Consultant Services

We´re different in ways

That will matter to you

What’s the difference between a highly trained subject matter expert and a practical, hands-on person who can implement cross-functional know-how to move your business forward? At KeyPlants, there’s no difference at all. 

We match junior and senior consultants to your needs and match their personalities to your corporate culture and project team. We back up our consultants with the expertise of the whole organization. Experienced colleagues on both the project and consulting sides of our business are always ready to assist the consultant who is working with you. That can mean contributing specific expertise or nuts-and-bolts, problem-solving insight into the challenges of the assignment under way. All based on KeyPlants’ own extensive project experience from around the world. 

Experts on call

Every organization is different, with its own complexities and unique parameters. We offer a range of expertise both for large assignments or when you need an extra resource within your organization or project team. Some of our more experienced consultants can also function as team leaders within your organization.

Our specialist consultants work across the life sciences industry, including:

  • Pharma
  • Bio-tech
  • Medtech

Specific expertise includes Project management, QA, validation leadership, validation engineers, process engineers, and project leadership.

 

Consulting Services

The KeyPlants difference 

Our consultants’ heritage comes from the project side of the life sciences industry. That makes our consultants not just different, but different in practical ways that will matter to you. To start with, our consultants are not just specialists in their own fields, they have experience working in cross-functional teams on our own projects. This means that our consultants are not “silo” thinkers but are used to constantly seeing how all the parts of a project fit together – and working cross-functionally to get things done. You will find that they not only “know their stuff,” they will instinctively see how their own work fits into the big picture: Your business. 

Our consultants also have a mindset of taking ownership and responsibility for their piece of the puzzle. That means they have an ingrained understanding of what follow-through really means, all the way to the completion of a given assignment. 

On the project side of the KeyPlants business, quality, safety, precision, agility, and sustainability are our guiding stars. Our consultants bring those very same values to working with you because part of their training includes being assigned to KeyPlants’ own projects before they are assigned to you. 

Importantly, because our consultants have been trained on KeyPlants’ own projects, some of them have experience not just working in a team but leading a team. This gives you the option of choosing a consultant to lead a team within your own organization. 

 

Worldwide experience, cross-cultural mindset 

We work with some of the largest and most prestigious corporations in the life sciences industry. We work with small, entrepreneurial companies and start-ups. We work on large, multi-million-dollar projects and much smaller projects or parts of larger projects. We work in Sweden. And we work around the world. 

Our international experience means that as we grew, a distinct multicultural mindset evolved. Today, our consultant are comfortable working anywhere in the world and comfortable working on teams with people from all over the world. We believe there is no substitute for getting out of our comfort zones, challenging our own assumptions and experiencing how people in other cultures think and act. Our international experience also means that we are accustomed to working with regulators, authorities, and standards agencies setting different rules. 

All of this means this: We’ll never make you choose between a consultant who is a highly trained subject matter expert and one who is a practical, hands-on person who can implement cross-functional know-how to move your business forward. Because our consultants are both. 

Commissioning, qualification and validation (CQV)

    Our CQV consultants are experienced in both leading and performing commissioning testing, qualification and validation of equipment, cleanroom, automation, and IT systems in the life sciences industry.  

    Their training and background in turnkey delivery of facilities for the industry gives them a practical, solution-oriented outlook and an ability to see projects through from beginning to end.  

    From construction quality assurance to automation systems, we’ll show you how to meet the most stringent quality, cost, and schedule requirements. Our Project Delivery services include: 

    • Development of commissioning and qualification plans 
    • Design review and qualification 
    • FAT/ SAT planning and execution support 
    • Commissioning protocol development, site execution, and reporting 
    • IQ/OQ protocol development, execution, and reporting 
    • Process validation and cleaning validation support 
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    Quality assurance 

    Our Quality Assurance consultants can help you with your daily QA work according to your existing quality system or help you develop or expand your quality system. 

    Our Quality Assurance consultants are backed up by an organization that has worldwide experience with regulations in different countries. And they are experienced enough to see the full picture as well as take the “tough decisions.” Their training and background in turnkey delivery of facilities for the industry also gives them a practical, solution-oriented outlook and an ability to see projects through from beginning to end.  

    With us, you become part of a creative and welcoming company where everyone has the opportunity to develop their skills. We also hope that you will learn as much from us as we will learn from you. In addition to an attractive work environment, we offer a wide range of benefits. For many of our job openings, you will need a bachelor’s or master’s degree or similar in engineering.

    Automation

    KeyPlants automation delivers a full spectrum of automation services to customers, ranging from complete project delivery to on-site consulting services. Based on our own quality systems and project development methodology, we can offer complete application development, testing, quality assurance and documentation for your projects. This includes: 

    • System independent conceptual and basic automation designs 
    • Full Distributed Control Systems design and implementation 
    • Full PLC/SCADA solution design and implementation 
    • System upgrade/replacement 
    • Both Batch and continuous system design 
    • Cabinet I/O Layout and design 
    • Site based consulting and troubleshooting support 
    • In-house development and test systems 

    The team at KeyPlants automation has extensive experience across multiple industries with special focus on such GMP-regulated environments as pharmaceuticals and biotechnology. All of our consultants work according to established international standards and guidelines including ISA S88, ISA S95 and GAMP. Our automation team has extensive experience and skills with Emersons DeltaV DCS, ABB Sattline DCS, Siemens SIMATIC PCS7 DCS and Siemens TIA Portal. 

    Facility design

    A successful design manager needs to understand the key design criteria for how product quality and GMP can be built into a design. At KeyPlants, that understanding comes from broad knowledge in all building disciplines attained through many of our own projects and an extensive background from manufacturing modular and conventional facilities for the pharmaceuticals industry, 

    Our design managers will use their practical, real-world experience to lead the design of your project around all possible obstacles, avoiding unnecessary gold-plating, so you can meet schedule and budgets – and always with product quality as the top priority. 

    Process Design 

    Using modern design tools and the industry’s sharpest engineers, we will develop your process from description to a GMP-compliant process design for procurement, installation and validation. Our process engineers can support your team and organization with expertise in such areas as: 

    • OSD 
    • Aseptic formulation and filing 
    • Biopharmaceuticals 
    • Small molecule APIs 

    KeyPlants’ engineering experts are ready to assist you in ensuring your design and operation complies with all regulatory requirements. We are used to working in an international environment, complying with local building codes and guidelines and cooperating with local engineering firms all over the globe. We will perform efficient design reviews of your design in relation to GMP or other applicable regulations, based on extensive experience from around the world. 

    Project management and support 

    KeyPlants knows what it takes to manage a project and make it profitable. That has been our business from the start. Over many years, we have executed a large number of projects around the world and are used to working with both large and small clients, many of which are leading A/E’s and construction companies. 

    Today, we are sharing that expertise with clients via our experienced project managers, who ensure successful project deliveries through effective planning, backed by an experienced team. We offer senior PM for large projects, technical project leaders, as well as project planning or project admins. 

    We have the experience and tools in place for monitoring progress and maintaining robust control throughout the lifecycle of a project, ensuring any challenges are effectively addressed – to meet your time, cost, and quality objectives. Through an execution model proven via many project deliveries over the years, we help reduce our clients’ risk and deliver projects in a predictable manner, for any project phase in which we are involved.

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    Work as a consultant

    We’re recruiting for a new hybrid project/consulting business that will offer expertise to the #lifescience industry. Are you curious, adventurous, and ready for a fantastic journey? If so, we offer an international environment in which you would collaborate on interesting technical solutions that improve people’s lives.

    We’d love to hear from you!

    Contact us today – we will help you to master your specific challenge.

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