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Pharma Process Engineer CCR

  • Location:

    Geel, Belgium

  • Contact:

    Sebastien Barxhon

  • Job type:

    Contract

  • Contact phone:

    0032 15445882

  • Industry:

    Pharmaceutical , Biotechnology

  • Contact email:

    sebastien_barxhon@oxfordcorp.com

Are you interested in a process engineer position for change control records in a big biotech company?

Job Description

Responsible for the technical support of the production process, root cause analyzes, larger projects etc. and ensure the coordination and implementation of continuous improvements within the production department, taking into account all aspects within the cGMP guidelines, in order to contribute to the core company business (production, ...) can function as optimally and efficiently as possible.

Function is performed in a cGMP environment and must at least meet all quality and safety requirements and industry standards applicable by the official auditing bodies. This concerns, among other things, production facilities, product safety, qualification of the personnel, procedures & documentation.

Apply workers' wellbeing and environmental and energy management policies in accordance with training and instructions obtained, including the proper use of work equipment and personal protective equipment, incident and non-conformity reporting, and identification assistance of risks and preventive measures.

Responsibilities
  • Providing continuous process support and providing ad hoc as well as proactive advice, service and technical expertise.
  • Guarantee efficiency of production processes. Monitoring processes, adjusting and / or escalating where necessary. Preventing deviations from standards, solving bottlenecks and identifying improvement opportunities.
  • Initiate and conduct specific investigations into existing and innovative processes and technologies after approval from manager. Contribute to optimizing the effectiveness and efficiency of the team. Anticipating and solving any structural problems.
  • Writing, revising, providing input and training of operational procedures, assisting in the implementation of new procedures, and ensuring correct compliance with SHE guidelines, house rules, GMP guidelines, legal standards, regulations and regulations within the own department. Let processes and procedures run as efficiently and safely as possible.
  • Periodically and ad hoc ensuring communication about the state of affairs and the preparation of relevant reports. Ensuring correct exchange of information with all relevant parties involved (manager, colleagues, other departments, ...).
  • Proactive follow up of trends and developments within one's own field, as well as building and sharing knowledge within this domain. These developments translate into accurate and relevant information for the organization and can provide expert advice.
  • Initiate consultation with internal and interorganizational experts across the disciplines. To arrive at a substantiated, supported and integrated approach.
  • Keeping, adjusting and communicating documentation and process knowledge. Contribute to the transfer of knowledge and guarantee the traceability and correctness of collected data.

Requirements
  • Master Process Technology or at least a bachelor biotechnology, biochemistry
  • Experience with CCR’s, experience in process technology
  • Experience with quality systems
  • Experience with cGMP rules
  • Quality minded
  • Experience with Trackwise is a nice to have
  • Strong in meeting deadlines, but also flexible when another priority comes up
  • Stress resistant and communicative
  • Set priorities independently
  • Accurate, planned and organizational
  • Technical knowledge of process equipment and process and production systems, being able to check work orders, read plans, ...

Benefits
  • Challenging project for 9 months
  • Full-time - 40hrs / week – 5 days / week
  • Location Geel area
  • Start date ASAP