Pharma & biotech - Ramboll Denmark's organisation and competences

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RAMBØLL DENMARK PHARMA AND BIOTECH CONSULTANCY

description

Ramboll has more than 30 years of experience with the pharmaceutical and biotech industry. We have established an international network and we can provide strong specialist competencies in all disciplines with a special focus on GMP (Good Manufacturing Practice).

Transcript of Pharma & biotech - Ramboll Denmark's organisation and competences

Page 1: Pharma & biotech - Ramboll Denmark's organisation and competences

RAMBØLL DENMARK

PhARMA AND BiotEch coNsuLtANcy

Page 2: Pharma & biotech - Ramboll Denmark's organisation and competences

organisation

Pharma(BriJ)

Construction(mDtJ)

Laboratories(BJm)

Production(BriJ)

EL & Bms(mrmJ)

DEPartmEnt anD tEam managErs

DEPt. Pharma & tEam ProDuCtionDept. manager Brigitte JarbergMobil +455616491, mail [email protected]

Contract and executive responsible for all projects roote in any of the four teams within pharma.team ProductionTeam deliver projects within Critical Utilities (WFI, PW, Comp. Air, gasses, etc.), Clean Room HVAC, Process installations, GMP, Qualification, Valida-tion, project management.

tEam ConstruCtionteam manager morten Darø tranholmMobil: +4551616128, mail: [email protected]

Team deliver projects within building and structural engineering, addition-al load on existing structures, evaluation of concrete structures, erection supervision, execution and analysis of various NDT methods, FEM analysis and project management.

tEam LaBoratoriEsteam manager Bjarke møller nielsenMobil: +4551614691, mail: [email protected]

Team deliver projects within laboratories, animal facilities, clean room facilities, insulation sections, operation room, HVAC, utilities and project management.

tEam EL & Bmsteam manager martin raymond Jensen Mobil: +4551619966, mail: [email protected]

Team deliver projects within both high and low voltage electrical installa-tions, power bsck-up solutions and UPS, automation solutions (CTS, BMS, FMS, SCADA, ect.), risk evaluation, CE-marking, GAMP, validation and project management.

Project Director(CoK)

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Frank Berner holmEngineer +45 51 61 62 10, mail: [email protected]

Mr Frank Berner Holm has a solid background in project management and design of electrical systems, primarily supply and control systems, and automation installations for building automation and process installations within construction and pharma-ceutical industry. Frank’s skills portfolio includes special competence in the field of automation and process installations, including:

• Multidisciplinary sparring• Emergency supply• Electrical switchboards• Documentation• Laboratory installations, including GMO• Machine installations• CE marking according to the Machinery Directive• Pharmaceutical installations according to GMP• ATEX installations

hanne holmgreenProject Manager +45 51 61 65 06, mail: [email protected]

Ms Hanne Holmgreen is a specialist with extensive experience in the design of venti-lation systems and piping for laboratory construction, specialty laboratories, animal stables and clean rooms.Furthermore, Hanne has extensive experience of project and design management with small and medium construction cases. For the last 28 years, Hanne has specialized in the validation of pharmaceutical industry. Hanne also has experience in the design and supervision of administration and industry.

steen Borup JensenSenior Project Manager +45 51 61 86 40, mail: [email protected]

Steen Borup Jensen has accomplished a wide range of professional competencies within business development, leadership and project management. For the past 12 years Mr. Jensen has worked as a consultant for the pharmaceutical industry and has a solid background in project management, QA services, clean utilities, tender and tender evaluation, contract negotiation, planning and supervision of time, quality and economy. Steen Borup Jensen has a wide experience as a project engineer on both large and smaller pharmaceutical projects. His experience is gained primarily from design of clean utility installations and QA services including User Requirement Specifications, DQ, IQ and OQ services.

Christina seyfarthEngineer +45 51 61 85 26, mail: [email protected]

Mrs. Christina Seyfarth is a specialist with in HVAC design and engineering and she is also a very skilled project manager. She has for many years been working with HVAC for laboratories, hospitals and pharma. production facilities.Further Mrs. Christina Seyfarth is a Clean Room specialist and have done both de-sign, construction, testing, qulification and validation of clean room facilities. She has a high knowledge on GMP and GLP.

ComPEtEnCEs

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henrik goldschmidtProject Manager +45 51 61 45 02, mail: [email protected]

Henrik Goldschmidt (Chemical Process Engineer) has for the past 17 years worked with all phases of projects in farmaceutical industry, laboratories or hospitals.Most projects has been regarding GMP critical supply systems like Purified Water, WFI, Pure Steam, Medical gasses (comp. air, nitrogen, oxygen, e.c.t.) and waste water (e.g. inactivation and neutralisation). Plus some projects within process equipment like filtration, drying, filling, packing lines, incubators, cold storage room and whole pilot plants.Henrik has a wide experience as a project engineer on both large and smaller phar-maceutical projects. His is highly experienced within GMP, Design, including User Requirement Specifications, DQ, IQ, OQ, PQ and Cleaning Validation services.

Christian Østerby KnudsenProject Manager +45 51 61 64 65, mail: [email protected]

Christian Knudsen`s personal competencies have three absolute strengths:Christian always meet the task with a positively openness and good humor, “Everything is possible until proven otherwise”. Tasks are carried out responsibly and with ownership. Christian is used to navigate at all levels in the organization and have experience in reporting to Director Level. Cooperation with all the construction industry with respect for everyone`s roles and disciplines are also an important part of Christian`s skils. Christian`s ability to listen and understand their needs and organized project team benefits then characterize the daily working. Christian is a graduate civil engi-neer in construction and has worked primarily with concrete structures, concrete an steel structures. in addition, the many project tasks give a broad knowledge of other engineering disciplines.

Carsten rasmussenSenior Chief Consultant +45 51 61 45 84, mail: [email protected]

Carsten Rasmussen has more than 25 years of experience of working within phar-maceutical industry. He has deep knowledge and experience in facility design. He possesses in depth knowledge of contamination control and unit operations and equipment used in pharmaceutical industry. He has besides formal training, through many projects developed skills and experience as a project management in com-plex projects within Pharmaceutical Industry, Healthcare and Universities. Operation theaters.

Key words: Facility Design, cGMP, Clean Room Technology, Aseptic production, Chemical and Biological safety and containment, GMO, BSL, HVAC, LAF/UDF tech-nology, Isolators, Safety cabinets, lyophilisation, freeze dryers, autoclaces, sterilisa-tion and project management.

ComPEtEnCEs

morten hergott nielsenElectrical engineer +45 51616427, mail [email protected]

Mr Morten Hergott Nielsen has a solid background in design and dimensioning of power distribution plants for residential and commercial building, rest homes, schools and the pharmaceutical industry, including authority negotiations. His ref-erence list includes new construction, reconstruction and restoration of rest homes, including commercial kitchen, patient paging systems, dementia protection and lighting. Morten has worked many years with design of road lighting systems, in par-ticular as regards roundabouts.