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. This role focuses on developing world-class engineering solutions that meet the unique challenges of biotech production.
In this position, you will provide support to Process Engineers in the characterization of new and existing products, maintaining and improving metrology tools, and ensuring process excellence in a high-volume biotech production setting. You will collaborate extensively with various departments including Manufacturing, Equipment Engineering, Analytical Sciences, Facilities, Supply Chain, and Quality Assurance to support new product releases and continuous process improvement.
Scopes & Responsibilities
- Assist Process Engineers in troubleshooting, sustaining, and continuously improving production lines for consumables related to new product development, yield, quality, and throughput.
- Design and execute controlled experiments to optimize processes, while documenting and analyzing results.
- Support MES ticket handling and process verification/validation activities.
- Conduct nonconforming material analysis and investigations.
- Recommend and implement process improvements to meet production goals across multiple operations and technologies.
- Coordinate execution of equipment and process validation, data collection, and report summarization.
- Collaborate with Engineering/R&D teams to develop and refine processes for new and existing products.
- Maintain and update technical documentation, including technical requirements, drawings, and work instructions for engineering and consumables production lines.
Qualifications
- Diploma or Bachelor’s degree in Engineering, Sciences, or related field.
- Experience in manufacturing within a FDA-regulated environment is advantageous.
- Strong understanding of manufacturing processes within a regulated biotech or medical devices environment.
- Ability to execute test plans for components, materials, systems, and processes effectively.
- Proficient in Microsoft Office Suite (Word, Excel, PowerPoint).
- Experience with product & process feasibility studies, line validation, qualification, and process optimization.
- Excellent team collaboration, interpersonal, and communication skills.
- Strong documentation and technical report writing abilities.
- Ability to manage stress and handle multitasking across functions effectively.
- Proactive, innovative, and self-motivated.
