job description
Are you a passionate MSAT (Manufacturing Science and Technology) / MS&T (Manufacturing Science & Technology) Engineer looking to advance your career in the pharmaceutical industry? Amaris Consulting, a global leader in consulting and engineering services, is seeking a skilled professional to join our team in Bali, Indonesia (locations: Canggu, Ubud, Denpasar, Jimbaran, Nusa Dua, Kuta, or Badung).
In this role, you will play a critical part in ensuring the seamless transition of pharmaceutical products from development to commercial manufacturing. You will collaborate with cross-functional teams, including R&D, Quality Assurance, and Production, to optimize processes, troubleshoot issues, and drive continuous improvement. This is an exciting opportunity to work in a dynamic environment where your expertise will directly impact the success of life-saving pharmaceutical products.
Amaris Consulting offers a collaborative work culture, professional development opportunities, and a chance to work on cutting-edge projects in the pharmaceutical sector. If you are a problem-solver with a strong technical background and a desire to make a difference, we want to hear from you!
Why join Amaris Consulting?
- Work with a globally recognized leader in consulting and engineering.
- Opportunity to work on high-impact pharmaceutical projects.
- Professional growth and development in a supportive environment.
- Competitive salary and benefits package.
- Vibrant work culture in the heart of Bali, Indonesia.
Responsibility
- Support the transfer of pharmaceutical processes from development to commercial manufacturing, ensuring compliance with regulatory standards (e.g., GMP, FDA, EMA).
- Collaborate with cross-functional teams to optimize manufacturing processes, improve efficiency, and reduce costs.
- Troubleshoot and resolve technical issues related to manufacturing, scaling, and process validation.
- Develop and execute process validation protocols, including IQ, OQ, and PQ, to ensure product consistency and quality.
- Analyze process data and implement continuous improvement initiatives using tools like Lean Six Sigma or DMAIC.
- Provide technical support during regulatory inspections and audits, ensuring compliance with global standards.
- Prepare and review technical documentation, including SOPs, batch records, and validation reports.
- Mentor junior engineers and technicians to foster a culture of excellence and innovation.
Qualifications
- Bachelor’s or Master’s degree in Chemical Engineering, Pharmaceutical Engineering, Biotechnology, or a related field.
- Minimum of 3-5 years of experience in MSAT, MS&T, or process engineering within the pharmaceutical or biotech industry.
- Strong knowledge of GMP, FDA, EMA, and ICH guidelines and their application in pharmaceutical manufacturing.
- Experience with process validation, scale-up, and technology transfer in a regulated environment.
- Proficiency in data analysis tools (e.g., Minitab, JMP, Excel) and statistical process control (SPC).
- Familiarity with Lean Six Sigma or DMAIC methodologies is a plus.
- Excellent problem-solving skills and the ability to work in a fast-paced, collaborative environment.
- Strong communication skills in English, both written and verbal.