Validation Engineer
1 day ago
We at Rieckermann Malaysia are on an exciting journey of growth and are looking for a dynamic Validation Engineers at all levels for our Engineering Operations (EO) portfolio to help us achieve our vision to become "your first-choice industrial solution provider". At Rieckermann, our employees are our most precious asset. We embrace the values Quality, Commitment and Trust, which our colleagues and customers can appreciate in their Rieckermann experience. We welcome ideas and innovative processes that can help us drive our organization further and encourage learning and growth for your continuous professional development.
Rieckermann provides comprehensive consulting and engineering solutions, working with multinational pharmaceutical clients to R&D facilities - across all spectrums of the industry from chemical API, secondary, biopharmaceutical to medical device designers and manufacturers.
Our team offers the comprehensive suite of services, including training, regulatory compliance, auditing, qualification and engineering. Additionally, we offer a range of OEM equipment and tools for the pharmaceutical industry, complete with training, turnkey installation, commissioning, qualification, and maintenance services.
Key Duties:
- Sourcing, specification and selection of new equipment based on minimal user input
- Coordinating with vendors and working with the design teams to ensure a fit for purpose system
- Managing installation and commissioning of the equipment (with vendor support)
- Qualification of the equipment, including preparation of protocols and test plans, execution of the protocols including sample and reagent preparation, preparation of qualification summary reports, and investigation of deviations
- Supporting process technical transfer, including feasibility studies, equipment sizing, process design, process validation and process optimisation
- User training in equipment use and operation
- Supporting cleaning and process validation studies, including cleaning strategy development, protocol development, execution assistance
Job Requirements
- University degree in Engineering, Life Sciences or equivalent
- Minimum 3 years' experience in commissioning and/or validation of biopharmaceutical equipment and processes
- Experienced working in a pharmaceutical or GMP/GLP environment is preferred, although cross-industry expertise is welcomed
- Experienced working under Quality Management Systems
- Excellent interpersonal and communication skills
- Goal-oriented, dynamic, and high sense of responsibility
- Able to work flexibly and under pressure
- Able to work self-reliantly
- Possess excellent customer-oriented work-ethic
- Professional appearance and demeanor
- Very good written and verbal English skills
* This role is available for all levels, employment will be permanent or fixed-term contract roles depending on project *
Company Description: Rieckermann is a privately-owned group of companies providing international industrial solutions. We have more than 750 employees at 24 offices in 17 countries spanning Europe, Asia and the Middle East. We have been in business since 1892 and have established ourselves as a leading provider in our core markets and industries. Our service portfolio covers the entire value chain and scope of industrial plant development in 9 industry sectors: from single unit machines and equipment to complete production lines. We deliver high quality, tailor-made solutions in engineering operations, process technologies and technical services.
Seniority level- Associate
- Contract
- Engineering and Quality Assurance
- Industries: Pharmaceutical Manufacturing
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