GSK

Specialist, Incoming Material Bioprocess & Single Use Systems

3+ months agoWavre, Belgium

Site Name: Belgium-Wavre
Posted Date: Feb 24 2021

The SPU Incoming Material department is managing life cycle of Incoming Material (IM) used by all Belgian Manufacturing Production Unit's (MPU)
The team is focusing on Single Use Systems (SUS), Filters & Purification Items (gel, UF membrane, ...) such as bag for sterile bulk distribution in New IPV & New HAV facilities.

Managing lifecycle of SUS & Filters means being part of different steps: definition, qualification, implementation, deviation support and change notification management.

As IM and SUS Bioprocess Specialist, you are in close connection with all Belgian MPU's to support them in all steps described above. Gemba's & workshop on the shop floor are part of the day to day job.

You will also be involved in audit (internal & external) to bring your expertise to answer any question from auditors linked to SUS & Filters.

Your responsibilities:

  • Individually or as part of a project team, you will be responsible for solution design & qualification to be implemented in primary & secondary process.
  • You will be responsible for the execution, coordination and follow-up of solution designs and technical matters related to Single Use Systems to ensure production, transformation, commissioning and qualification of the solution meets agreed cost, timing, technology and quality standards in line with the Engineering standards.
  • In case of deviation, you will be responsible to investigate potential root cause (within GSK & at the supplier), write appropriate justification in the deviation.
  • You will act as SME for dedicated Single Use System
  • Key activities include:
    • Define functional, technical and quality requirements.
    • Ensure preparation and update of the project qualification and coordinate qualification activities of the systems.
    • Ensure coordination of a multifunction team to enable the creation of single use articles following the internal procedures.
    • Ensure correct systems implementation through training, SOP writing and assistance to the production team.
    • Ensure investigation follow up in case of deviation
    • Ensure definition & implementation of transversal CAPA
Why you?

Basic Qualifications:

We are looking for professionals with these required skills to achieve our goals:
  • University degree in Engineering (or equivalent by experience)
  • 3 to 5 years experience in GMP environment
  • Fluent in French and English (spoken and written)
Preferred Qualifications:

If you have the following characteristics it would be a plus:
  • Basic knowledge in Plastics & Plastics Processing (injection, moulding, ...)
  • Knowledge of qualification/validation principles (V cycle, URS, IOQ, ...)
  • Knowledge of pharmaceutical, aseptic and biotech processes
  • Familiar with Risk Analysis (FMEA) & Quality by design approaches
  • Autonomous, Rigorous, Structured, Systematic, Good analytical skills
  • Ability to lead and impact cross-functional team members without hierarchical authority
  • Quality oriented
  • Experience as investigator/ supplier auditor is an advantage
  • Experience as trainer / setting up training packages is an advantage
*Li-GSK
Why GSK?

Our values and expectations are at the heart of everything we do and form an important part of our culture. These include Patient focus, Transparency, Respect, Integrity along with Courage, Accountability, Development, and Teamwork in a culture of Innovation, Performance and Trust.

GSK Vaccines - Our Vaccines business has a broad portfolio and innovative pipeline of vaccines to protect people of all ages. We deliver over two million vaccine doses per day to people living in over 160 countries.

For further information, please visit www.gsk.com .

Our department:

GIO

Once our pioneering treatments have been developed, they are manufactured to the highest standards and distributed across the regions that need them most. Accomplishing this as efficiently and quickly as possible can quite literally be a matter of life and death. So, it's no wonder that more than 70% of our talented workforce is based within Global Industrial Operations - the essential business unit that manufactures and manages the entire vaccine supply process, from customer order to product dispatch on a global scale.

As the name suggests, it operates in a multi-national context across more than 17 sites around the world, working closely in tandem with colleagues from a variety of disciplines and professions.

The department is structured in operating units that focus on various aspects of the manufacturing and supply process. These include Industrialisation (overseeing the transfer of production from R&D to a commercial level), Supply Chain Management and Technical Services.

At GSK we value diversity and treat all candidates equally. We aim to create an inclusive workplace where all employees feel engaged, supportive of one another, and know their work makes an important contribution.

We provide a supportive working environment, and a range of development challenges and opportunities. We also offer competitive benefits and compensation packages designed to attract and to retain the very best.

If you have a disability and require assistance during the course of the selection process, you will have the opportunity to let us know what specific assistance you require in order to make suitable arrangements.

Our goal is to be one of the world's most innovative, best performing and trusted healthcare companies. We believe that we all bring something unique to GSK and when we combine our knowledge, experiences and styles together, the impact is incredible. Come join our adventure at GSK where you will be inspired to do your best work for our patients and consumers. A place where you can be you, feel good and keep growing.

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Job ID: glaxo-279470-en-us