Downstream Biotechnologist
12 hours ago
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
We are looking for a proactive and hands-on Biotechnologist to support brownfield facility expansion activities in a regulated biopharmaceutical environment. This role focuses on preparing manufacturing operations for startup, including equipment readiness, documentation review, mock runs, and supporting process validation and GMP transition.
You will work closely with Manufacturing, Process Engineering, CQV, and Quality teams to ensure a smooth handover from project to operations for areas such as upstream, downstream, media/buffer preparation, or formulation/fill depending on project scope.
Key Responsibilities
- Support equipment and facility readiness activities, including area walkthroughs, punch list closure, and the setup of preparation and production areas.
- Contribute to the development and review of batch records, standard operating procedures (SOPs), work instructions, and material/equipment lists.
- Assist in planning and executing mock runs, operator training sessions, and GMP simulations.
- Work closely with cross-functional teams to ensure processes, workflows, and documentation align with GMP and operational requirements.
- Support process verifications, sampling plans, and data collection activities during startup runs.
- Provide on-the-floor support during commissioning, qualification, and process validation phases.
- Perform basic troubleshooting and escalate technical issues to the appropriate teams when necessary.
- Ensure adherence to safety, environmental, and GMP regulations throughout all activities.
- Leverage experience in optimize downstream processes (e.g., filtration, chromatography, centrifugation) for large-scale production.
Required Qualifications
- Diploma or degree in Biotechnology, Life Sciences, Biochemical Engineering, or a related field
- 3-8 years of relevant experience in a biotech or biopharmaceutical GMP environment
- Exposure to facility startup, tech transfer, or brownfield/greenfield projects is an advantage
- Basic understanding of bioprocess operations (upstream, downstream, or support functions)
- Familiarity with cleanroom protocols, buffer/media prep, and GMP documentation
- Strong interpersonal, communication, and problem-solving skills
- Able to work independently and collaboratively in a fast-paced project environment
Why join us?
- Generous Leave Policy.
- Comprehensive Health & Wellness Coverage: Receive robust medical and dental coverage to support your health needs.
- Professional Development Opportunities: Access continuous learning programs and resources for career growth within the company.
- Inclusive Culture: Work in an environment where innovation, collaboration, and diverse perspectives are encouraged and celebrated.
- 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.
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