needs
  • work / life balance

As CSV consultant you execute computer validation projects on location at the customer or from our offices. You are involved with the analysis of user requirements, testing and implementation of new software solutions. Our customers count on your expertise related to regulatory requirements and your insights to manage project risks.

Needs:

  • minimum 2 years of experience in validation
  • good writing skills in english
  • strong affinity with computerized systems
  • strong analytical skills, well organized, studious and precise
  • master or bachelor degree

Offer:

  • work in a great team
  • interesting projects
  • professional development through coaching, self-study, in-house and external training
  • attractive salary package, adapted to suit your needs
  • work / life balance

As Project Engineer, you are responsible for determining the technical and user requirements, the selection, tendering and/or design of pharmaceutical equipment, facilities, utilities or automation. You ensure the follow-up during the different phases (design, construction, commissioning, etc.), as well as the proper and timely delivery of the project. You manage the change control process, the definition and execution of the validation strategy, Commissioning & Qualification.
You manage and keep the oversight of involved contractor companies, and ensure that their work is done on time, with the required quality and safety on site. You ensure the handover and support at start of operations.

Needs:

  • minimum 2 years experience in engineering for one or more of the following areas: HVAC, cleanrooms, utilities, pharmaceutical production equipment, packaging equipment, logistic equipment, automation
  • good spoken and writing skills in english, dutch and/or french are a plus
  • strong analytical skills, well organized, studious and precise
  • experience in the pharmaceutical industry and knowledge of cGMP is a plus
  • master or bachelor degree

Offer:

  • work in a great team
  • interesting projects
  • professional development through coaching, self-study, in-house and external training
  • attractive salary package, adapted to suit your needs
  • work / life balance

As a QC Analytical Method Validation Consultant you support and execute routine and project related analytical method validation activities. You perform Root Cause Analysis and support the implementation of preventive and corrective actions. You support the development, improvement and/or transfer of QC methods and assist in the writting of reports. You support the organization during internal and external audits.

Needs:

  • minimum 2 years of experience in QC laboratory or validation function
  • technical expertise in one or more of the following areas: ELISA, MDS, HPLC, nephelometry, cleaning validation, sample management
  • proven experience in Method Transfer
  • good technical writing skills in english
  • strong analytical skills, well organized, studious and precise
  • good knowledge of cGMP, knowledge of GCP is a plus
  • master or bachelor degree

Offer:

  • work in a great team
  • interesting projects
  • professional development through coaching, self-study, in-house and external training
  • attractive salary package, adapted to suit your needs
  • work / life balance