Validation Engineer

Noord Holland - Nederland - Life Sciences & Health Care - Healthcare - Medisch - WO Master

Our Product Development department is currently looking for a Process Validation Specialist, being the subject matter expert for the organization.

Vragen? Neem contact op

Imre Heezen, Consultant

Solliciteer

Over deze functie

As our specialist, you will be responsible for defining the process validation approach for the organization. You will also coordinate its execution to support the CMC (Chemical, Manufacturing, Control) development of human plasma derived medicinal products. And you are responsible for the technology transfer of new processes to commercial organization and the regulatory submission of new products/new processes.
Your main task will include:• developing, documenting and implementing policies and procedures in line with applicable regulations;
• training employees and advising the organization on process validation approach;• structuring and implementing quality by design approach for CMC development activities;
• implementing a down scale model validation program for the development laboratory;• generating validation and qualification protocols and reports;
• defining, structuring and supporting validation activities within the Product Development department and• defining and coordinating the process validation activities for the technology transfer of new products/processes to commercial manufacturing organization.

Over jou

Your profile is:• at least MSc educational level in the field of process/chemical engineering, biotechnology engineering;
• 5+ years of proven experience in process validation in the (bio)pharmaceutical industry and implementation of quality by design guidelines;• knowledge of regulations applicable to investigational products, plasma derived product/process development, virus safety of biologics products and related ICH guidelines;
• knowledge of GLP (good laboratory practices), GCP (good clinical practices) and GMP (good manufacturing practices) regulations;• knowledge of protein purification techniques;
• knowledge of guidelines and techniques for validation, scaling-up and scaling-down production processes and of virus removal techniques;• knowledge of equipment qualification, cleaning validation and
• good command of English language (written and spoken), Dutch language is a plus.

Wat wij bieden

Brunel offers outstanding individuals a highly diverse and challenging job opportunity in a company where an open, professional and pleasant working culture is greatly valued; where your personal initiatives will be noticed and rewarded; and where you will receive all the support, coaching and training you need for your future career. This is your opportunity to discover a wide range of sectors and activities and develop your expertise in a fast-moving and results-oriented environment.

Being intermediated by Brunel means that you are contracted by Brunel. Not only you will have a contract, you will as well be assured of a great career! Our primary and secondary terms of work are excellent. A few examples are price reductions at CZ Health Insurance, bonus opportunities and standard 26 days off. Brunel Engineering intermediates both junior and senior engineers within the industry for over 30 years now. Our clients vary from multinationals to local companies. Together we will find the job which meets your wishes.

Over ons

The Product Development department is responsible for the CMC development of new human plasma derived products and processes from phase I until transfer to commercial production. The department consists of four Product Development project leaders, two Process Developers, two Analytical Development technicians and three Development technicians. The team is very diverse in terms of nationalities and background. It is led by the Product Development manager. The department is a part of Sanquin Plasma Products BV, that makes a broad assortment of products from human plasma using ‘state of art’ production technology.

Samenvatting

  • Vacature nummer: PUB226688
  • Standplaats: Noord Holland
  • Markt: Life Sciences & Health Care
  • Uren per week: 40
  • Branche: Healthcare
  • Opleidingsniveau: WO Master
  • Expertisegebied: Medisch
  • Sluitingsdatum: donderdag 31 oktober 2019
Solliciteer

Vragen? Neem contact op

IH

Imre Heezen

Consultant Brunel Netherlands Amsterdam

+31 20 312 1572

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