Qualification Engineer
- Denmark
- Contract
- Life Sciences
This vacancy has now expired
Our exciting biopharma client based in the Nordics require the support of a Qualification Engineer for a 3 month contractual basis. This role is based in a beautiful location with good transport links, a full expense package included, and competitive hourly rates.
If you want to help an innovative biopharmaceutical company driving the manufacture of biosimilars, and temporarily work within the stunning surrounds that the Nordics offer, this is the role for you.
Qualification Engineer – Smoke Studies Responsibilities:
- Perform and support the execution of smoke (air visualisation) studies on an aseptic filling line (“at rest”, “in operation”, machine set up, and interventions).
- Execute the study in co-operation with local qualification engineer.
- Required equipment (e.g. smoke generator, camera) is available on site
- Operation, set up of filling line and performance of the aseptic interventions is done via manufacturing personnel
- Ensure the compliant execution of the smoke study
- Answer questions from QA related to the executed study
About you:
- Technical education or higher in a related technical discipline
- At least 5 years’ experience with execution of smoke studies in aseptic filling lines
- Knowledge of key GMP processes, e.g. documentation, qualification, change management, user requirement specifications, IQ/OQ/PQ execution
- Knowledge of and experience with GMP documentation and handling of discrepancies
- Knowledge and experience for autoclave qualification of advantage
- Knowledge of regulatory requirements associated with smoke studies in aseptic filling lines
- Communication skills, both written and oral
- Strong interpersonal skills
- Good attention to detail and strictly adherence to SOPs
- Good time planning (stick to timelines)
- Protocol/report writing skills
Are you a good fit for a Qualification Engineer –Smoke Studies? Get in touch with us today.
The candidate must have the rights to work in the location stated in the job advert.
Please note, Quanta part of QCS Staffing does not sponsor Visa applications.
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Once again can I via you recognise the superb support I was given before, during and after this short contract. The support, was as usual professional and every friendly.
QA Specialist
We have worked together with Quanta for seven years now and have always received a professional service. Quanta’s speciality certainly lies within their technical sourcing abilities and they have met our demanding requirements time and time again. Coupled with this are the integrity of Quanta’s people and their ability to deliver.
Global Pharmaceutical firm
I have always received a highly professional & personable service from the team at Quanta. They listen carefully to the specific requirements of available roles and work tirelessly to supply a pool of potential candidates and make the hiring and contract renewal process an easy activity to manage.
Global Pharmaceutical firm
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