No Deviation is a provider of patient-centric solutions for the pharmaceutical industry, and we are currently seeking individuals who are passionate about joining our team.
Our areas of expertise include engineering consultancy, Commissioning Qualification Validation (CQV), as well as Quality, Compliance, and Regulatory services.
We strongly uphold our core values of Empathy, Integrity, and Transparency, and we strive to create a collaborative, innovative, and inclusive work environment that fosters personal growth and development.
By joining our team, you will have the opportunity to make a meaningful impact in the pharmaceutical industry while advancing your career.
Scope and Responsibilities:
- Coordinate equipment and process validation execution, data collection and summaries.
- Perform documentation and release technical requirements/ drawings, write, review or update work instructions for engineering and consumables production lines.
- Assist in MES ticket and process verification/ validation activities.
- Assist Process Engineers in providing direct support to troubleshooting, sustaining and continuous improvement for consumables production lines related to new product development, yield, quality and throughput.
- Recommend and assist in implementation of improvements in a production environment to meet goals across multiple operations and technologies.
- Assist with design and execution of controlled experiments to optimize processes; document and analyze process test results.
- Support with Engineering/ R&D teams to develop processes for new products and improve processes of existing products.
- Supports nonconforming material analysis and investigations.
Qualifications:
- Possess good understanding of manufacturing process and regulated biotech or medical devices manufacturing environment.
- Capable of executing test plans for components, materials, systems and processes.
- Competent in Microsoft word, excel, powerpoint
- Knowledge in product & process feasibility study, line validation, qualification and optimization to production
- Excellent team player, interpersonal and communication skill.
- Well-developed documentation and technical report writing skills
- Able to work well under stress, both internally and across functions and perform multitasking.
- Proactive, innovative and self-motivating.
- Team player with strong focus on safety, quality and timeline.
- Diploma/ Bachelor in Engineering, Sciences or related field
- Experience in manufacturing/ FDA-regulated environment is a plus.
