Qualification and Validation Engineer
Posted on Apr 24, 2021 by ITech Consult
Qualification and Validation Engineer - qualification and validation activities, GMP, English, German
For our client in the Pharma industry based in Basel we are looking for a Qualification and Validation Engineer. The Hiring Manager is looking for a Qualification and Validation Engineer to support the establishment of an excellent distribution technologies group.
The Candidate will be working under general supervision with instructions on new assignments.
The work is regularly reviewed on soundness of judgement, overall adequacy and accuracy, work
priorities and timelines are established with supervision. A key success factor of our function is effective collaboration with supply chain logistics, distribution commercial and clinical quality, clinical supply chain, distribution hubs, internal manufacturing sites, CMOs, technical development as well as regulatory affairs. He/she will provide the necessary leadership, technical expertise and tactical execution to ensure monitoring and thermal shipping systems life cycle efforts on a global level to meet business, regulatory (GDP) and technical requirements.
Areas of responsibility:
* Provide technical expertise in the development, qualification, implementation and maintenance of global monitoring solutions and thermal & tertiary shipping systems.
* Execute small and medium-sized projects or cold chain related sub-project within bigger project, for clinical and commercial supply chain (from cell banking shipment to Finished Products).
* Define goals, develop project execution plans, calculate the business case, ask for endorsement and execute the assigned project.
* Development: Thermal Shipping &Tertiary Packaging and monitoring solutions sourcing,
Translate user requirements into technical requirements, customize solutions for needs if required
* Qualification: Define testing mechanical and thermal profile, conduct qualification, assess design and process risk, Leverage vendor and historical qualification data
* Implementation: Define monitoring and control strategy, provide user guidance and training across network, Support regulatory submission
* Maintenance: Conduct Periodic Review, address recurring excursions/discrepancies and conduct RCA, Conduct change impact assessment
Professional and technical requirements:
* University Degree in a life science or engineering related discipline
* At least 5 years of working experience with qualification and validation activities
* At least 3 years of working experience in a GMP regulated environment
* Very good technical and process understanding
* English required, German as a plus
Nice to Haves:
* Experience with qualification of packaging plants
* Experience in pharma industry
Reference no: 920244 AD
Role: Qualification and Validation Engineer
Industry: Pharmaceutical industry
Location: Basel, Switzerland
Start date: ASAP
Duration: 3 months contract, with possible extension
ITech Consult is a certified ISO 9001:2015 Swiss company with offices also located in Germany and Ireland. ITech Consult is specialised in delivering IT candidates for contract work. We were founded in 1997 by IT professionals; hence we well understand what it means to be professionally supported in your search for a new project and being employed.