Process Technician and Technical Writer

About No deviation

At No deviation, we are dedicated to delivering patient-centric solutions that revolutionize the pharmaceutical landscape. As a dynamic expert in engineering consultancy, Commissioning Qualification Validation (CQV), and Quality, Compliance, and Regulatory services, we are looking for individuals who are excited to contribute to impactful projects and drive innovation.

We believe that great things happen when Empathy, Integrity, and Transparency guide our actions. That's why we foster a culture of collaboration, inclusion, and continuous development – empowering our team members to grow personally and professionally.

Position Overview

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.

Key Responsibilities

1. Assist Process Engineers in troubleshooting, sustaining, and continuously improving production lines for consumables related to new product development, yield, quality, and throughput.
2. Design and execute controlled experiments to optimize processes, while documenting and analyzing results.
3. Support MES ticket handling and process verification/validation activities.
4. Conduct nonconforming material analysis and investigations.
5. Recommend and implement process improvements to meet production goals across multiple operations and technologies.
6. Coordinate execution of equipment and process validation, data collection, and report summarization.
7. Collaborate with Engineering/R&D teams to develop and refine processes for new and existing products.
8. Maintain and update technical documentation, including technical requirements, drawings, and work instructions for engineering and consumables production lines.

Required Qualifications

1. Diploma or Bachelor’s degree in Engineering, Sciences, or related field.
2. Experience in manufacturing within a FDA-regulated environment is advantageous.
3. Strong understanding of manufacturing processes within a regulated biotech or medical devices environment.
4. Ability to execute test plans for components, materials, systems, and processes effectively.
5. Proficient in Microsoft Office Suite (Word, Excel, PowerPoint).
6. Experience with product & process feasibility studies, line validation, qualification, and process optimization.
7. Excellent team collaboration, interpersonal, and communication skills.
8. Strong documentation and technical report writing abilities.
9. Ability to manage stress and handle multitasking across functions effectively.
10. Proactive, innovative, and self-motivated.

Why join us?

1. Generous Leave Policy including 3 days to care for aging family members, reflecting our commitment to family wellbeing.
2. Comprehensive Health & Wellness Coverage: Receive robust medical and dental coverage to support your health needs.
3. Professional Development Opportunities: Access continuous learning programs and resources for career growth within the company.
4. Inclusive Culture: Work in an environment where innovation, collaboration, and diverse perspectives are encouraged and celebrated.
5. Shape the Future: Make a real difference in the pharmaceutical industry while advancing your career.

How to apply

Are you ready to play a key role in shaping the future of pharmaceutical solutions? If you're passionate about making an impact, we want you on our team!

Please submit your resume, outlining your qualifications and experience relevant to the role, here.