…  is a woman owned small business, dedicated to serve clients in the GMP chem/bio related vaccine / personalized medicine / GMO industry. We support with management system implementation, reviews of facility design and risk management approaches, evaluations, preparation for inspections and development of emergency- and crisis management- and communication plans..


You could say that Vips did not found the company, the company kind of found her. As her professional career developed, she was often approached by colleagues in her field, asking for assistance and help. One day  somebody said: “Ahh! ….. so what you really do is that “you just vipsit” and fix what others struggle with?” – and then she became a verb….

Today she is “Vipsit LLC ApS” – stepping in where others step out. She aims for timely due diligence and lays the ground-work for a successful project execution and completion in the complex field where guidelines clash and there is only field experience to rely upon.


Keep products, people, animals, environment – and project managers safe



Inspire and facilitate timely due diligence, excellence and success

when it comes to wrangling the twilight zone where guidelines clashes and there is no simple answer to even the most simple question, apart from – “it depends”



Vipsit works with private large scale facility owners, architects and engineering (A&E) design companies, lab-planners, project managers and safety professionals, equipment suppliers, maintenance engineers, scientists, technicians and support staff where additional risk management strengths, skill-sets and resources are needed.

We work predominantly with big private industry, and associated QA/QC laboratories, hospitals with GMP clean room requirements and production units targeting personalized medicine (stem cells etc.), animal facilities and GMOs etc., and sometimes we teach in schools and at universities. We work in the areas where things suddenly can get out of control when big utility systems fail, infectious agents and toxic chemicals can harm, where large scale spills occur, and exposure can happen. Facilities that gets designed today will be operational for many years into the future. The design must address the fact that guidelines and regulations in the future will become more stringent not less.

Almost all of the vaccine facilities we have engaged with over the years, including those Vips herself was responsible for back in her early career, has a streak of invincibility, as the staff is typically vaccinated. This means that even if accidents and exposure happens, a disease will be unlikely to evolve. However, just because you will not develop the disease yourself, does not necessarily prevent you from becoming a silent carrier and potential spreader of the disease, excreting and spreading agents into the environment or into the private households.

Vipsit work with early career professionals where we coach and mentor and help the coming generations to get traction in the field.

We support those that are aiming for BRM certifications and peer recognition.

We assist more seasoned career professionals with shortcuts to templates and tools we have developed for our own past projects throughout the years.

We sit in technical advisory boards and expert groups as senior SMEs and try to shape the world, and steer upcoming research, development and design projects free of some of the most common pitfalls. We share our past experience and support a project that needs extra resources, an outside set of eyes or a challenging mind for a limited time.

We come to assistance if your project derails, listen to your frustrations and help brainstorm on how to get it back on track before it ends up in court.

We have been there, been them all, we remember how it was, the long sleepless nights and we believe we can bring value to your current challenges and situation by sharing our past experiences and lessons learned.


Vipsit is a company that, throughout the last 30 years, has been involved in a broad variety of high containment construction projects especially where guidelines clash and design drivers pull in different directions. For many years we did not even have a formal web-site, but people in need would find us anyway through mouth-to-mouth success stories.


Vips, sometimes supported by her hand-selected team of subject matter experts (SMEs), aim for timely due diligence, lay the groundwork for successful project execution and deliver high value services for those we support. In some projects we coach and mentor, and sometimes our work focuses on reviewing individual projects and design suggestions where the deliverable will be a review report or questions in the margin with track changes. If you decide to involve us in your project, Vips will serve you herself, or if it is a bigger task, suggest a team of SMEs that together can serve your need.

We meet your needs depending on where you are in the process

  • Initial thoughts, considering how to initiate a project? (fact-finding and user interviews, process and design requirements, new construction, refurbishment, infill, brownfield, greenfield, templates, and checklists).
  • How to close out a project? (commissioning, validation, operational readiness, set up of maintenance systems, and training of staff).
  • Or how to rescue a derailed project and avoid meeting your contractors or suppliers in court. It all has to do with timely due diligence, and project management systems.

We have a strategic approach when we engage. Together with you we identify the critical path and the potential road blocks, we will assist you with developing tiered plans around those roadblocks, and always have a plan B in mind.

We listen before we talk. We recognize that all projects and challenges are unique, there is no “one size fits all” approach and that cookie cutters are for baking, not for facilities that must be compliant in a field where guidelines contradict each other.


Vips Halkjaer-Knudsen has more than 30 years experience in the chemical and biological field, and she has been in the consulting business since 2006. Today she willingly shares her past experiences from a range of large scale GMP and high containment construction projects.

She is a subject matter expert and has worked as a lead, as a team member in groups, as well as on her own, flying solo. She will assume the role you need. She has a highly qualified team of SMEs she reaches out to when needed.

20 Years as a Manager and DirectorVips has, throughout her career, overseen personnel from high performance academic R&D teams, technical staff in GMP QA/QC laboratories, large scale GMP production employees to blue collar service and logistic teams.

Successful leadership takes different strategies and tactics depending on the needs of the groups

International experience: …as a technical BRM subject matter expert.  After half a life holding the reins as director and vaccine facility owner, she decided to change career path, relocated to the other end of the world, joined a team of technical subject matter experts, and started working with international partners, organizations, companies, scientists and technicians within the worldwide biorisk management field.

Different business strategies and tactics work in different regions of the world

Project Management: Vips has worked extensively in the project management field. Real life experience from a vast number of large scale vaccine building projects has given Vips solid hands on expertise. Over time she has developed and fine-tuned a comprehensive toolbox of project management tools that are applicable in a number of industrial settings. 

There is a difference in what is taught in the project management courses and what happens in real life scenarios

GMP Documentation & SOPs: Vips is relying on her many years of GMP experience and has prepared for and passed several FDA GMP inspections. In all of her years at SSI, there was not a week that did not include the generation of relevant documents for GMP inspections, risk assessments, SOPs and in-house documentation.  

If you once have learned how to efficiently produce “Great Mountains of Paper”, it is impossible to unlearn it

Facility Design: She has lead design, commissioning, and validation teams, overseen pre-design & programming, detailed design, bidding, construction and commissioning phases on multiple projects on 6 continents. She is a scientist – not architect or engineer. 

She knows what is needed, and knows how to get experts in other fields and trades to do their magic, calculate dimensions, flows and utility system capacities, and make the visions, dreams, requirements, and desires manifest

Operation & Maintenance: The job is not done when the new facility is handed over to the client, actually the fun has just started. Vips has, during her early years in Denmark, had her hands deep down in the operational readiness and start-up of large scale facilities, development of commissioning testing plans, validation protocols, and outline of preventive/predictive operation and maintenance programs.

Impact Assessments (IA), identifying Performance Indicators (PI) and defining the best strategy for Operational Readiness (OR) will be important pieces to the jigsaw puzzle of getting the building operational the day it is handed over

Hands on Experience: Vips has crawled inside HVAC ducts, commissioned equipment and utility systems, spent countless nights in attics and basements, monitoring fermenters, production equipment and Building Management System (BMS) inconsistencies and filter failures, cleaned up and decontaminated after thousand-liter large-scale spills when suddenly a kill system in a vaccine production broke down or a fermenter or a single-use system suddenly ceased to be the closed system it was supposed to be.

Not all can be studied, …………………..… some things has to be experienced to fully understand it

Guideline Implementation: ISO 14001, 45001, 35001, 17025, 22000; CWA 15793 / 16335 / 16593 and GAP IV. If you have never heard about these, don’t worry, just be happy!

After the first couple of implementations it becomes clear that this is about applying a robust methodology to the task, not the individual guideline and its content itself

URS’ and more: You cannot be involved in  animal vaccine research, testing and large scale GMP vaccine facility constructions and refurbishment projects and not become skilled in tenders, procurement specifications, performance and user requirement specifications. DQ, IQ, OQ and PQ, FAT and SAT protocols and reports are all GMP documents that are imperative for the success of these production facilities. Evaluation and selection of qualified A&E companies, consultants and contractors with a successful track record in this field is also of extreme importance.

If the strategy and structure of the information listed in the documents are well thought through, many work-hours can be saved downstream in the project. Same database can generate test documents and protocols if it is planned from the beginning

Polio & GAP IV: Vips has now for more than 10 years been serving as a SME for the World Health Organization (WHO) in the Containment Advisory Group (CAG) for Polio eradication. The CAG addresses questions and challenges regarding the worldwide Polio containment implementation. 

After a while it becomes clear that this is less about Polio, and more about a methodology addressing emerging and eradicated diseases

Coach and Mentor: After having been “advising and mentoring” younger colleagues for half a life time, Vips found it prudent to actually get a formal coaching certification.

She mentors and shares her past experiences when that is prident and mentors the rest of the time. The difference? Well it is like being in a gym, are you lifting the weights for those who reach out to you? Or are you allowing them attending the gym and over time to get stronger by asking the right questions while hey build their muscles themselves?

Today Vips blends the two methods together. No reason to ask people to go roaming for guidelines and regulations if they already exist in her vault, she will share of course.

But “paying forward” and building the next generations are to build muscle memory within the processionals that are reaching out. It takes time to read, think, process, digest and conclude. The biggest challenge is, when people come with the expectations of “asking the Oracle in Delphi” and then accept sometimes the answer will be ….”it depends…. tell me more, and walk me through what you are thinking, and then I will point you in the direction you need to go, or share the links to the litterature you need to read”.

Trainer, Instructor & Author: Vips has more than 30 years experience as a speaker/trainer/instructor and workshop facilitator. She has given more than 150 professional talks at conferences all over the world, taught even more half and full day courses in the “hard” as well as the “soft” topics that are mentioned on this web site.

In her spare time she reviews and edits guidelines, publishes papers and book chapters … because it is fun and she truly enjoys it. She is supported by one of the most skilled and recognized educators on the continent, and relies heavily on support when it comes to highly advanced technical systems curriculum design and statistical analyses and methodologies.