job description
Join Orka Consulting Partners as a CQV / MSAT Engineer Consultant and accelerate your career in the pharmaceutical and biotech industry. This is a unique opportunity to work on cutting-edge projects while receiving mentorship from seasoned industry leaders in a dynamic, consultative environment.
As a key member of our team, you will play a pivotal role in ensuring compliance, quality, and validation (CQV) for pharmaceutical manufacturing processes, as well as supporting Manufacturing Science and Technology (MSAT) initiatives. You will collaborate with cross-functional teams to optimize processes, troubleshoot technical challenges, and drive continuous improvement in a GMP-regulated environment.
Based in the vibrant and culturally rich regions of Bali, Indonesia, this role offers a perfect blend of professional growth and an exceptional work-life balance. Whether you're in Canggu, Ubud, Denpasar, or the coastal areas of Jimbaran and Nusa Dua, you’ll thrive in an environment that values innovation, expertise, and collaboration.
If you are a detail-oriented, analytical, and results-driven professional with a passion for pharmaceutical engineering, we invite you to apply and take the next step in your career with us.
Responsibility
- Lead Commissioning, Qualification, and Validation (CQV) activities for pharmaceutical equipment, systems, and processes in compliance with GMP, FDA, and ICH guidelines.
- Develop, review, and execute validation protocols (IQ, OQ, PQ) and generate comprehensive validation reports.
- Support Manufacturing Science and Technology (MSAT) initiatives, including process optimization, scale-up, and technology transfer.
- Collaborate with cross-functional teams (QA, Engineering, Production) to ensure seamless project execution and regulatory compliance.
- Identify and implement continuous improvement opportunities to enhance efficiency, quality, and compliance in manufacturing processes.
- Provide technical expertise and troubleshooting for process deviations, investigations, and CAPA (Corrective and Preventive Actions).
- Stay current with industry trends, regulations, and best practices in pharmaceutical manufacturing and validation.
- Mentor junior team members and contribute to knowledge-sharing initiatives within the organization.
Qualifications
- Bachelor’s or Master’s degree in Chemical Engineering, Pharmaceutical Sciences, Biochemical Engineering, or a related field.
- Minimum 3-5 years of experience in CQV, MSAT, or Process Validation within the pharmaceutical or biotech industry.
- Strong knowledge of GMP, FDA 21 CFR Part 11, ICH Q7, and EU Annex 15 regulations.
- Hands-on experience with validation protocols, risk assessments (FMEA), and process characterization.
- Proficient in data analysis, statistical tools (e.g., Minitab, JMP), and process modeling.
- Excellent problem-solving, communication, and project management skills.
- Ability to work in a fast-paced, consultative environment with minimal supervision.
- Willingness to travel to client sites as needed (domestic/international).