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Commissioning and Qualification Lead Boxmeer SIRE Life Sciences

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Gevraagd

  • 37 - 40 uur
  • Senior

Aanbod

  • Vast contract
 

Vacature in het kort

Boxmeer
Join a global leader in animal healthcare, where your expertise in commissioning and qualification will drive innovation in pharmaceutical engineering projects. As a Commissioning & Qualification Lead, you will ensure equipment and processes meet compliance standards while leading a multidisciplinary team. Enjoy the satisfaction of contributing to public health and food safety, and benefit from opportunities to implement process improvements and deliver impactful training sessions. Read on to see what career growth opportunities this role offers.
 

Over het bedrijf

SIRE Life Sciences
Werving en selectie21 - 50 medewerkers
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The Company 
Our client is a global animal healthcare innovator, information technologies, and veterinary services supplier. This company’s science supports the precious bond between people and their pets. They are helping to ensure and protect international public health, food safety and the increasing of protein supply.   

Role Description
As a Commissioning & Qualification Lead, you will support validation and qualification activities for pharmaceutical engineering projects, ensuring equipment, systems, and processes are delivered in a compliant and validated state. The role involves both hands-on execution and strategic oversight of CQ activities, particularly within the areas of cleaning and sterilization validation. You will work within a multidisciplinary team, collaborating closely with departments such as QA, QC, Global Engineering, and IT to uphold GxP standards and drive process improvements. This position reports to the Resources Site Engineering Manager and involves coaching and guiding CQ engineers to ensure smooth project execution. 

Responsibilities

  • Coordinating and executing validation activities including equipment performance qualifications, especially cleaning and sterilization validations.
  • Writing and maintaining validation documentation: validation master plans, SOPs, protocols, and final reports.
  • Analyzing validation data and troubleshooting technical issues during execution.
  • Planning and allocating CQ tasks across projects in consultation with Project Managers and the Resource Manager.
  • Coaching and supporting CQ engineers to ensure activities follow standardized procedures and comply with GxP and non-GxP requirements.
  • Leading CQ efforts in large-scale projects, overseeing cross-functional teams and managing stakeholder alignment.
  • Developing and implementing process improvements within the CQ domain.
  • Ensuring compliance with evolving regulatory standards and update procedures accordingly.
  • Delivering CQ-related training within Site Engineering.
  • Representing CQ interests in department meetings and escalating issues when needed.
  • On occasion, carry out space, utility, and equipment qualification activities directly, including writing protocols, reviewing specifications, and coordinating with stakeholders. 

Requirements

  • Bachelor's or Master’s degree in (bio)chemistry, food technology, life sciences, or a comparable technical field.
  • 3–5 years of leadership or coaching experience in a pharmaceutical CQ-related role.
  • Experience as a senior QA officer or within quality assurance in the pharmaceutical or food industry is an asset.
  • Strong coaching, planning, and leadership abilities.
  • Decisive and capable of implementing improvements.
  • Excellent communication skills in Dutch and English.
  • Detail-oriented, structured, and able to work independently.
  • Team player with a hands-on mindset.
  • Knowledge of pharmaceutical commissioning and qualification processes is essential; internal training is available.
  • Familiarity with Computer System Validation is a plus. 

Other information  
Apply to our vacancy for more information. Looking forward to getting in touch!   

55117

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