Our consultants

AL Engineering has a broad network of specialists and partners with whom we collaborate. In addition, we have agreements with freelancers with extensive experience within our core competence and the associated areas.

More than 20 years of experience with pharma and skills in:

Pharmaceutical & biotechnological processor
Medical equipment industry
Supply systems
Project Management
Quality activities
Authority inspections
GMP

10 years of experience within the pharmaceutical industry with special skills in:

Temperature mapping

Change requests

Deviations or Non conformities

Qualification of equipment and space

Drawing up SOPs and holding training

IT/SW validation (GAMP5)

Validation & qualification of cold rooms

More than 20 years of experience in Pharma with special skills in:

Validation & qualification of incubators, cold rooms & laboratory equipment
Qualification of environmental monitoring in clean rooms
GMP, GTP and GDP
VPL/VPR, IC, OC, IQ, QQ, PQ, CV & PV
Preparation of PSE & trend reports for clean room equipment & internal environment

17 years of experience with production, construction & validation within Pharma with special skills in:

CB, CD, BD & DD design phases
Capacity analyses, process design & specification requirements
URS, TS/UDS & RRA
Environmental monitoring, validation, risk assessment, protocols, review & reports
Qualification and validation of purification processes (HPLC, AIEC)

30+ years of experience within the pharmaceutical industry with special skills in:

Qualification of environmental monitoring in clean rooms
GMP, GTP and GDP
QA specialist
Validation of water systems and HVAC systems
Deviations or Non conformities
Cleaning validation
Qualification and validation of production equipment
Drawing up SOPs and holding training

Has 20 years of experience in the pharmaceutical industry and has competencies in:

Pharmaceutical & biotechnological processor
Supply systems
SME / Advisor / WPO
Project Management
Quality activities
Authority inspections
GMP

15+ years’ experience with pharma and more than 25 years’ experience with QA & audit. In addition, Keld has competences in the following areas:

Project Management
Validation/qualification
Processor/supply systems
Authority inspections
GMP

Mechanical engineer with great interest in and experience with process engineering in AutoCAD and special skills in:

GMP
Process design
Specification/dimensioning of process components (2D/3D)
Tests in connection with FAT, SAT and IV
Mechanical lead and coordinator
Trouble shooting of process equipment during shutdown

Industrial technician and machinist with good experience with Engineering in AutoCAD, AutoCad Plant 3D, Inventor and navisWorks with special skills in:

GMP
Process design
Specification/dimensioning of process components (2D/3D)
Tests in connection with FAT, SAT and IV
Preparation of tender material
Cleaning, flush and draining procedure

Mechanical engineer with great interest in and experience with process Engineering with special skills within:

GMP
Qualification and validation
Project management with a PRINCE 2 Foundation
Data analysis
Temperature mapping
QA/QC

20 years of experience with Pharma and has strong skills in:

API production & support
Design & requirements documentation
Qualification & validation of equipment & processes
Washing validation & monitoring
GMP inspections
Sattline, DetlaV, LIMS, E-tims, etc.

Personal assistant for handling daily administrative tasks
Psychotherapist for employees (and their immediate family) in AL Engineering A/S to, with care and support, ensure the employees’ personal and work well-being, including creating a balance between work and leisure.
Administrator for social media activities
Organizer of professional and festive events for employees of AL Engineering A/S
Ad hoc tasks as a consultant (assistant tasks)

Electrician and machinist with extensive experience in the establishment, quality control and maintenance of facilities and production equipment. In addition, experience as a process engineer.

Maintenance of production equipment
Quality control of equipment from subcontractors
Optimization of production equipment
Problem solving
Quality activities

Mechanical engineer with extensive experience in packaging and transport, particularly aimed at pharmaceutical products and cold chain transport.

Cold chain solutions
Transportation
Packaging materials
Risk assessments
Qualification/Validation
GxP
Development of operationally stable and durable design solutions
Analytical and theoretical understanding
Problem solving

Ann Louise Augsburg Sindet is a trained nurse, through which she has worked with quality assurance.

Qualification/Validation of In Process Control (IPC) equipment
Documentation
Project assistance
Knowledge of sterile processes

Process engineer with specialization in chemical technology, microbiology, production, process engineering, process and production development.

Qualification & Validation of Process Equipment and Processes
GMP inspections
Documentation
Risk assessment
Project assistance
Environmental monitoring
Annex 1
PQ Clean room

Experienced manager with a Master of Science in biology and chemistry. Allan has +20 years of experience, i.a. in the food, ingredients and pharmaceutical industries as a chemist, qualified person (QP), laboratory, quality and operations manager.

Management within QA and laboratories
Pharmaceutical production of API and finished products
Establishment, operation and dismantling of laboratories
Development and maintenance of quality systems
Quality assurance and optimization of processes
Qualification of laboratory and production equipment

Experienced consultant +15 years of experience within the pharmaceutical industry with special skills in:

GMP
Qualification & Validation within Pharma
Project Management
Preparation of NCs, Change Requests & SOPs
PQ/PV protocols/reports
Environmental monitoring
GxP, NC’s, CR’s
Performing FMEA risk assessments
Design of technical solutions according to customer requirements
Problem solving

More consultants

At AL Engineering, we have a broad network of specialists and partners with whom we collaborate. In addition, we have freelancers with extensive experience within our core competence and related areas.

The combination of a permanent team and freelancers ensures us an optimal balance between fixed and variable skills in an industry that is constantly developing.

At AL Engineering, we ensure a high specialist level, so that we can at all times live up to the responsibility our customers give us.

Our consultants

John Albertsen

Christina Kruse

Gitte Emde

Karina Nikolajsen

Ulla Karlshøj

Thomas Kjær Beknow

Keld Andersen

Jesper Junge

Christian Jensen

Mansoor Ali Sultan

Jesper Nikolajsen

Camilla Povlsen

Karsten Gyldmark

Steen Erik Larsen

Ann Louise Augsburg Sindet

Malene Stadager

Allan Povlsen

Kevin Firth

More consultants