job description
Join a leading Multinational Pharmaceutical Corporation in Bali as a Senior Project Engineer (Biotech/Pharma)! This is a high-impact role for professionals passionate about driving innovation in biotechnology and pharmaceutical manufacturing. You will lead critical engineering projects, ensuring compliance with global standards while optimizing processes for efficiency and scalability.
Based in the vibrant Badung region (covering Canggu, Ubud, Denpasar, Jimbaran, Nusa Dua, or Kuta), this position offers a competitive salary package up to $9,500 annually, along with opportunities to work on cutting-edge projects in a dynamic, fast-paced environment. Ideal candidates will have a strong background in C&Q (Commissioning & Qualification) Engineering, with experience in biotech or pharma facilities.
If you thrive in collaborative settings and are eager to contribute to life-changing healthcare solutions, this is your chance to make a difference with a globally recognized organization.
Responsibility
- Lead Commissioning & Qualification (C&Q) activities for biotech/pharma equipment and systems, ensuring compliance with GMP, FDA, and EMA regulations.
- Develop and execute validation protocols (IQ, OQ, PQ) for new and existing manufacturing processes.
- Collaborate with cross-functional teams (R&D, Production, QA) to design and implement scalable bioprocess solutions.
- Oversee project timelines, budgets, and resource allocation to ensure on-time delivery of engineering initiatives.
- Troubleshoot technical issues and propose cost-effective, compliant solutions to minimize downtime.
- Prepare and review technical documentation, including SOPs, risk assessments, and regulatory submissions.
- Support facility expansions or upgrades with a focus on biocontainment, cleanroom design, and utility systems.
- Mentor junior engineers and provide technical training on biotech/pharma best practices.
Qualifications
- Bachelor’s or Master’s degree in Biochemical Engineering, Chemical Engineering, or related field.
- Minimum 5+ years of experience in C&Q Engineering within the biotech or pharmaceutical industry.
- Proven track record in equipment validation, process optimization, and regulatory compliance (GMP, ISO, 21 CFR Part 11).
- Hands-on experience with bioreactors, chromatography systems, and sterile filling lines.
- Strong knowledge of PLC/SCADA systems, automation, and data integrity principles.
- Excellent project management skills (PMP or PRINCE2 certification is a plus).
- Fluency in English; ability to work in multicultural teams.
- Willingness to relocate to Bali, Indonesia (Badung region preferred).