Validation and Commissioning Specialist

1 week ago


Copenhagen, Copenhagen, Denmark AM Group Full time
CQV (Commissioning, Qualification & Validation) Engineer

At AM Group, we challenge the norm in consulting by utilizing well-established management and engineering tools to deliver tangible improvements to our clients' businesses.

We bring experience to know when to act and do it with your people so they can learn and take over when our job is done. Our approach applies simple, reliable management tools to improve our clients' business.

Job Summary:

We are seeking a skilled Commissioning and Qualification Engineer to play a crucial role in the successful execution of commissioning and qualification activities for pharmaceutical/biotech manufacturing facilities.

The ideal candidate will generate test packages, coordinate and execute commissioning and qualification processes, and provide operational expertise.

Key Responsibilities:

  1. Develop commissioning and qualification test packages or support others in generating respective documents. Coordinate and execute commissioning and qualifications (FAT/SAT/DQ/IQ/OQ/PQ).
  2. Perform commissioning and qualification within a plant environment, including interacting with plant equipment and Upstream and Downstream Processes (USP/DSP).
  3. Create test plans for qualification, supporting QA teams.
  4. Regularly report the status of assigned work.
  5. Bring operational experience during the commissioning and qualification phase.
  6. Support automation engineers with operational knowledge.

Requirements:

  1. Minimum 2 to 8 years of experience in commissioning and qualification of equipment in new pharmaceutical/biotech manufacturing facilities.
  2. Hands-on process engineering and/or operational experience.
  3. Prior knowledge of working on plants operated with an MES is desirable.
  4. Experience in plant planning and project management with a focus on plant automation or projects in technical computer science.


  • Copenhagen, Copenhagen, Denmark Optimus Life Sciences Full time

    Validation and Commissioning Expert WantedOptimus Life Sciences seeks a highly skilled Validation and Commissioning Expert to join our team in Copenhagen, Denmark. As a key member of our engineering team, you will be responsible for ensuring GMP compliance for the engineering department.About the Role:This role involves developing and implementing effective...


  • Copenhagen, Copenhagen, Denmark QCS Staffing Full time

    About the RoleThe Engineering and Commissioning Specialist will play a key part in our client's CAPEX investment programme. With a focus on process development and cGMP production, this role offers a unique opportunity to make a genuine contribution to the biopharmaceutical industry.Main ResponsibilitiesDevelop and implement change management records for new...


  • Copenhagen, Copenhagen, Denmark Optimus Life Sciences Full time

    Job Title: Pharmaceutical Engineer – Commissioning SpecialistWe are seeking an experienced CQV Turnover Engineer to join our team at Optimus Life Sciences in Copenhagen, Denmark. This is a 12+ month contract opportunity.About the Role:This role involves carrying out hands-on CQV activities post documentation phase, executing commissioning of various...


  • Copenhagen, Copenhagen, Denmark AM Group Full time

    CQV (Commissioning, Qualification & Validation) EngineerAM Group - partner of Consultys - is a consulting company based on experience and a desire to challenge the norm.We believe in approaching consulting differently. Instead of relying on complex theories that only work in ideal scenarios, we utilize well-established management and engineering tools to...


  • Copenhagen, Copenhagen, Denmark AM Group Full time

    CQV (Commissioning, Qualification & Validation) Engineer AM Group - partner of Consultys - is a consulting company based on experience and a desire to challenge the norm. We believe in approaching consulting differently. Instead of relying on complex theories that only work in ideal scenarios, we utilize well-established management and engineering tools to...


  • Copenhagen, Copenhagen, Denmark AM Group Full time

    CQV (Commissioning, Qualification & Validation) EngineerAt AM Group, we strive to challenge the norm in consulting. Our approach involves utilizing established management and engineering tools to deliver tangible improvements to our clients' businesses.We bring the experience to know when to do what and apply it with your people so they can learn and take...


  • Copenhagen, Copenhagen, Denmark QCS Staffing Full time

    Job DescriptionThe Responsible Engineer will lead change management records for new equipment, support project scoping, installation, commissioning, qualification, and validation activities, as well as provide input on risk assessments. Key responsibilities include:Lead change management records for new equipment and through release of equipment to...


  • Copenhagen, Copenhagen, Denmark QCS Staffing Full time

    About the RoleQCS Staffing is seeking a skilled Mechanical Commissioning Specialist to lead the commissioning of mechanical infrastructure systems in a large hyperscale Data Centre project based in Copenhagen.ResponsibilitiesOversee all aspects of safety for mechanical tests, ensuring compliance with relevant regulations and standards.Develop and implement...


  • Copenhagen, Copenhagen, Denmark Optimus Life Sciences Full time

    About the JobWe are looking for a Process Commissioning Specialist to join our team at Optimus Life Sciences. In this role, you will be responsible for leading and performing CIP commissioning for critical systems, ensuring they meet all required operational and safety standards.Responsibilities:Commissioning of process equipment including tanks, buffer...


  • Copenhagen, Copenhagen, Denmark Hamlyn Williams Full time

    Hamlyn Williams is seeking an experienced E&I Engineer to join our team in Denmark.E&I Specialist Consultant | Validation EngineeringThe successful candidate will have a strong background in automation and validation engineering, with experience working on large-scale pharmaceutical projects.Key Responsibilities:Liaising with vendors to ensure smooth project...

  • Technical Lead

    2 hours ago


    Copenhagen, Copenhagen, Denmark PM Group Full time

    Technical Lead RoleWe are seeking a highly skilled Technical Lead to oversee the commissioning, qualification, and validation of process equipment on our large scale Pharma Project based in Denmark.As a seasoned engineer, you will have extensive experience working on process equipment and a strong understanding of the latest industry practices.In this role,...


  • Copenhagen, Copenhagen, Denmark Pharmatec Srl Full time

    We are seeking a Utilities Commissioning Lead to oversee the development and implementation of clean and black utilities systems at Pharmatec Srl.Utilities Commissioning LeadThis role involves leading commissioning, qualification, and validation activities, developing and reviewing CQV documentation, and collaborating with cross-functional teams to ensure...


  • Copenhagen, Copenhagen, Denmark Copenhagen Airports AS Full time

    Som Commissioning Manager hos Københavns Lufthavne A/S (CPH) har du en central rolle i et af de mest ambitiøse byggeprojekter i lufthavnens 100-årige historie: Terminal 3-udvidelsen. Du vil være med til at sikre, at 60.000 nye- og 11.000 ombyggede kvadratmeter fungerer optimalt og overdrages sikkert til driften. Du træder ind i et dynamisk miljø, hvor...

  • Commissioning Manager

    2 weeks ago


    Copenhagen, Copenhagen, Denmark Copenhagen Airports AS Full time

    Som Commissioning Manager hos Københavns Lufthavne A/S (CPH) har du en central rolle i et af de mest ambitiøse byggeprojekter i lufthavnens 100-årige historie: Terminal 3-udvidelsen. Du vil være med til at sikre, at 60.000 nye- og 11.000 ombyggede kvadratmeter fungerer optimalt og overdrages sikkert til driften.Du træder ind i et dynamisk miljø, hvor...


  • Copenhagen, Copenhagen, Denmark AM Group Full time

    CQV (Commissioning, Qualification & Validation) EngineerAM Group seeks a skilled Commissioning and Qualification Engineer to join our team. As a member of our team, you will play a crucial role in the successful execution of commissioning and qualification activities for pharmaceutical/biotech manufacturing facilities.What You Will Do:Generate commissioning...


  • Copenhagen, Copenhagen, Denmark Curia Management ApS Full time

    Senior Commissioning Specialist - med stærke projektlederkompetencer Vil du være en del af en ung, højt specialiseret koncern i kraftig vækst? Interesserer du dig for granskning af driftsproblemer, commissioning, performancetest og idriftsættelse af komplekse tekniske installationer? Og har du lyst til at være med til at skabe yderligere vækst gennem...


  • Copenhagen, Copenhagen, Denmark AM Group Full time

    CQV (Commissioning, Qualification & Validation) EngineerAs a Commissioning and Qualification Engineer at AM Group, you will be part of a team that delivers tangible improvements to our clients' businesses using established management and engineering tools.We believe in applying simple, reliable management tools to improve our clients' business. Our team...


  • Copenhagen, Copenhagen, Denmark AM Group Full time

    CQV (Commissioning, Qualification & Validation) EngineerWe are looking for a skilled Commissioning and Qualification Engineer to join our team at AM Group.This role involves generating test packages, coordinating and executing commissioning and qualification processes, and providing operational expertise.Job Requirements:Minimum 2 to 8 years of experience in...


  • Copenhagen, Copenhagen, Denmark Curia Full time

    Senior Commissioning Specialist - med stærke projektlederkompetencerVil du være en del af en ung, højt specialiseret koncern i kraftig vækst? Interesserer du dig for granskning af driftsproblemer, commissioning, performancetest og idriftsættelse af komplekse tekniske installationer? Og har du lyst til at være med til at skabe yderligere vækst gennem...


  • Copenhagen, Copenhagen, Denmark AGC Biologics Full time

    At AGC Biologics, we are committed to continuous innovation and fostering technical creativity to solve our clients' most complex challenges. We are seeking a talented Method Validation Specialist to join our team in QC Chemistry.This role involves driving PhI/II and PhIII/Commercial method validation activities, reviewing release and stability analytical...