Change control / cGMP engineer
+32 496 49 18 21
Responsible for the technical support of the production process, root cause analyses, larger projects etc. and ensure the coordination and implementation of continuous improvements within the production department, taking into account all facets within the cGMP guidelines, in order to contribute to the core of our client business (production, ...) can function as optimally and efficiently as possible.
The position is performed in a cGMP environment and must at least comply with all quality and safety requirements and industry standards applicable by the official auditing authorities. This relates to, among other things, production facilities, product safety, qualification of personnel, procedures & documentation.
Applying the employee welfare and environmental and energy management policies in accordance with the training and instructions obtained through, among other things, the correct use of work equipment and personal protective equipment, reporting incidents and non-conformities and providing identification assistance of risks and preventive measures.
The position must also operate within the culture, values and norms.
This is in order to be able to deliver a high-quality, safe and effective product.
- Provide continuous process support and provide both ad hoc and proactive advice, service and technical expertise
- Monitoring processes; adjust and/or escalate where necessary
- Initiating and executing specific investigations into existing and innovative processes and technologies, as well as developing and implementing new (sub)processes and technologies after approval from supervisor
- 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 own department
- Ensure periodic and ad hoc communication about the state of affairs and the preparation of relevant reports
- Proactively follow trends and developments within your own field, as well as build up and share knowledge within this domain
- Initiating consultations with internal and inter-organizational experts across disciplines
- Maintain, adjust and communicate documentation and process knowledge
- Analytical, stress resistant, structured
- Experience in Change Control in GMP environment and/or Deviation handling in a product environment (GMP) (process engineer, change control engineer, cGMP engineer, QA engineer)
- Fulltime, on site work
- Quickly deployable
- Pharma experience & Biotech experience
- Experience within Delta V or SAP is an advantage
- Good knowledge Dutch, good knowledge English (writing)